The Southampton Adaptation Framework (SAF) is a structured approach developed by Naeem et al. (one of the co-authors of this study) to guide the cultural adaptation of CBT for use in non-Western contexts. ³⁸ The SAF emphasizes the importance of considering cultural and religious factors in mental health interventions to ensure their relevance and effectiveness in diverse cultural settings. ³⁸ The framework comprises three core themes: “awareness of culture and religion,” “assessment and engagement,” and “adjustment in therapy,” each with several subthemes. ³⁸ SAF has been utilized by several studies to develop different psychosocial interventions for a variety of mental health conditions. ³⁸ Interventions such as CBT, ^{39– 41} Dialectical Behaviour Therapy (DBT), ⁴² family-based interventions, ⁴³ and others like learning through play, psychoeducation, and problem-solving interventions ³⁸ have been developed using SAF, for conditions including depression, ⁴⁴ psychosis, ^{40, 45} schizophrenia, ⁴³ obsessive-compulsive disorders, post-traumatic stress disorders, suicidal ideation, schizophrenia, and self-harm. ³⁸

The SAF facilitates the cultural adaptation of CBT interventions, promoting effectiveness and acceptability in diverse cultural settings. By integrating cultural awareness and sensitivity into the adaptation process, mental health professionals can provide inclusive and responsive care that meets the needs of individuals from various cultural backgrounds. ³⁸

The sample size for this qualitative study will be determined using both saturation and information power. Saturation refers to the point at which no new themes or insights emerge from additional interviews, ⁴⁶ while information power is a prospective approach that considers study aim, sample specificity, theoretical grounding, dialogue quality, and analysis strategy to determine an adequate sample size. ⁴⁷ The study will initially set the sample size based on information power, given its specific focus on the cultural aspects of cannabis use and treatment. Data collection will continue until saturation is achieved. Two FGDs, each with six to eight participants and at least 15 IDIs, will be conducted.

Participants will be recruited through purposive and snowball sampling to ensure representation from key stakeholder groups. Healthcare professionals will identify individuals with CUD and their caregivers. Efforts will be made to include individuals of diverse ages, socioeconomic backgrounds, education levels, and geographic locations. Patients with CUD and their family members will participate in FGDs and IDIs, while mental health professionals, local leaders, and religious scholars will provide additional perspectives through IDIs only. Mental health professionals will include psychiatrists and psychologists working in tertiary care hospitals. Religious scholars will offer insights into faith-based views on cannabis use and treatment. Locally elected leaders will provide their perspectives on community policies and social attitudes concerning cannabis use. Written informed consent will be obtained from all adult participants prior to their inclusion in the study. Study information will be provided as detailed in Annexure B (Supplementary document 1), and written consent will be documented using the form in Annexure C (Supplementary document 1).

Participants must be 18 years or older and residents of Peshawar. CUD users must have a confirmed diagnosis of CUD using the Cannabis Use Disorder Identification Test (CUDIT), prior cannabis use, or experience supporting individuals with CUD. Mental health professionals must have experience in treating substance use disorders. Religious leaders must be actively delivering sermons in community mosques, and local leaders must hold an elected position. Individuals who are not Pakistani nationals, healthcare professionals working exclusively in private clinics, religious leaders residing outside Peshawar, or former local leaders no longer in office will be excluded. Family members no longer in contact with the patient will also be ineligible to participate.

FGDs will take place in community settings such as the “Hujra,” a traditional gathering place for discussions, with locations finalized in consultation with participants. IDIs will be conducted in locations preferred by participants to ensure privacy.

Participants will voluntarily decide whether to join the study. An information sheet in Urdu will outline the study’s purpose, potential benefits and risks, audio recording details, payments, confidentiality, withdrawal rights, and researcher contact information. Participants will receive the sheet in advance and will have the opportunity to ask questions. Before participation, they will be given a written consent form in Urdu, and any concerns will be addressed. Only those who fully understand the study and provide informed consent will participate. Incomplete or unsigned forms will indicate non-consent (Supplementary document 1).

The interview process will be conducted by the researcher and a note-taker will be present to document the process. Participants will be contacted in advance to receive the information sheet, provide consent, and schedule interviews. All necessary materials, including a voice recorder, notepads, and pens, will be arranged beforehand. Availability will be confirmed before each session, and upon arrival, the researchers will introduce themselves and build rapport with participants. FGDs will begin once all participants are present, following a structured discussion guide. The note-taker will document key points, and recordings will be securely saved. FGDs will last 60–90 minutes, while IDIs will take 30–45 minutes.

The topic guides for FGDs and IDIs are based on the SAF framework and previous work on culturally adapting CBT. ¹⁷ These are tailored to cannabis use, participant type, and interview method, ensuring alignment with the study’s theoretical framework. The guides include open-ended and semi-structured questions with relevant probes, translated into Urdu and reviewed by a qualitative expert (Supplementary document 1).

Data from qualitative interviews will be subjected to framework analysis, ⁴⁸ ensuring a structured identification of key cultural themes. Transcriptions of recorded interviews will be translated into English while maintaining the integrity of cultural idioms and expressions. Data analysis will follow a deductive approach utilizing the pre-established Southampton Adaptation Framework while allowing for inductive insights if new themes emerge. NVivo (version 14) software will be used to code and manage qualitative data to ensure consistency and reliability. A codebook will be developed to define each thematic category operationally and undergo expert review to ensure accuracy. Inter-coder reliability will be assessed using Cohen’s kappa coefficient, with a threshold of 0.80 considered an indicator of excellent agreement. Triangulation of data from IDIs and FGDs will enhance the reliability of findings, offering a comprehensive understanding of the cultural factors influencing CBT adaptation for CUD patients in Peshawar.

Co-adaptation workshops will be conducted in three separate sessions lasting two to three hours each, and will be held at 15-day intervals, following a participatory action research (PAR) approach. ⁴⁹ This approach will ensure that key stakeholders actively contribute to modifying and refining CBT techniques in a culturally sensitive manner.

A co-production group of approx. 12 participants will be established to ensure a multidisciplinary perspective in guiding the adaptation process. This group will include two individuals currently using cannabis, two individuals who have successfully quit, two caregivers supporting patients with CUD, two therapists experienced in addiction treatment, and two researchers specializing in psychological interventions. Additionally, one local leader and one religious scholar will contribute to ensure that the intervention reflects broader cultural and societal perspectives. Participants will be identified through hospital networks, therapist referrals, and community outreach programs. Written informed consent will be obtained from all group members prior to participation. An information sheet will be provided before enrolment, and sufficient time will be given for participants to consider their decision.

The workshops will be conducted at Khyber Medical University (KMU), which provides an academic and professional environment conducive to research collaboration. The adaptation process will integrate findings from the systematic review and qualitative interviews, ensuring that the intervention remains evidence-based while being aligned with local beliefs and treatment practices. The workshops will incorporate discussions on culturally relevant treatment strategies, language preferences, and social perceptions of cannabis use and recovery. Each session will include structured discussions, hands-on adaptation of CBT components, and review of previously discussed modifications. The staggered schedule will allow sufficient time between sessions for participants to reflect on discussions and for preliminary refinements to be incorporated before the next session. Discussions will focus on how therapeutic concepts can be conveyed in a culturally meaningful way, ensuring that local idioms of distress, community support mechanisms, and social norms are considered in the adapted intervention. Audio recordings of discussions will be maintained for accuracy, while detailed field notes will be taken to document emerging themes and key recommendations.

The eligibility criteria for participation in the co-adaptation workshops will align with those established in the first phase. Participants must be 18 years or older, have prior experience related to CUD either as a patient, caregiver, or professional, and be willing to participate in all three workshop sessions. Healthcare providers and researchers must have relevant clinical or academic experience in addiction treatment or psychological interventions. Religious leaders must be active sermon deliverers in mosques, and local leaders must hold an elected position.

Participants will receive comprehensive information about the purpose, objectives, and structure of the workshops. Invitations will be sent via email, formal letters from KMU, and WhatsApp messages at least one month before the workshops, with follow-up reminders sent 15 days and one week before each session. Before participation, individuals will have an opportunity to ask questions and clarify any concerns. Written informed consent will be obtained from all participants prior to their involvement (Supplementary document 1).

The workshops will be moderated by the researcher along with a note-taker. Audio recordings will capture detailed stakeholder discussions, while research team members will take extensive field notes. Participant feedback forms will be used to gather insights on the perceived acceptability, feasibility, and clarity of the adapted CBT intervention. These data sources will support an iterative refinement process, allowing for continuous modification and improvement of the intervention based on participant feedback.

Topic guides will be developed to facilitate discussions during the workshops. These guides will be informed by multiple sources, including the original CBT manual, findings from qualitative interviews and focus group discussions, and insights from the systematic review. The guides will address key areas such as local perceptions of cannabis use, barriers to treatment engagement, culturally resonant coping strategies, and the integration of religious and community-based support systems.

Thematic analysis will be conducted to analyze data from the co-adaptation workshops (ref ). Audio recordings will be transcribed verbatim, and field notes will be systematically reviewed. The analysis will follow a structured coding framework, beginning with an initial coding phase to identify prominent themes and patterns. These themes will be further refined through iterative discussions among the research team, with key findings categorized into conceptual areas such as cultural adaptation, treatment acceptability, and feasibility of implementation. A triangulation approach will be used, integrating feedback from different stakeholder groups to ensure a balanced and comprehensive adaptation process. The findings from this analysis will directly inform revisions to the CBT manual, ensuring that the intervention remains both scientifically grounded and culturally relevant. The finalized adaptation will undergo further review by experts and stakeholders before proceeding to the feasibility study in the next phase.

A pre-post study will be conducted. Patients with CUD will be provided with CA-CBT intervention and assessed for the desired outcomes. The goal is to gain a deeper understanding of how CA-CBT is experienced in real-world settings and to seek guidance from the study for conducting pilot feasibility and/or definitive trial.

The study will be conducted in three government tertiary care hospitals in Peshawar. There are three functional government tertiary care hospitals in Peshawar: Lady Reading Hospital (LRH), Khyber Teaching Hospital (KTH), and Hayatabad Medical Complex (HMC). These tertiary care hospitals are being chosen purposively based on having a specialized psychiatry unit providing drug abuse rehabilitation services. Permission will be obtained from the hospitals for the study’s implementation.

Patients aged 18 years or older who present at the facility will be assessed using the CUDIT. Those who score more than 12 on the CUDIT will be considered patients with CUD and included in the study. Additionally, patients who self-confirm current cannabis use will be assessed on CUDIT, and after confirmation of a score above 12, will be included. Similarly, psychiatrists/psychologists who are engaged in treating patients with CUD in these tertiary care hospitals will be included in this study.

Patients will be excluded from the study if they have a physical or mental impairment that hinders their ability to provide informed consent, are currently on psychotic drugs or receiving medications for drug addiction, are currently suicidal as defined in the Mental Health Gap Action Programme (mhGAP) intervention Guide ⁵⁰ or have made a suicidal attempt within the past two years. Pregnant women will be excluded from this study and will not receive CA-CBT.

Participants will be identified and recruited with the help of hospital staff and psychiatrists working in tertiary care hospitals. Patients seeking treatment for cannabis use will be screened for eligibility based on inclusion and exclusion criteria and included in the study after obtaining written informed consent. Patients having difficulty in reading or writing will be informed, and verbal consent will be taken from them in the presence of a witness. The witness will not be a part of the research team or hospital staff (Supplementary document 1).

Sample size was estimated using a traffic light progression framework to inform decisions on advancing to a full trial. This framework incorporated a green lower limit indicating thresholds for progression, a red upper limit suggesting discontinuation, and an intermediate amber range where progression may be considered with adjustments. ⁵¹ A normal approximation method was applied, with alpha set at 0.05 and beta at 0.2. A single-arm allocation was considered, and expected recruitment was set at 40%. Progression criteria specified a green lower limit of 0.50 for eligibility and 0.75 for retention, acceptability, appropriateness, and feasibility. Red upper limits were set at 0.20 for recruitment and eligibility, and 0.50 for the remaining feasibility outcomes. Based on these parameters, the required number of patients to be assessed was 68 at the population level. The required number of patients to receive the intervention was 27. The sample size was considered sufficient to detect feasibility indicators exceeding the red thresholds with a statistical power of at least 80%. Thus, a total of 27 patients will be recruited across three sites, with nine patients enrolled per site. The findings are expected to inform the design of a larger, more definitive trial in the future. At each study site, one therapist will be trained (three therapists in total) to deliver CA-CBT. These therapists will be purposively selected, having previous experience in treating drug abuse patients. Patients will be conveniently selected based on the eligibility criteria ( Figure 2).

Three psychologists currently working in the mental health and drug abuse departments of tertiary care hospitals will receive training (six days, as per the identified manual). These psychologists are directly involved in providing services to patients dealing with drug abuse, making them ideal candidates for implementing the CA-CBT intervention. The training will cover various aspects of CA-CBT, including its theoretical foundations, practical application, and specific techniques tailored for treating patients with cannabis use disorder.

The format and mode of the intervention will be informed by the cultural adaptation process above. The intervention will consist of a structured CA-CBT program designed to help individuals with CUD in Khyber Pakhtunkhwa, Pakistan. Based on the literature, we predict that it will include six to eight therapy sessions, each targeting specific aspects of cannabis dependence and its management. The program will begin by helping participants understand their cannabis use patterns and set personalized goals through motivational enhancement training. Subsequent sessions will teach practical strategies for coping with cravings, managing withdrawal symptoms, and addressing negative thought patterns that may hinder progress. Participants will also learn how to plan for quitting, identify triggers, and navigate high-risk situations while building a supportive network of people who can aid in their recovery. In the final sessions, participants will learn relapse prevention techniques and be encouraged to adopt a healthier lifestyle. Each session will be interactive, using culturally relevant examples, and will be delivered through a combination of psychoeducation, skill-building exercises, and practical homework assignments to reinforce learning and support behaviour change.

The study will primarily focus on assessing the intervention’s feasibility, appropriateness, and acceptability. The secondary outcomes include cannabis use frequency and amount of cannabis use. Table 1 outlines the metrics and tools used to evaluate CA-CBT for cannabis use. It includes measures for CUD, cannabis use frequency, and the amount consumed, alongside the feasibility and acceptability of the intervention (Supplementary document 1).

The data collection procedure will commence with the therapists’ recruitment of participants from hospitals, where informed consent will be obtained from those meeting the inclusion criteria. Initial assessments will be conducted by the researcher, using the CUDIT, to identify symptoms of cannabis use disorder, and self-reported data on cannabis use frequency and amount of use will be collected using questionnaires. During the intervention phase, when participants engage with the CA-CBT, the researcher will closely monitor adherence and session attendance. At the end of the intervention, the researcher will carry out the follow-up assessments, including re-administration of the CUDIT and the collection of updated self-reported data on cannabis use. Feasibility metrics, such as follow-up completion rates and adherence, will be evaluated. Additionally, acceptability will be assessed using the Acceptability of Intervention Measure (AIM) and open-ended feedback from participants and therapists. The open-ended feedback will be obtained using the following questions. 1.

“Can you describe your overall experience with the CA-CBT sessions and what aspects of the therapy you found most helpful or challenging?”

The data analysis will use descriptive and inferential statistical methods to evaluate the CA-CBT intervention. Given the small sample size (12 participants), non-parametric tests such as the Wilcoxon signed-rank test will be used to compare pre- and post-intervention CUDIT scores, and cannabis use frequency and quantity. Feasibility will be assessed using descriptive statistics (means, medians, and percentages) to summarize recruitment, engagement, retention, and adherence rates. Acceptability will be evaluated using Acceptability of Intervention Measure (AIM) scores, analyzed through descriptive statistics and Wilcoxon tests, along with thematic analysis of qualitative feedback to explore satisfaction, relevance, and ease of use. NVivo (version 14) software will be used for qualitative data analysis, applying thematic framework analysis to identify key patterns. Quantitative analysis will be conducted using Stata (Version 18.0) to ensure accurate interpretation of results.

Withdrawal from the study

This study is not expected to pose significant risks to participants. However, discussing personal experiences may cause discomfort for some individuals. To address this, participants will be informed that they can choose not to answer any questions that make them uncomfortable. All information will be handled with strict confidentiality to protect their privacy. Participants will have the right to withdraw from the study at any time without providing a reason, and they can request that their data not be used within a specified period.

Adverse events

The CA-CBT intervention has no direct impact on the physical health of the patients. However, it has known effects on the cognition and behaviours of the patients. During treatment, patients can face the withdrawal effects of cannabis. These effects will be assessed by the therapists and will be considered as non-adverse, adverse, or serious adverse events based on the nature and severity of the events. The events will be reported and treated by the therapists according to the hospital protocols.

This study will demonstrate methodological rigor through a structured adaptation process integrating qualitative research with a participatory approach using an established SAF for adaptation of CBT. The use of FGDs, IDIs, and co-adaptation workshops ensures that diverse perspectives, including those of patients, caregivers, mental health professionals, and community leaders, are incorporated into the intervention, through the key areas identified in SAF. This engagement will enhance the cultural relevance and acceptability of CBT, fostering greater treatment adherence. Patient and public involvement further strengthens the study by promoting transparency, trust, and alignment with community needs. The iterative adaptation process, guided by expert reviews, ensures that core therapeutic principles are preserved while modifications address cultural sensitivities. This systematic approach enhances reliability and reproducibility, making CA-CBT suitable for real-world implementation. The study provides a replicable framework for adapting psychological interventions in resource-limited settings, offering a sustainable model for improving mental health treatment accessibility and effectiveness in diverse populations.

Despite these strengths, several limitations require careful consideration that may impact the study’s findings and broader applicability. The qualitative component, comprising two FGDs and 15 in-depth interviews with 27–31 participants, is designed to explore experiences rather than achieve generalizability. The study is limited to tertiary care hospitals in Peshawar, which may introduce selection bias and affect the applicability of findings to other settings. Cultural sensitivities around cannabis use, particularly its association with males, may result in limited female participation, reducing the diversity of perspectives. Recruitment may also be challenging due to the stigma attached to cannabis use. Additionally, the reliance on self-reported measures for cannabis use frequency and quantity may introduce bias or inaccuracies. While the study aims to assess the feasibility and acceptability of CA-CBT, the small sample size and specific cultural context may limit the extent to which the findings can be applied more broadly. The effectiveness of CA-CBT in reducing cannabis use may not show significant clinical or statistical improvements, but the results will provide valuable insights for refining the intervention and informing future research.

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The study will assess the feasibility, acceptability, and appropriateness of a culturally adapted cognitive behavioral therapy for cannabis use disorder in a low-resource setting.