Internet-based cognitive behavioral therapy for individuals with gambling disorder in Indonesia: protocol for a pilot and feasibility study

Kristiana Siste; Enjeline Hanafi; Belinda Julivia Murtani; Michael Baigent; Ben J Riley; Jayne Sessions; Lee Thung Sen; Hans Christian; Astria Aryani; Kevin Surya Kusuma

doi:10.12688/f1000research.151009.2

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Study Protocol

Revised

Internet-based cognitive behavioral therapy for individuals with gambling disorder in Indonesia: protocol for a pilot and feasibility study

[version 2; peer review: 2 approved]

Kristiana Siste ¹, Enjeline Hanafi¹, Belinda Julivia Murtani¹, [...] Michael Baigent², Ben J Riley², Jayne Sessions², Lee Thung Sen¹, Hans Christian¹, Astria Aryani¹, Kevin Surya Kusuma¹

Kristiana Siste ¹, Enjeline Hanafi¹, [...] Belinda Julivia Murtani¹, Michael Baigent², Ben J Riley², Jayne Sessions², Lee Thung Sen¹, Hans Christian¹, Astria Aryani¹, Kevin Surya Kusuma¹

PUBLISHED 23 Sep 2024

Author details Author details

¹ Department of Psychiatry, Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia
² Department of Psychiatry, College of Medicine and Public Health, Flinders University and Flinders Centre for Gambling Research, Statewide Gambling Therapy Service, Flinders Medical Centre, Flinders University, Adelaide, South Australia, Australia

Kristiana Siste
Roles: Conceptualization, Funding Acquisition, Supervision, Writing – Review & Editing

Enjeline Hanafi
Roles: Conceptualization, Project Administration

Belinda Julivia Murtani
Roles: Project Administration, Writing – Original Draft Preparation

Michael Baigent
Roles: Resources, Writing – Review & Editing

Ben J Riley
Roles: Resources, Writing – Review & Editing

Jayne Sessions
Roles: Resources, Writing – Review & Editing

Lee Thung Sen
Roles: Methodology, Writing – Original Draft Preparation

Hans Christian
Roles: Methodology, Writing – Original Draft Preparation

Astria Aryani
Roles: Writing – Original Draft Preparation

Kevin Surya Kusuma
Roles: Writing – Original Draft Preparation

OPEN PEER REVIEW

REVIEWER STATUS

This article is included in the Gambling and Gaming Addiction collection.

Abstract

Background

Gambling disorder (GD) has become a wide concern in Indonesia, as many negative consequences arise from this psychiatric condition. Prompt treatment with an appropriate method of delivery is required to achieve optimal outcomes in GD patients. This protocol paper outlines a study to determine the effectiveness, acceptability, and feasibility of internet-based cognitive behavioral therapy (iCBT) in treating GD in Indonesia.

Methods

This non-randomized pilot and feasibility study will recruit 20 people with GD. All participants will receive the iCBT intervention through self-learning videos and guided weekly group sessions. The effectiveness of the intervention will be assessed at baseline (week 0), post- treatment completion (week 10), and 6 weeks post-treatment (week 16). The outcomes measured will be the change in gambling symptoms, gambling urges, cognitive distortions, readiness to change, emotional problems, and quality of life of the participants.

Discussion

The feasibility of iCBT for GD patients in Indonesia will be assessed by this study. The study’s results will give an indication of the acceptability of the intervention and the feasibility of a subsequent conclusive trial. The delivery of iCBT may help to address the issue of treatment access in an extensive geographical region and provide immediate implications as a treatment resource for GD in practice.

Keywords

gambling disorder, internet based, cognitive behavioral therapy, treatment, Indonesia

Corresponding author: Kristiana Siste

Competing interests: No competing interests were disclosed.

Grant information: This work was supported by Universitas Indonesia (Grant Number NKB- 655/UN2.RST/HKP.05.00/2023). The funders had no role in the design of this protocol or writing of this manuscript.
The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Copyright: © 2024 Siste K et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

How to cite: Siste K, Hanafi E, Murtani BJ et al. Internet-based cognitive behavioral therapy for individuals with gambling disorder in Indonesia: protocol for a pilot and feasibility study [version 2; peer review: 2 approved]. F1000Research 2024, 13:689 (https://doi.org/10.12688/f1000research.151009.2) First published: 25 Jun 2024, 13:689 (https://doi.org/10.12688/f1000research.151009.1) Latest published: 23 Sep 2024, 13:689 (https://doi.org/10.12688/f1000research.151009.2)

Revised Amendments from Version 1

The new version of our article clarifies our aims of the study. We updated the number of help-seeking behavior among person with problem gambling stated in the introduction. In the study design, we explained that there will be individual online learning sessions and group therapy sessions both held online. Elaboration about implemented behavior changes techniques (BCT) in our module can be seen in Table 2. We revised in this version that there will be no drop out criteria in the study. Outcomes of the study are now classified into primary and secondary outcomes to provide clearer goals, additional evaluation from participants regarding the iCBT sessions was also added to assess the acceptability of the program. There are revision on the sample size formula used, however the minimum sample size remains the same. The method used to evaluate responses to the intervention was changed into mixed model analyses.

See the authors' detailed response to the review by David C Hodgins
See the authors' detailed response to the review by Simone N Rodda

Introduction

According to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5), gambling disorder is defined as a persistent and recurrent problematic gambling behavior that results in substantial clinical impairment or distress.¹ The issue of gambling disorder (GD) is growing worldwide. In recent years, more people have access to both offline and online gambling. In addition, the COVID-19 pandemic corresponded with an increase in online gambling platforms.³^,⁴ A study in Indonesia during the pandemic found the prevalence of GD in Indonesia is estimated to be 1% in 2021.² This is an enormous figure as Indonesia comprised up to 278 million people.³Low public awareness and a lack of effective regulation could eventually cause the number of individuals experiencing GD to rise in the future.³^,⁵

Gambling disorder causes major impacts in life including unemployment, interpersonal problems, financial difficulties, and an increased risk of other mental disorders such as depression, anxiety disorders, stress-related and somatoform disorders, along with substance use disorder.² Therefore, it is essential to provide suitable treatment for gambling disorders. Early intervention and appropriate management have been shown to significantly improve outcomes for individuals with gambling disorders.⁶^,⁷

The goal of GD treatment is symptom remission and functional recovery. To date, no pharmacological treatment has been approved for GD. However, some studies have demonstrated positive outcomes when pharmacological and psychotherapy treatments are combined.⁸ Cognitive behavioral therapy (CBT) is an effective treatment modality for GD.⁸^,⁹ Studies reveal that CBT reduces gambling-related symptoms and problematic behavior whilst also improving the overall functioning and quality of life of people with GD.⁷^,⁹ In recent years, internet-based cognitive behavioral therapy (iCBT) has been suggested as a means of lowering barriers to professional help seeking by showing equally promising outcomes with increased accessibility, convenience, and cost-effectiveness.¹⁰^–¹² Studies of help-seeking among individuals with gambling problems consistently report very few gamblers seek formal help, with only 1 in 25 moderate-risk gamblers have sought help for gambling-related issues, and 1 in 5 people with problem gambling have engaged in similar help seeking actions.⁵ Similar findings also come from an Indonesian study that indicated only 15.5% of people seek treatment for GD.² Problem gambling and its consequences can remain hidden within families, usually over extended periods, and help-seeking is often the last resort after significant adverse events or crises such as family breakdown, loss of employment, legal issues, or deterioration of mental health.¹³^,¹⁴ Since delivering treatment for gambling disorders is challenging in Indonesia due to its vast and varied territory, iCBT appears to be a promising treatment option. However, research regarding the effectiveness of iCBT is still very scarce in Indonesia. This pilot study aims to examine the effectiveness, acceptability and feasibility of iCBT for GD in Indonesia.

PROTOCOL

Methods

Study design

This study is a pilot and feasibility study with a quasi-experimental design. The protocol adheres to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) checklist (Extended data: Supplementary file 1).¹⁵ After intake screening, participants will undergo baseline assessment (T1) and will be given treatment for 10 weeks. The treatment will consist of individual online learning sessions delivered through pre-recorded videos, followed by weekly online group therapy sessions with a therapist. Each group therapy session will include five participants. This will be followed by follow up assessment immediately after treatment (T2) and follow up assessment 6 weeks after treatment (T3) (Figure 1).

Figure 1. Study flowchart.

Participants and settings

A total of 20 participants screened as probable pathological gambler (indicating severe and pervasive problem gambling) based on South Oaks Gambling Screen (SOGS) will be recruited using online advertisements via social media and through consecutive sampling by directly approaching current and former patients in inpatient and outpatient services in Cipto Mangunkusumo Hospital, Indonesia. All participants will be allowed to continue their prior treatment as indicated.

The inclusion criteria include age between 18-59 years old, fluent in Bahasa Indonesia, be diagnosed as person with GD using ICD-11 by medical doctors at Dr. Cipto Mangunkusumo General Hospital, Jakarta, Indonesia. Exclusion criteria are no history of gambling in the past six months, history of severe psychiatric disorder (i.e., psychotic disorders, severe mood disorders, and intellectual disability), history of neuropsychiatric disorders (e.g., seizures), and inability to access web browsers and online conferencing platforms. There will be no drop out criteria in this study. Adherence to the treatment will be evaluated to optimize the configuration of the iCBT for future studies.

The South Oaks Gambling Screen is chosen as a screening tool because of its widespread use internationally.¹⁶ The adaptation to Indonesian version in community setting yielded a good validity and reliability testing, indicating SOGS as a good instrument to screen for GD in Indonesia.²

Following the determination of a participant’s eligibility, several instruments will be employed to assess the effectiveness of the study. The primary outcomes will be evaluated using the Indonesian version of the Gambling Symptom Assessment Scale (G-SAS) to measure gambling symptoms, the Gambling Urge Scale (GUS) to assess gambling urges, and the Gambling Related Cognitions Scale (GRCS) to evaluate cognitive distortions. Secondary outcomes will be measured using the Barratt Impulsiveness Scale-11 (BIS-11) to assess impulsivity, the University of Rhode Island Change Assessment Scale (URICA) to gauge readiness to change, the World Health Organization Quality-of-Life Scale (WHOQOL-BREF) to evaluate quality of life, and the Self Rating Questionnaire-20 (SRQ-20) to assess emotional problems.¹⁷^–²⁷ The assessment schedule is presented in Table 1 and Figure 2.

Table 1. Outcome and measurement.

Outcome	Measurement	Data for analysis	Type and score range	Hypothesis	Assessment time point
Outcome	Measurement	Data for analysis	Type and score range	Hypothesis	T1	T2	T3
Gambling symptom severity	G-SAS	Sum of 12 items	Continuous, 8 (mild) to 48 (extreme)	Lower	v	v	v
Gambling urges	GUS	Sum of 6 items	Continuous, 0 to 42, the higher the score indicating the higher the urges/craving	Lower	v	v	v
Gambling- related cognitive distortions	GRCS	5 domains, with the highest percentage being the most dominant domain.	Continuous, 0% to 100% per domain	Lower	v	v	v
Impulsivity	BIS_11	Sum of 30 items	Continuous, 30 to 120, the higher the score indicating the higher levels of impulsivity	Lower	v	v	v
Readiness to change	URICA	Means of each stage of change score	Continuous, means of 9.3 (pre-contemplation), 11 (contemplation) and 12.6 (participation)	Lower	v	v	v
Nonspecific psychological distress	SRQ-20	Sum of 20 items	Continuous, 0 to 20, with scores >5 indicating mental distress	Lower	v	v	v
Quality of life	WHOQOL- BREF	4 domains, with transformed score used	Continuous, 0 to 100 per domain, the higher the score the higher the quality of life	Higher	v	v	v

Figure 2. Study timeline.

Development of the iCBT

The iCBT module was developed by researchers from Department of Psychiatry, Faculty of Medicine, Universitas Indonesia and Department of Psychiatry, Flinders Centre for Gambling Research, South Australia. This module consists of 6 parts which will be used as a guide for the therapist in the therapy sessions. The module content for each session is described in Table 2.

Table 2. Description of iCBT module content.

Session	Content	Behavior Change Technique²⁸	Delivery	Targetted Outcome
1	Building rapport and assessment	-	Online video and online group CBT session	URICA, SRQ-20, WHOQOL-BREF
2	Psychoeducation and objectives	• Goal-setting (behavior) • Goal-setting (outcome) • Discrepancy between current behavior and goal • Pros and cons • Verbal persuasion about capability • Commitment	Online video and online group CBT session	Improvement in GUS, GSAS, GRCS score
3	Understanding gambling disorder Exposure therapy (first exposure task)	• Information about health consequences • Information about social and environmental consequences • Information about emotional consequences • Exposure	Online video and online group CBT session	Improvement in GUS, GSAS, GRCS, and BIS11 score
4	Identification of gambling thoughts and cravings Review of first exposure therapy task and planning of next exposure task	• Problem-solving • Exposure • Graded tasks • Feedback on behavior	Online video and online group CBT session	Improvement in GUS, GSAS, GRCS, and BIS11 score
5-9	Exposure therapy	• Problem-solving • Exposure • Graded tasks • Feedback on behavior	Online video and online group CBT session	Improvement in GUS, GSAS, GRCS, and BIS11 score
10	Relapse and prevention strategies	• Problem-solving • Review outccome goals • Commitment	Online video and online group CBT session

The contents of iCBT module are largely derived from The Flinders/Statewide Gambling Therapy Service (SGTS) Model of Treatment for Gambling Disorders, a manualized CBT treatment program.²⁹^,³⁰ The beginning of the program addresses topics such as the severity of gambling, the level of motivation, comorbidities, money management, and support systems. The intervention approach then provides psychoeducation and outlines objectives of the therapy for the participants and their significant others, aiding them with the understanding of gambling behavior, and how to identify distorted gambling thoughts and correct them. Exposure therapy including guided imagery is introduced and used to extinguish urges. Relapse prevention strategies are also included with ways to implement a balanced lifestyle, managing lapses and relapses, and ongoing money management.

Delivering the intervention

All participants will undergo 10 online therapy sessions (once-weekly) with each session lasting for 40-60 minutes. They will be divided into four small groups, each comprising five participants and a therapist. Before each session, the therapy module will be given as an online self-learning source via videos in a website specifically developed for this training. The videos will divide the module content into several parts with each video lasting about 10 minutes. To confirm the participants have watched the videos, there will be a post-test measurement with no passing mark as the purpose is to assert the important points contained in the videos. The participants will then be encouraged to discuss things they understand or do not understand from their online self- learning sessions during each therapy session. There will also be several tasks that must be completed by the participants and then discussed with the therapist during each therapy session (e.g., ‘please identify the urges you feel over the next week’). To evaluate acceptability, participants will complete a satisfaction questionnaire after each therapy session. The questionnaire will use a five-point Likert scale, ranging from “very unsatisfied” to “very satisfied,” to measure their level of satisfaction with the iCBT sessions. Researchers from Flinders Centre for Gambling Research and Universitas Indonesia will meet online every two weeks to discuss participants and to provide input on treatment.

Providers of iCBT

Two psychiatrists with expertise in GD from Department of Psychiatry, Faculty of Medicine, Universitas Indonesia will facilitate each group session in this study. The roles of the therapist are to: (1) lead and moderate iCBT sessions based on (but not limited to) the module, (2) establish a safe and warm environment, (3) provide consultation, including out-of-session, and (4) contact absent participants to encourage attendance.

Participant characteristics

The following descriptive data will be obtained via a self-administered questionnaire: age, gender, education level, ethnicity, religion, approximate residential location, marital status, employment status, monthly income, last gambling session, age during first instance of gambling, frequency of gambling in a month, first person to introduce gambling, other people around the patient who also have gambling problems, media used to gamble, types of device used, types of gambling played, average duration of gambling during weekday and weekend, lowest and highest bet ever placed, total money lost to gambling, purpose of gambling, negative impacts from gambling, help seeking behaviors, substance use history, usage of substance during gambling session, and (if ever) rehabilitation due to substance use history.

Sample size

The sample size for this study was determined using the formula for matched samples continuous outcome: n = ((Z_α + Z_β) × S/E)², where Z_α is the value from the standard normal distribution reflecting the confidence level that will be used (Z_α = 1.96 for 95%), power is determined to be 80% (Z_β = 0.84). S is the standard deviation score using GUS as primary outcome, which is 11 from a previous study.³¹ Margin of error was determined to be 5 units. The sample size needed using the above formula is 19.36 samples, which is then rounded to 20 samples to accommodate the group therapy sessions.

Statistical analysis

Evaluation of the response to CBT will be measured using mixed model analyses. Statistical analysis will be carried out using the Statistical Package for the Social Sciences (SPSS) software version 25.0. The raw data obtained in this study only be accessible to the authors. Missing data will be handled on whether they are at random.

Data monitoring

Data on adverse events, including hospitalization, arrest, and death, will be collected from the participants’ contact person, treating physician or medical staff. In addition, participants will be interviewed at T2 to determine whether they have experienced any subjective harmful effects (e.g., withdrawal syndrome, increased cravings) after joining this program.

Study status

At the time of submission, the study had not begun any recruitment.

Dissemination

The results of this study will be disseminated via peer-reviewed journals and international academic conferences. All procedures of this study will be independent from the sponsor. Participant-level dataset will not be made publicly available. Any authors included in the publications will be determined according to authorship guideline of the International Committee of Medical Journal Editors (ICMJE).

Discussion

The aim of our study is to evaluate the effectiveness, acceptability and feasibility of an online CBT intervention for patients with GD in Indonesia. Previous studies found that only few of those with gambling problems seek professional help.²^,⁵^,²³ Multidimensional factors including social, cultural, and personal could be contributing to their reluctance to seek treatment. There are a number of obstacles that inhibit help-seeking such as pressure from others to continue gambling, the desire to handle the issues on their own, stigma, secrecy, shame, not admitting problems, practical concerns (such as lack of availability and cost of treatment), worries about treatment, uncertainty, and avoidance.³²^–³⁴ Gambling is strictly prohibited under the Indonesian Criminal Code and engaging in such activities is punishable by law.³⁵ Although there is currently no research on the subject, it is possible that the illegality of GD is one of the contributing factors to the low rate of help-seeking in GD. Internet-based therapies have the potential to address these barriers by minimizing the stigma associated with seeking treatment, as participants are not required to attend a physical therapy site. Additionally, they help to overcome practical challenges, such as travel time to treatment facilities and scheduling conflicts with other obligations, including childcare and paid work. Furthermore, these therapies can be tailored to meet cultural and language needs to geographically challenging areas, enhancing their acceptability among the target population.³⁶ Group CBT model is selected because it is not inferior to individual CBT in terms of efficacy, while being more resource-efficient.³⁷^,³⁸ This approach allows for the treatment of a larger number of individuals with GD, particularly in resource-limited settings, such as those found in LMICs especially Indonesia, where participants are spread across multiple islands. However, maintaining the confidentiality of personal information among participants must be prioritized throughout the therapy sessions.

To our knowledge, our study will be the first to examine the effectiveness, acceptability and feasibility of a CBT program which will be delivered online for patients with GD in Indonesia. The outcome of this study will provide valuable data for the development of iCBT for individuals with addiction, particularly GD in LMIC. This established module may be a beneficial addition to the resources of treatment for GD in practice.

Evidence-based treatments for GD in Indonesia and LMICs in general remain sparse. The proposed study may provide an alternative to conventional CBT when physical accessibility is an issue (as many experienced during the COVID-19 pandemic), or when the patients have limited access to professional help locally. As a result of this study’s findings, iCBT might be applied in a more widespread context and utilized as a module to assist psychiatrists in engaging and treating more GD patients throughout Indonesia.

Ethical consideration

The study protocol was approved by the Research Ethical Committee of Faculty of Medicine, Universitas Indonesia (approval number: KET-992/UN2.F1/ETIK/PPM.00.02/2023) which was issued on 24^th of July 2023. The study protocol was registered at ClinicalTrials.gov (NCT number: NCT06171516 on 14^th December 2023). The study will be conducted in accordance with the Declaration of Helsinki 1969, revision 2013.

All participants will be provided with and asked to sign a patient information and consent form (PICF). The results will be submitted for publication after finalizing the study. Personal data will be protected by separating the study data from the participants’ identifiable information and importantly, written agreement will be obtained from participants to never share others’ information with any third party even after the therapy is finished.

Contributors

KS and EH conceptualised the study. KS, EH and BJM are the main developers of the iCBT module. MB, BJR, and JS reviewed the iCBT module. LTS and HC helped in designing study methodology. BJM, LTS, HC, AA, and KSK wrote the protocol and initial manuscript. KS, MB, BJR and JS reviewed and edited the final manuscript. KS supervised the whole study and procured grants. All authors have read and approved the final manuscript.

Ethics and dissemination

The study protocol was reviewed and approved by the Research Ethical Committee of Universitas Indonesia on 24^th of July 2023 (approval number: KET-992/UN2.F1/ETIK/PPM.00.02/2023). All participants will be provided with and asked to sign a patient information and consent form (PICF). The study will adhere to the Declaration of Helsinki 1964, revision 2013. The results will be submitted for publication after finalizing the study.

Trial Registration

The trial is registered on the 14^th of December 2023 at the ClinicalTrials.gov database with the identifier number NCT06171516.

Data availability

Underlying data

No data is associated with this protocol article.

Reporting guideline

OSF: Internet-based cognitive behavioral therapy for individuals with gambling disorder in Indonesia: protocol for a pilot and feasibility study, https://doi.org/10.17605/OSF.IO/JB7F5.³⁹ Licensed under CC-BY 4.0 International.

The project includes:

• Spirit checklist

Acknowledgements

We would like to thank the Flinders Centre for Gambling Research for their participation in designing the iCBT module.

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Version 2

VERSION 2 PUBLISHED 25 Jun 2024

Author details Author details

Kristiana Siste
Roles: Conceptualization, Funding Acquisition, Supervision, Writing – Review & Editing

Enjeline Hanafi
Roles: Conceptualization, Project Administration

Belinda Julivia Murtani
Roles: Project Administration, Writing – Original Draft Preparation

Michael Baigent
Roles: Resources, Writing – Review & Editing

Ben J Riley
Roles: Resources, Writing – Review & Editing

Jayne Sessions
Roles: Resources, Writing – Review & Editing

Lee Thung Sen
Roles: Methodology, Writing – Original Draft Preparation

Hans Christian
Roles: Methodology, Writing – Original Draft Preparation

Astria Aryani
Roles: Writing – Original Draft Preparation

Kevin Surya Kusuma
Roles: Writing – Original Draft Preparation

Competing interests

No competing interests were disclosed.

Grant information

This work was supported by Universitas Indonesia (Grant Number NKB- 655/UN2.RST/HKP.05.00/2023). The funders had no role in the design of this protocol or writing of this manuscript.
The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

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Published: 23 Sep 2024, 13:689

https://doi.org/10.12688/f1000research.151009.2

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https://doi.org/10.12688/f1000research.151009.1

© 2024 Siste K et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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Siste K, Hanafi E, Murtani BJ et al. Internet-based cognitive behavioral therapy for individuals with gambling disorder in Indonesia: protocol for a pilot and feasibility study [version 2; peer review: 2 approved]. F1000Research 2024, 13:689 (https://doi.org/10.12688/f1000research.151009.2)

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Reviewer Report 14 Oct 2024

Simone N Rodda, Department of Psychology and Neuroscience, Auckland University of Technology, Auckland, Auckland, New Zealand

Approved

https://doi.org/10.5256/f1000research.172058.r326139

Thank you for addressing my comments. Article looks great. Perhaps consider being clear on the ... Continue reading

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Reviewer Report 28 Sep 2024

David C Hodgins, University of Calgary, Calgary, Alberta, Canada

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https://doi.org/10.5256/f1000research.172058.r326140

No further comments. Suggestions ... Continue reading

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Reviewer Report 06 Sep 2024

David C Hodgins, University of Calgary, Calgary, Alberta, Canada

Approved with Reservations

https://doi.org/10.5256/f1000research.165628.r320594

This is an interesting and well written proposal. I am very eager to hear about the results and conclusions as we have lots to learn about how to provide effective treatment. I was able to review the comments of the first reviewer, Dr. Rodda, and I concur with all her points. I have several additional queries and suggestions.
Design:
First, the protocol would benefit from identifying the primary and secondary outcomes. The goals in the abstract are threefold -assessing effectiveness, acceptability, and feasibility. (The article text identifies only 2 aims - acceptability and feasibility - although effectiveness is implicitly assumed by the methods). It would be helpful to identify how these goals will be assessed and evaluated as successful or unsuccessful. One primary outcome for effectiveness should be identified. The sample size calculation refers to a standard deviation, but the instrument/variable is unspecified.
Participants:
One method of recruitment is approaching current patients in inpatient and outpatient services. Would these patients be receiving treatment for gambling disorder, which seems like an unnecessary confound?
Eligibility includes ICD-11 Gambling Disorder assessed by a psychiatrist. Unfortunately, no standardized instrument exists for assessing these ICD criteria. The lack of an instrument may be problematic for reliably assessing status at follow-up. Perhaps an assessment of DSM-5 Gambling Disorder criteria with a standardized instrument such as the NODS might be more reliable? Will the psychiatrists that provide the treatment also be conducting the follow-up diagnostic assessments?
Statistical Analysis:
The analytic plan is briefly described. Repeated measure ANOVA is proposed. Given that there are three time points, a mixed model analyses would better handle missing data. This analytic model would also allow inclusion of a nested “group” variable. It is unclear whether “dropouts” will be followed but they should be included if possible. I agree with Dr. Rodda that the definition of dropout seems arbitrary given that this is a pilot study.
Discussion:
A minor point is that the discussion describes internet interventions as possibly fostering a sense of anonymity. Given that one of the novel aspects of this intervention is the group sessions, this advantage is unlikely to apply here.

Is the rationale for, and objectives of, the study clearly described?

Yes
Is the study design appropriate for the research question?

Yes
Are sufficient details of the methods provided to allow replication by others?

Yes
Are the datasets clearly presented in a useable and accessible format?

Not applicable

Competing Interests: No competing interests were disclosed.

Reviewer Expertise: Gambling disorders, including intervention.

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above.

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Author Response 23 Sep 2024

Kristiana Siste, Department of Psychiatry, Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia

23 Sep 2024

Author Response
- First, the protocol would benefit from identifying the primary and secondary outcomes. The goals in the abstract are threefold -assessing effectiveness, acceptability, and feasibility. (The article text identifies
... Continue reading
First, the protocol would benefit from identifying the primary and secondary outcomes. The goals in the abstract are threefold -assessing effectiveness, acceptability, and feasibility. (The article text identifies only 2 aims - acceptability and feasibility - although effectiveness is implicitly assumed by the methods). It would be helpful to identify how these goals will be assessed and evaluated as successful or unsuccessful. One primary outcome for effectiveness should be identified. The sample size calculation refers to a standard deviation, but the instrument/variable is unspecified. Answer: The primary outcomes will be GUS, G-SAS, and GRCS. The secondary outcomes will be BIS-11, WHOQOL-BREF, SRQ-20, and URICA. The primary outcome used for sample size calculation is GUS. Feasibility: adherence to the protocol by the participants. Acceptability: 5-point Likert scale for satisfaction after each iCBT session. Effectiveness: measurement of pre- and post- outcomes.

One method of recruitment is approaching current patients in inpatient and outpatient services. Would these patients be receiving treatment for gambling disorder, which seems like an unnecessary confound?
Eligibility includes ICD-11 Gambling Disorder assessed by a psychiatrist. Unfortunately, no standardized instrument exists for assessing these ICD criteria. The lack of an instrument may be problematic for reliably assessing status at follow-up. Perhaps an assessment of DSM-5 Gambling Disorder criteria with a standardized instrument such as the NODS might be more reliable? Will the psychiatrists that provide the treatment also be conducting the follow-up diagnostic assessments?
Answer: All participants will be allowed to continue their prior treatment as indicated. Deleted the post-treatment icd-11 interview as no standardized instruments are available to assess this outcome. Moreover the time duration of the diagnostic criteria (12 months) make it so that it is unreasonable to reassess the participants in 10 weeks.

The analytic plan is briefly described. Repeated measure ANOVA is proposed. Given that there are three time points, a mixed model analyses would better handle missing data. This analytic model would also allow inclusion of a nested “group” variable. It is unclear whether “dropouts” will be followed but they should be included if possible. I agree with Dr. Rodda that the definition of dropout seems arbitrary given that this is a pilot study. Answer: Suggestion accepted, all participants' data will be analyzed whether they finish the study or not.

A minor point is that the discussion describes internet interventions as possibly fostering a sense of anonymity. Given that one of the novel aspects of this intervention is the group sessions, this advantage is unlikely to apply here. Answer: Group therapy design was chosen as this format better supports the purpose of this study: to provide a resource effective means of quality therapy in LMIC and geographically difficult terrains for gambling disorder. We deleted the anonymity benefits in Discussion. In ethical consideration, we mentioned that sharing personal information is forbidden among participants, even after the therapy sessions have concluded.

Thank you for your invaluable feedback.
First, the protocol would benefit from identifying the primary and secondary outcomes. The goals in the abstract are threefold -assessing effectiveness, acceptability, and feasibility. (The article text identifies only 2 aims - acceptability and feasibility - although effectiveness is implicitly assumed by the methods). It would be helpful to identify how these goals will be assessed and evaluated as successful or unsuccessful. One primary outcome for effectiveness should be identified. The sample size calculation refers to a standard deviation, but the instrument/variable is unspecified. Answer: The primary outcomes will be GUS, G-SAS, and GRCS. The secondary outcomes will be BIS-11, WHOQOL-BREF, SRQ-20, and URICA. The primary outcome used for sample size calculation is GUS. Feasibility: adherence to the protocol by the participants. Acceptability: 5-point Likert scale for satisfaction after each iCBT session. Effectiveness: measurement of pre- and post- outcomes.

One method of recruitment is approaching current patients in inpatient and outpatient services. Would these patients be receiving treatment for gambling disorder, which seems like an unnecessary confound?
Eligibility includes ICD-11 Gambling Disorder assessed by a psychiatrist. Unfortunately, no standardized instrument exists for assessing these ICD criteria. The lack of an instrument may be problematic for reliably assessing status at follow-up. Perhaps an assessment of DSM-5 Gambling Disorder criteria with a standardized instrument such as the NODS might be more reliable? Will the psychiatrists that provide the treatment also be conducting the follow-up diagnostic assessments?
Answer: All participants will be allowed to continue their prior treatment as indicated. Deleted the post-treatment icd-11 interview as no standardized instruments are available to assess this outcome. Moreover the time duration of the diagnostic criteria (12 months) make it so that it is unreasonable to reassess the participants in 10 weeks.

The analytic plan is briefly described. Repeated measure ANOVA is proposed. Given that there are three time points, a mixed model analyses would better handle missing data. This analytic model would also allow inclusion of a nested “group” variable. It is unclear whether “dropouts” will be followed but they should be included if possible. I agree with Dr. Rodda that the definition of dropout seems arbitrary given that this is a pilot study. Answer: Suggestion accepted, all participants' data will be analyzed whether they finish the study or not.

A minor point is that the discussion describes internet interventions as possibly fostering a sense of anonymity. Given that one of the novel aspects of this intervention is the group sessions, this advantage is unlikely to apply here. Answer: Group therapy design was chosen as this format better supports the purpose of this study: to provide a resource effective means of quality therapy in LMIC and geographically difficult terrains for gambling disorder. We deleted the anonymity benefits in Discussion. In ethical consideration, we mentioned that sharing personal information is forbidden among participants, even after the therapy sessions have concluded.

Thank you for your invaluable feedback.
Competing Interests: No competing interests were disclosed Close
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COMMENTS ON THIS REPORT

Author Response 23 Sep 2024

Kristiana Siste, Department of Psychiatry, Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia

23 Sep 2024

Author Response
- First, the protocol would benefit from identifying the primary and secondary outcomes. The goals in the abstract are threefold -assessing effectiveness, acceptability, and feasibility. (The article text identifies
... Continue reading
First, the protocol would benefit from identifying the primary and secondary outcomes. The goals in the abstract are threefold -assessing effectiveness, acceptability, and feasibility. (The article text identifies only 2 aims - acceptability and feasibility - although effectiveness is implicitly assumed by the methods). It would be helpful to identify how these goals will be assessed and evaluated as successful or unsuccessful. One primary outcome for effectiveness should be identified. The sample size calculation refers to a standard deviation, but the instrument/variable is unspecified. Answer: The primary outcomes will be GUS, G-SAS, and GRCS. The secondary outcomes will be BIS-11, WHOQOL-BREF, SRQ-20, and URICA. The primary outcome used for sample size calculation is GUS. Feasibility: adherence to the protocol by the participants. Acceptability: 5-point Likert scale for satisfaction after each iCBT session. Effectiveness: measurement of pre- and post- outcomes.

One method of recruitment is approaching current patients in inpatient and outpatient services. Would these patients be receiving treatment for gambling disorder, which seems like an unnecessary confound?
Eligibility includes ICD-11 Gambling Disorder assessed by a psychiatrist. Unfortunately, no standardized instrument exists for assessing these ICD criteria. The lack of an instrument may be problematic for reliably assessing status at follow-up. Perhaps an assessment of DSM-5 Gambling Disorder criteria with a standardized instrument such as the NODS might be more reliable? Will the psychiatrists that provide the treatment also be conducting the follow-up diagnostic assessments?
Answer: All participants will be allowed to continue their prior treatment as indicated. Deleted the post-treatment icd-11 interview as no standardized instruments are available to assess this outcome. Moreover the time duration of the diagnostic criteria (12 months) make it so that it is unreasonable to reassess the participants in 10 weeks.

The analytic plan is briefly described. Repeated measure ANOVA is proposed. Given that there are three time points, a mixed model analyses would better handle missing data. This analytic model would also allow inclusion of a nested “group” variable. It is unclear whether “dropouts” will be followed but they should be included if possible. I agree with Dr. Rodda that the definition of dropout seems arbitrary given that this is a pilot study. Answer: Suggestion accepted, all participants' data will be analyzed whether they finish the study or not.

A minor point is that the discussion describes internet interventions as possibly fostering a sense of anonymity. Given that one of the novel aspects of this intervention is the group sessions, this advantage is unlikely to apply here. Answer: Group therapy design was chosen as this format better supports the purpose of this study: to provide a resource effective means of quality therapy in LMIC and geographically difficult terrains for gambling disorder. We deleted the anonymity benefits in Discussion. In ethical consideration, we mentioned that sharing personal information is forbidden among participants, even after the therapy sessions have concluded.

Thank you for your invaluable feedback.
First, the protocol would benefit from identifying the primary and secondary outcomes. The goals in the abstract are threefold -assessing effectiveness, acceptability, and feasibility. (The article text identifies only 2 aims - acceptability and feasibility - although effectiveness is implicitly assumed by the methods). It would be helpful to identify how these goals will be assessed and evaluated as successful or unsuccessful. One primary outcome for effectiveness should be identified. The sample size calculation refers to a standard deviation, but the instrument/variable is unspecified. Answer: The primary outcomes will be GUS, G-SAS, and GRCS. The secondary outcomes will be BIS-11, WHOQOL-BREF, SRQ-20, and URICA. The primary outcome used for sample size calculation is GUS. Feasibility: adherence to the protocol by the participants. Acceptability: 5-point Likert scale for satisfaction after each iCBT session. Effectiveness: measurement of pre- and post- outcomes.

One method of recruitment is approaching current patients in inpatient and outpatient services. Would these patients be receiving treatment for gambling disorder, which seems like an unnecessary confound?
Eligibility includes ICD-11 Gambling Disorder assessed by a psychiatrist. Unfortunately, no standardized instrument exists for assessing these ICD criteria. The lack of an instrument may be problematic for reliably assessing status at follow-up. Perhaps an assessment of DSM-5 Gambling Disorder criteria with a standardized instrument such as the NODS might be more reliable? Will the psychiatrists that provide the treatment also be conducting the follow-up diagnostic assessments?
Answer: All participants will be allowed to continue their prior treatment as indicated. Deleted the post-treatment icd-11 interview as no standardized instruments are available to assess this outcome. Moreover the time duration of the diagnostic criteria (12 months) make it so that it is unreasonable to reassess the participants in 10 weeks.

The analytic plan is briefly described. Repeated measure ANOVA is proposed. Given that there are three time points, a mixed model analyses would better handle missing data. This analytic model would also allow inclusion of a nested “group” variable. It is unclear whether “dropouts” will be followed but they should be included if possible. I agree with Dr. Rodda that the definition of dropout seems arbitrary given that this is a pilot study. Answer: Suggestion accepted, all participants' data will be analyzed whether they finish the study or not.

A minor point is that the discussion describes internet interventions as possibly fostering a sense of anonymity. Given that one of the novel aspects of this intervention is the group sessions, this advantage is unlikely to apply here. Answer: Group therapy design was chosen as this format better supports the purpose of this study: to provide a resource effective means of quality therapy in LMIC and geographically difficult terrains for gambling disorder. We deleted the anonymity benefits in Discussion. In ethical consideration, we mentioned that sharing personal information is forbidden among participants, even after the therapy sessions have concluded.

Thank you for your invaluable feedback.
Competing Interests: No competing interests were disclosed Close
Report a concern

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Reviewer Report 30 Aug 2024

Simone N Rodda, Department of Psychology and Neuroscience, Auckland University of Technology, Auckland, Auckland, New Zealand

Approved with Reservations

https://doi.org/10.5256/f1000research.165628.r300646

Thank you for the opportunity to review this protocol for iCBT for an Indonesian cohort of people with Gambling Disorder. An interesting study and well-written protocol. Some minor points of clarification are listed below.
Citations 13-15 are individual studies on help-seeking, but this is superseded by a meta-analysis on population prevalence studies from around the world which reported one in five people with problem gambling had sought treatment and one in 25 at moderate risk, so the suggestion that it is 10% is not entirely correct. See (Bijker R,et al., 2022 [Ref 1])
Methods
Figure 1 refers to ‘groups of 5’ under treatment, suggesting the treatment is group-based, which so far hasn't been stated. Figure 2 also refers to groups – but there’s nothing in the text on it until well into the methods under delivering the intervention.
The delivery section suggests in-person treatment, but this is not reported anywhere earlier in the introduction or aims. It is also discussed that it is group therapy with iCBT consisting of videos and activities. This is really interesting and novel but hasn’t been stated in the background, aims, or study design. I’m not sure I know of other treatments that blend in-person with iCBT – so really novel – and if not, then the previous studies should be reported. I note under sample size it is referred to as group therapy – if so, what BCTs are being delivered then and how does this relate to the iCBT content?

It would be great to have a table of the specific BCTs being delivered, when and how frequently, and how they are being delivered (therapist, video, written, other) and then link that to the outcome measures. For instance, I see an outcome measure of impulsivity, and it would be good to know exactly which BCT is expected to change that variable, etc. I don’t think Table 2 is sufficient for replication or to be able to map intervention components to outcomes. TREND reporting guidelines state that sufficient intervention information should be provided so as to allow for replication.

I wonder, given the intervention is exploratory, whether it is appropriate to describe participants who do not complete the entire 10 weeks as drop-out? Perhaps an alternative is to use the feasibility study as a way of determining the optimal duration/configuration of the iCBT. Looking later at the manuscript, it looks like drop-out is from in-person treatment rather than the iCBT?

Given the ICD-11 is being used in the interview, I wonder if it is necessary to burden participants with the SOGS given it is screening only. Perhaps consider a briefer screen – there are meta-analyses on brief screens to detect GD.

Discussion
Given that gambling is illegal, perhaps there needs to be a stronger case made for group therapy, which by its very nature sounds problematic for anonymity, legal and criminal issues, and chances of sharing gambling information.

The discussion again refers to the treatment being delivered online. It would be good to be very clear on who is delivering what behaviour change technique and how (see Michie work on BCTs if not familiar).

Minor Instead of ‘pathological gambler’ – consider person with pathological gambling or similar.

Is the rationale for, and objectives of, the study clearly described?

Yes
Is the study design appropriate for the research question?

Yes
Are sufficient details of the methods provided to allow replication by others?

Yes
Are the datasets clearly presented in a useable and accessible format?

Not applicable

References

1. Bijker R, Booth N, Merkouris SS, Dowling NA, et al.: Global prevalence of help-seeking for problem gambling: A systematic review and meta-analysis.Addiction. 2022; 117 (12): 2972-2985 PubMed Abstract | Publisher Full Text

Competing Interests: No competing interests were disclosed.

Reviewer Expertise: Internet delivered interventions, help seeking and gambling disorder.

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Author Response 23 Sep 2024

Kristiana Siste, Department of Psychiatry, Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia

23 Sep 2024

Author Response
- Citations 13-15 are individual studies on help-seeking, but this is superseded by a meta-analysis on population prevalence studies from around the world which reported one in five people
... Continue reading
Citations 13-15 are individual studies on help-seeking, but this is superseded by a meta-analysis on population prevalence studies from around the world which reported one in five people with problem gambling had sought treatment and one in 25 at moderate risk, so the suggestion that it is 10% is not entirely correct. See (Bijker R,et al., 2022 [Ref 1]).

Answer: We have revised the number of treatment-seeking gamblers according to Bijker R et al., 2022 in the last paragraph of the Introduction.

Figure 1 refers to ‘groups of 5’ under treatment, suggesting the treatment is group-based, which so far hasn't been stated. Figure 2 also refers to groups – but there’s nothing in the text on it until well into the methods under delivering the intervention.

Answer: We added the suggestion in the paragraph above figure 1.

The delivery section suggests in-person treatment, but this is not reported anywhere earlier in the introduction or aims.

Answer: We added the suggestion in the study design section.

It is also discussed that it is group therapy with iCBT consisting of videos and activities. This is really interesting and novel but hasn’t been stated in the background, aims, or study design.

Answer: The treatment will consist of individual online learning sessions delivered through pre-recorded videos, followed by weekly online group therapy sessions with a therapist. Each group therapy session will include five participants and will occur over a 10-week period.

It would be great to have a table of the specific BCTs being delivered, when and how frequently, and how they are being delivered (therapist, video, written, other) and then link that to the outcome measures. For instance, I see an outcome measure of impulsivity, and it would be good to know exactly which BCT is expected to change that variable, etc.

Answer: We have now specified them in Table 2.

Given the intervention is exploratory, whether it is appropriate to describe participants who do not complete the entire 10 weeks as drop-out? Perhaps an alternative is to use the feasibility study as a way of determining the optimal duration/configuration of the iCBT. Looking later at the manuscript, it looks like drop-out is from in-person treatment rather than the iCBT?

Answer: There will be no drop out criteria in this study. Adherence to the treatment will be evaluated to optimize the configuration of the iCBT for future studies.

Given the ICD-11 is being used in the interview, I wonder if it is necessary to burden participants with the SOGS given it is screening only. Perhaps consider a briefer screen – there are meta-analyses on brief screens to detect GD.

Answer: We will be using SOGS as it is validated and proven reliable in Bahasa Indonesia.

Given that gambling is illegal, perhaps there needs to be a stronger case made for group therapy, which by its very nature sounds problematic for anonymity, legal and criminal issues, and chances of sharing gambling information.

Answer: Group therapy design was chosen as this format better supports the purpose of this study: to provide a resource effective means of quality therapy in LMIC and geographically difficult terrains for gambling disorder. We deleted the anonymity benefits in Discussion. In ethical consideration, we mentioned that sharing personal information is forbidden among participants, even after the therapy sessions have concluded.

The discussion again refers to the treatment being delivered online. It would be good to be very clear on who is delivering what behaviour change technique and how (see Michie work on BCTs if not familiar).

Answer: Specified in Table 2.

Instead of ‘pathological gambler’ – consider person with pathological gambling or similar.

Answer: We added the suggestion, except for “probable pathological gambler” classification in SOGS.
Citations 13-15 are individual studies on help-seeking, but this is superseded by a meta-analysis on population prevalence studies from around the world which reported one in five people with problem gambling had sought treatment and one in 25 at moderate risk, so the suggestion that it is 10% is not entirely correct. See (Bijker R,et al., 2022 [Ref 1]).

Answer: We have revised the number of treatment-seeking gamblers according to Bijker R et al., 2022 in the last paragraph of the Introduction.

Figure 1 refers to ‘groups of 5’ under treatment, suggesting the treatment is group-based, which so far hasn't been stated. Figure 2 also refers to groups – but there’s nothing in the text on it until well into the methods under delivering the intervention.

Answer: We added the suggestion in the paragraph above figure 1.

The delivery section suggests in-person treatment, but this is not reported anywhere earlier in the introduction or aims.

Answer: We added the suggestion in the study design section.

It is also discussed that it is group therapy with iCBT consisting of videos and activities. This is really interesting and novel but hasn’t been stated in the background, aims, or study design.

Answer: The treatment will consist of individual online learning sessions delivered through pre-recorded videos, followed by weekly online group therapy sessions with a therapist. Each group therapy session will include five participants and will occur over a 10-week period.

It would be great to have a table of the specific BCTs being delivered, when and how frequently, and how they are being delivered (therapist, video, written, other) and then link that to the outcome measures. For instance, I see an outcome measure of impulsivity, and it would be good to know exactly which BCT is expected to change that variable, etc.

Answer: We have now specified them in Table 2.

Given the intervention is exploratory, whether it is appropriate to describe participants who do not complete the entire 10 weeks as drop-out? Perhaps an alternative is to use the feasibility study as a way of determining the optimal duration/configuration of the iCBT. Looking later at the manuscript, it looks like drop-out is from in-person treatment rather than the iCBT?

Answer: There will be no drop out criteria in this study. Adherence to the treatment will be evaluated to optimize the configuration of the iCBT for future studies.

Given the ICD-11 is being used in the interview, I wonder if it is necessary to burden participants with the SOGS given it is screening only. Perhaps consider a briefer screen – there are meta-analyses on brief screens to detect GD.

Answer: We will be using SOGS as it is validated and proven reliable in Bahasa Indonesia.

Given that gambling is illegal, perhaps there needs to be a stronger case made for group therapy, which by its very nature sounds problematic for anonymity, legal and criminal issues, and chances of sharing gambling information.

Answer: Group therapy design was chosen as this format better supports the purpose of this study: to provide a resource effective means of quality therapy in LMIC and geographically difficult terrains for gambling disorder. We deleted the anonymity benefits in Discussion. In ethical consideration, we mentioned that sharing personal information is forbidden among participants, even after the therapy sessions have concluded.

The discussion again refers to the treatment being delivered online. It would be good to be very clear on who is delivering what behaviour change technique and how (see Michie work on BCTs if not familiar).

Answer: Specified in Table 2.

Instead of ‘pathological gambler’ – consider person with pathological gambling or similar.

Answer: We added the suggestion, except for “probable pathological gambler” classification in SOGS.
Competing Interests: No competing interests were disclosed. Close
Report a concern
Respond or Comment

COMMENTS ON THIS REPORT

Author Response 23 Sep 2024

Kristiana Siste, Department of Psychiatry, Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia

23 Sep 2024

Author Response
- Citations 13-15 are individual studies on help-seeking, but this is superseded by a meta-analysis on population prevalence studies from around the world which reported one in five people
... Continue reading
Citations 13-15 are individual studies on help-seeking, but this is superseded by a meta-analysis on population prevalence studies from around the world which reported one in five people with problem gambling had sought treatment and one in 25 at moderate risk, so the suggestion that it is 10% is not entirely correct. See (Bijker R,et al., 2022 [Ref 1]).

Answer: We have revised the number of treatment-seeking gamblers according to Bijker R et al., 2022 in the last paragraph of the Introduction.

Figure 1 refers to ‘groups of 5’ under treatment, suggesting the treatment is group-based, which so far hasn't been stated. Figure 2 also refers to groups – but there’s nothing in the text on it until well into the methods under delivering the intervention.

Answer: We added the suggestion in the paragraph above figure 1.

The delivery section suggests in-person treatment, but this is not reported anywhere earlier in the introduction or aims.

Answer: We added the suggestion in the study design section.

It is also discussed that it is group therapy with iCBT consisting of videos and activities. This is really interesting and novel but hasn’t been stated in the background, aims, or study design.

Answer: The treatment will consist of individual online learning sessions delivered through pre-recorded videos, followed by weekly online group therapy sessions with a therapist. Each group therapy session will include five participants and will occur over a 10-week period.

It would be great to have a table of the specific BCTs being delivered, when and how frequently, and how they are being delivered (therapist, video, written, other) and then link that to the outcome measures. For instance, I see an outcome measure of impulsivity, and it would be good to know exactly which BCT is expected to change that variable, etc.

Answer: We have now specified them in Table 2.

Given the intervention is exploratory, whether it is appropriate to describe participants who do not complete the entire 10 weeks as drop-out? Perhaps an alternative is to use the feasibility study as a way of determining the optimal duration/configuration of the iCBT. Looking later at the manuscript, it looks like drop-out is from in-person treatment rather than the iCBT?

Answer: There will be no drop out criteria in this study. Adherence to the treatment will be evaluated to optimize the configuration of the iCBT for future studies.

Given the ICD-11 is being used in the interview, I wonder if it is necessary to burden participants with the SOGS given it is screening only. Perhaps consider a briefer screen – there are meta-analyses on brief screens to detect GD.

Answer: We will be using SOGS as it is validated and proven reliable in Bahasa Indonesia.

Given that gambling is illegal, perhaps there needs to be a stronger case made for group therapy, which by its very nature sounds problematic for anonymity, legal and criminal issues, and chances of sharing gambling information.

Answer: Group therapy design was chosen as this format better supports the purpose of this study: to provide a resource effective means of quality therapy in LMIC and geographically difficult terrains for gambling disorder. We deleted the anonymity benefits in Discussion. In ethical consideration, we mentioned that sharing personal information is forbidden among participants, even after the therapy sessions have concluded.

The discussion again refers to the treatment being delivered online. It would be good to be very clear on who is delivering what behaviour change technique and how (see Michie work on BCTs if not familiar).

Answer: Specified in Table 2.

Instead of ‘pathological gambler’ – consider person with pathological gambling or similar.

Answer: We added the suggestion, except for “probable pathological gambler” classification in SOGS.
Citations 13-15 are individual studies on help-seeking, but this is superseded by a meta-analysis on population prevalence studies from around the world which reported one in five people with problem gambling had sought treatment and one in 25 at moderate risk, so the suggestion that it is 10% is not entirely correct. See (Bijker R,et al., 2022 [Ref 1]).

Answer: We have revised the number of treatment-seeking gamblers according to Bijker R et al., 2022 in the last paragraph of the Introduction.

Figure 1 refers to ‘groups of 5’ under treatment, suggesting the treatment is group-based, which so far hasn't been stated. Figure 2 also refers to groups – but there’s nothing in the text on it until well into the methods under delivering the intervention.

Answer: We added the suggestion in the paragraph above figure 1.

The delivery section suggests in-person treatment, but this is not reported anywhere earlier in the introduction or aims.

Answer: We added the suggestion in the study design section.

It is also discussed that it is group therapy with iCBT consisting of videos and activities. This is really interesting and novel but hasn’t been stated in the background, aims, or study design.

Answer: The treatment will consist of individual online learning sessions delivered through pre-recorded videos, followed by weekly online group therapy sessions with a therapist. Each group therapy session will include five participants and will occur over a 10-week period.

It would be great to have a table of the specific BCTs being delivered, when and how frequently, and how they are being delivered (therapist, video, written, other) and then link that to the outcome measures. For instance, I see an outcome measure of impulsivity, and it would be good to know exactly which BCT is expected to change that variable, etc.

Answer: We have now specified them in Table 2.

Given the intervention is exploratory, whether it is appropriate to describe participants who do not complete the entire 10 weeks as drop-out? Perhaps an alternative is to use the feasibility study as a way of determining the optimal duration/configuration of the iCBT. Looking later at the manuscript, it looks like drop-out is from in-person treatment rather than the iCBT?

Answer: There will be no drop out criteria in this study. Adherence to the treatment will be evaluated to optimize the configuration of the iCBT for future studies.

Given the ICD-11 is being used in the interview, I wonder if it is necessary to burden participants with the SOGS given it is screening only. Perhaps consider a briefer screen – there are meta-analyses on brief screens to detect GD.

Answer: We will be using SOGS as it is validated and proven reliable in Bahasa Indonesia.

Given that gambling is illegal, perhaps there needs to be a stronger case made for group therapy, which by its very nature sounds problematic for anonymity, legal and criminal issues, and chances of sharing gambling information.

Answer: Group therapy design was chosen as this format better supports the purpose of this study: to provide a resource effective means of quality therapy in LMIC and geographically difficult terrains for gambling disorder. We deleted the anonymity benefits in Discussion. In ethical consideration, we mentioned that sharing personal information is forbidden among participants, even after the therapy sessions have concluded.

The discussion again refers to the treatment being delivered online. It would be good to be very clear on who is delivering what behaviour change technique and how (see Michie work on BCTs if not familiar).

Answer: Specified in Table 2.

Instead of ‘pathological gambler’ – consider person with pathological gambling or similar.

Answer: We added the suggestion, except for “probable pathological gambler” classification in SOGS.
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Simone N Rodda, Auckland University of Technology, Auckland, New Zealand
David C Hodgins, University of Calgary, Calgary, Canada

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14 Oct 2024 | for Version 2

Simone N Rodda, Department of Psychology and Neuroscience, Auckland University of Technology, Auckland, Auckland, New Zealand

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Approved

Thank you for addressing my comments. Article looks great. Perhaps consider being clear on the primary outcomes in the abstract and remove the secondary/exploratory items.
Good luck with the research.

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

Internet delivered interventions, help seeking and gambling disorder.

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard.

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28 Sep 2024 | for Version 2

David C Hodgins, University of Calgary, Calgary, Alberta, Canada

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Approved

No further comments. Suggestions have been clearly addressed.

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Reviewer Expertise

Gambling disorders, including intervention.

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard.

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06 Sep 2024 | for Version 1

David C Hodgins, University of Calgary, Calgary, Alberta, Canada

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Approved With Reservations

Is the rationale for, and objectives of, the study clearly described?

Yes
Is the study design appropriate for the research question?

Yes
Are sufficient details of the methods provided to allow replication by others?

Yes
Are the datasets clearly presented in a useable and accessible format?

Not applicable

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

Gambling disorders, including intervention.

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23 Sep 2024

Kristiana Siste, Department of Psychiatry, Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia

First, the protocol would benefit from identifying the primary and secondary outcomes. The goals in the abstract are threefold -assessing effectiveness, acceptability, and feasibility. (The article text identifies only 2 aims - acceptability and feasibility - although effectiveness is implicitly assumed by the methods). It would be helpful to identify how these goals will be assessed and evaluated as successful or unsuccessful. One primary outcome for effectiveness should be identified. The sample size calculation refers to a standard deviation, but the instrument/variable is unspecified. Answer: The primary outcomes will be GUS, G-SAS, and GRCS. The secondary outcomes will be BIS-11, WHOQOL-BREF, SRQ-20, and URICA. The primary outcome used for sample size calculation is GUS. Feasibility: adherence to the protocol by the participants. Acceptability: 5-point Likert scale for satisfaction after each iCBT session. Effectiveness: measurement of pre- and post- outcomes.
One method of recruitment is approaching current patients in inpatient and outpatient services. Would these patients be receiving treatment for gambling disorder, which seems like an unnecessary confound?
Eligibility includes ICD-11 Gambling Disorder assessed by a psychiatrist. Unfortunately, no standardized instrument exists for assessing these ICD criteria. The lack of an instrument may be problematic for reliably assessing status at follow-up. Perhaps an assessment of DSM-5 Gambling Disorder criteria with a standardized instrument such as the NODS might be more reliable? Will the psychiatrists that provide the treatment also be conducting the follow-up diagnostic assessments?
Answer: All participants will be allowed to continue their prior treatment as indicated. Deleted the post-treatment icd-11 interview as no standardized instruments are available to assess this outcome. Moreover the time duration of the diagnostic criteria (12 months) make it so that it is unreasonable to reassess the participants in 10 weeks.
The analytic plan is briefly described. Repeated measure ANOVA is proposed. Given that there are three time points, a mixed model analyses would better handle missing data. This analytic model would also allow inclusion of a nested “group” variable. It is unclear whether “dropouts” will be followed but they should be included if possible. I agree with Dr. Rodda that the definition of dropout seems arbitrary given that this is a pilot study. Answer: Suggestion accepted, all participants' data will be analyzed whether they finish the study or not.
A minor point is that the discussion describes internet interventions as possibly fostering a sense of anonymity. Given that one of the novel aspects of this intervention is the group sessions, this advantage is unlikely to apply here. Answer: Group therapy design was chosen as this format better supports the purpose of this study: to provide a resource effective means of quality therapy in LMIC and geographically difficult terrains for gambling disorder. We deleted the anonymity benefits in Discussion. In ethical consideration, we mentioned that sharing personal information is forbidden among participants, even after the therapy sessions have concluded.

Thank you for your invaluable feedback.

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30 Aug 2024 | for Version 1

Simone N Rodda, Department of Psychology and Neuroscience, Auckland University of Technology, Auckland, Auckland, New Zealand

12 Views Cite this report Responses(1)

Approved With Reservations

Is the rationale for, and objectives of, the study clearly described?

Yes
Is the study design appropriate for the research question?

Yes
Are sufficient details of the methods provided to allow replication by others?

Yes
Are the datasets clearly presented in a useable and accessible format?

Not applicable

References

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

Internet delivered interventions, help seeking and gambling disorder.

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Author Response

23 Sep 2024

Kristiana Siste, Department of Psychiatry, Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia

Citations 13-15 are individual studies on help-seeking, but this is superseded by a meta-analysis on population prevalence studies from around the world which reported one in five people with problem gambling had sought treatment and one in 25 at moderate risk, so the suggestion that it is 10% is not entirely correct. See (Bijker R,et al., 2022 [Ref 1]).

Answer: We have revised the number of treatment-seeking gamblers according to Bijker R et al., 2022 in the last paragraph of the Introduction.

Figure 1 refers to ‘groups of 5’ under treatment, suggesting the treatment is group-based, which so far hasn't been stated. Figure 2 also refers to groups – but there’s nothing in the text on it until well into the methods under delivering the intervention.

Answer: We added the suggestion in the paragraph above figure 1.

The delivery section suggests in-person treatment, but this is not reported anywhere earlier in the introduction or aims.

Answer: We added the suggestion in the study design section.

It is also discussed that it is group therapy with iCBT consisting of videos and activities. This is really interesting and novel but hasn’t been stated in the background, aims, or study design.

Answer: The treatment will consist of individual online learning sessions delivered through pre-recorded videos, followed by weekly online group therapy sessions with a therapist. Each group therapy session will include five participants and will occur over a 10-week period.

It would be great to have a table of the specific BCTs being delivered, when and how frequently, and how they are being delivered (therapist, video, written, other) and then link that to the outcome measures. For instance, I see an outcome measure of impulsivity, and it would be good to know exactly which BCT is expected to change that variable, etc.

Answer: We have now specified them in Table 2.

Given the intervention is exploratory, whether it is appropriate to describe participants who do not complete the entire 10 weeks as drop-out? Perhaps an alternative is to use the feasibility study as a way of determining the optimal duration/configuration of the iCBT. Looking later at the manuscript, it looks like drop-out is from in-person treatment rather than the iCBT?

Answer: There will be no drop out criteria in this study. Adherence to the treatment will be evaluated to optimize the configuration of the iCBT for future studies.

Given the ICD-11 is being used in the interview, I wonder if it is necessary to burden participants with the SOGS given it is screening only. Perhaps consider a briefer screen – there are meta-analyses on brief screens to detect GD.

Answer: We will be using SOGS as it is validated and proven reliable in Bahasa Indonesia.

Given that gambling is illegal, perhaps there needs to be a stronger case made for group therapy, which by its very nature sounds problematic for anonymity, legal and criminal issues, and chances of sharing gambling information.

Answer: Group therapy design was chosen as this format better supports the purpose of this study: to provide a resource effective means of quality therapy in LMIC and geographically difficult terrains for gambling disorder. We deleted the anonymity benefits in Discussion. In ethical consideration, we mentioned that sharing personal information is forbidden among participants, even after the therapy sessions have concluded.

The discussion again refers to the treatment being delivered online. It would be good to be very clear on who is delivering what behaviour change technique and how (see Michie work on BCTs if not familiar).

Answer: Specified in Table 2.

Instead of ‘pathological gambler’ – consider person with pathological gambling or similar.

Answer: We added the suggestion, except for “probable pathological gambler” classification in SOGS.

View more View less

Competing Interests

No competing interests were disclosed.

Alongside their report, reviewers assign a status to the article:

Approved - the paper is scientifically sound in its current form and only minor, if any, improvements are suggested

Approved with reservations - A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit.

Not approved - fundamental flaws in the paper seriously undermine the findings and conclusions

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Internet-based cognitive behavioral therapy for individuals with gambling disorder in Indonesia: protocol for a pilot and feasibility study

Abstract

Background

Methods

Discussion

Keywords

Revised Amendments from Version 1

Introduction

Methods

Study design

Figure 1. Study flowchart.

Participants and settings

Table 1. Outcome and measurement.

Figure 2. Study timeline.

Development of the iCBT

Table 2. Description of iCBT module content.

Delivering the intervention

Providers of iCBT

Participant characteristics

Sample size

Statistical analysis

Data monitoring

Study status

Dissemination

Discussion

Ethical consideration

Contributors

Ethics and dissemination

Trial Registration

Data availability

Underlying data

Reporting guideline

Acknowledgements

References

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