Comparative evaluation of transtheoretical model, multi theory model and hybrid theory model on the efficacy in smoking cessation among smokers: protocol for a cluster randomized interventional study.

Introduction

Consumption of tobacco all over the world is considered to create morbidity and mortality that could be potentially preventable.¹ Tobacco is said to be the major cause for non-communicable disease all over the world. Mortality because of NCDs responsible for about 63%.² 80 percent of the deaths related to tobacco occur in the Low and Middle Income Countries throughout the world.³ According to WHO, mortality due to the diseases that are connected to tobacco has increased from 1.4% in 1990 to 13.3% in 2020.⁴ Deaths associated to tobacco in India by 2020 is evaluated to be 1.5 million.⁵ The two main forms of consuming tobacco are smoking and smokeless tobacco.

In our country, tobacco consumption has become challenging and a complex issue, with a wide range of smoking forms as well as smokeless tobacco product. Tobacco usage is prevalent and practised in India in a variety of ways. Tobacco use is increasing at a rate of 2% to 3% each year, and it is estimated that smoking is responsible for 13% of all demises in the country. Our country is currently representing a steadfast commitment for combating the tobacco problem by developing a wide-ranging control scheme that includes a variety of demand and supply reduction techniques. The anti-tobacco legislation in our country, which was initially adopted at the national level in 1975, was mostly restricted to health warnings and proved ineffective.⁵ The ‘Cigarettes and Other Tobacco Products Bill, 2003’ was a significant step forward in tobacco control legislation. Innovative means of mobilising human and financial resources for tobacco control, the establishment of effective national coordinating mechanisms, the integration of tobacco control into health and development programmes, and the periodic evaluation of these activities are all critical.^6,7

Cigarette smoking degrades a smoker’s health since it damages several organs in the body and can lead to a variety of ailments. Smoking is accountable for about 85% of lung cancer cases. Smoking can lead to around 85% of lung cancers and majority of cancer deaths are due to tobacco consumption. Cardiovascular events may take place as a consequence of smoking and altering this behaviour would lead to better health outcomes. Cessation of smoking serves to be beneficial for health and these benefits include lessening of morbidity and mortality caused due to smoking, progression of current illness gets slow, improved functioning etc.⁸

In spite of the promise of public health interventions to help smokers quit, their effectiveness and application in different settings are limited. Using a computer-tailored smoking prevention intervention web-based, for instance, has proven to significantly promote quitting smoking. Although the current program is good for promoting smoking cessation initiation, it hasn’t been shown to sustain quitting of smoking beyond six months, and its complex design can make it difficult for it to be widely implemented. Additionally, most interventions focus primarily on assisting with beginning of smoking cessation behaviors, while paying less focus on maintaining those behaviors. An experience smoking intervention based on dissonance appears to be successful in strengthening the desire to quit. Nevertheless, it doesn’t seem to be successful in helping people quit the desire to smoke for the long term.⁹ Bailey et al. found that no medication therapy they looked at could be utilised to significantly promote smoking cessation over time. When it comes to long period maintenance of quitting smoking, very few modalities have been found to be effective. Smoking is based on both operant and classical conditioning processes. If conditioning is stopped in time, smoking cessation is possible. Behavioral changes are therefore required in order to stop smoking.¹⁰

Counselling can involve a variety of methods. With the help of a fourth-generation framework, the multi-theory model predicts changes in health behaviour over time.^11,12 Because of the lack of moderators, the model’s fluidity allows the constructs to be modified to a wide range of behaviours. MTM is unique among health behaviour models in that it allows practitioners to decide the most successful strategy for encouraging patients to start and maintain healthy habits without needing to consult several models. In the MTM the health behaviour change is separated into initiation and maintenance or continuity of the health behaviour change.^13–16

The Transtheoretical Model can help you understand how individuals and populations develop toward adopting and maintaining healthy habits (TTM). The transtheoretical model combines elements of psychotherapy and behaviour modification philosophies. During the five stages of the model (precontemplation, contemplation, preparation, action, and maintenance), behaviour changes can be observed. To be most productive, intervention of a health care contributor should coincide with the patient’s stage of change. Ten cognitive and behavioural processes are involved in the model that shows how change takes place when a person is moving among the stages. Change is described in terms of the coping mechanisms utilised by the processes (social liberation, dramatic relief, assisting connections, conscious experience, environmental re-evaluation, reinforcement management, self-re-evaluation, sensory stimulation, counterconditioning, and independence). When intervening, the pharmacist must first ask questions regarding the patient’s behaviour in order to determine the stage of the disease. Those in the contemplation stage are inclined to learn more about smoking and its impacts on their wellbeing, but those in the planning phase are ready to set objectives and make decisions regarding quitting methods. Smokers who are in the executing phase are trying to quit smoking.^17,18

Modified MTM is a health behaviour theory that predicts one-time and long-term health behaviour modification using a fourth-generation framework. The model’s flow allows the components to be changed to varied changes in health behaviour. This model represents the modified version of multi theory model due to the various lacunae being assessed by the researchers such as the self-reporting analysis as the crucial method for collection of data. False reporting, dishonesty, poor evaluation, subjectivity, and other factors can all lead to bias in self-reports. Researchers who use this method must additionally use more objective techniques to supplement their measurements. Hence this modified method will record their self-reflection diary and co-relate with their third person (i.e., relative) record diary facilitating the social support to assess the false reporting of the participant. This will also provide the instrument of measurement of cotinine levels pre intervention, during the intervention and post intervention. The modified version will provide motivational interviewing along with participatory dialogue for enhancing the willingness to quit. Using this unified framework method, find the most effective technique to motivate their patients to start and maintain healthy habits. The protocol will aid in conduct of research to assess and compare the efficacy of Multi theory Model and Modified Multi theory model as against Transtheoretical model as assessed by Nicotine Dependence, Stages of Change Scale, Smoking abstinence and urine cotinine level on smoking cessation at Community Level.

Methods

Protocol amendments

If the trial protocol is to be changed after approval, the same people who signed the trial protocol must sign a written amendment. Any changes to the protocol will indeed take effect once they’ve been accepted by the IEC as well as the appropriate authorities. Any significant protocol modification impacting the benefit-to-risk ratio will be disclosed to the appropriate IEC. Any significant modifications to the experiment will be communicated to participants, and they will be required to reaffirm their consent in writing (Figure 1).

Figure 1. Implementation: Random allocation Sequence (10).

Discussion

Transtheoretical Model is the standard health model used for Smoking cessation behavioural methods. The transtheoretical model in which the applied research was conducted was assessed by Jo P and Velicer WF. Improvements in recruiting, persistence, and development have been demonstrated utilizing phase therapies and active selection procedure. Consistent patterns have been observed across 12 different health behaviours, among the benefits and costs of change, as well as the many changes process. Across 12 health habits, consistent connections between the benefits and drawbacks of altering and the stages of change were established. Computer-based personalised and interactive interventions have yielded the most promising data outcomes.²⁵ A study conducted by Bakan AB and Erci B examined the transtheoretical and health belief models with 96 volunteer nurses. Using a validated questionnaire method, the impact of both models on smoking cessation was assessed. The health belief model group’s negative opinions toward smoking were much greater than the Trans theoretical Model groups. The transtheoretical model approach has shown more positive effect in behavior change.²⁶

A 38-item, face and content validated, MTM-based survey questionnaire was provided to the participants in a study conducted by Nahar VK et al. Participatory discussion and behavioural confidence were both important indicators of smoking cessation behaviour intention. Emotional transformation was a significant predictor of intention for sustenance for smoking cessation behaviour.²⁷

MTM predicts health behaviour change across cultures by claiming that health behaviour change happens in two stages: initiation and maintenance. Several other health behaviour improvements have been validated using this paradigm. The best probable determinants of smoking cessation start and persistence within cigarette smokers were discovered using multiple regressions. The purpose of this research is to see how well MTM can describe tobacco cessation and protracted maintenance in smokers.²⁸

Carolyn J Heckma et al., determined the efficiency of motivational interviewing for smoking cessation by a comprehensive review and meta-analysis The data imply that current MI smoking cessation methods could help adolescents and adults quit smoking. The superiority of MI over control therapies did not decrease over time in studies with more than one follow-up time point. The effects of MI differed between trials, and it was difficult to pinpoint intervention or research factors that contributed to impact size heterogeneity. This superiority of Motivational Interviewing has been factor should be compared with other approaches for its better effectiveness. The combination of Motivational Interviewing with MTM can significantly improve the chances of smoking cessation among the smokers i.e., modified multi theory model.²⁹

Nicola Lindon Hawley (2015) A systematic evaluation found 28 studies published between 1997 and 2014 with over 16,000 participants. MI was done in a series of one-six sessions, each lasting about 10 and 60 minutes. Motivational questioning seems to be fairly fruitful in helping people quit smoking in comparison to standard care or brief recommendations. Studies that assessed more intense versus less intensive motivational interviewing as part of their study design indicated that less intensive support was linked to higher abstinence rates.³⁰ Gholamreza Heydari, et al. 2014, performed a literature search which was done from 2000 to 2012 to gather information on the pharmacological and behavioral interventions on smoking cessations. The inter-rater reliability was 67% before discussion for a better analysis. All the article for behavioral interventions has proven a better quit rate with positive effect. Less studies were conducted on such methods and more approaches in combination are encouraged. All the studies promote the evaluation of various behavioral techniques for identifying the current evidence and latest outcomes.³⁰

Conclusion

National Tobacco control program implemented in India have been merged with various other governing bodies for reducing the consumption and supply of tobacco. The efforts have been undermined due to lack of utilization of tobacco cessation cell services placed at an institutional setting and costly pharmacotherapy management. Implementation of Behavioral Change Methods i.e., the Multi theory Model and Modified Multi theory Model can help the community in improving their health status by advancing smoking cessation approaches at primary health centers and a resource scarce setting. On overcoming the limitations of transtheoretical model by conducting theory-comparison and multiple-behavior research can prove to be a better approach for smoking cessation to the community. New methods of behaviour modification, such as the Modified Multi Theory Model, will be used to improve recruitment and retention, particularly among diverse populations; improve treatment fidelity; develop common metrics across behaviours that can be used to advance the measurement and assessment of smoking cessation; and expand the reach of effective intervention approaches through translation.

Implication: This study helps towards long term smoking cessation among the smokers by the application of Transtheoretical model, Multi theory Model and Modified Multi theory Model.

Study status: selection of participants for each group.