Culturally Adapted Motivational Interviewing with Cognitive Behavior Therapy and Mindfulness Based Relapse Prevention for Substance Use Disorder in Pakistan (CAMAIB): Protocol of a feasibility factorial randomised controlled trial

Abstract

Background The use of psychoactive substances significantly impacts the health, social and economic aspects of families, communities and nations. There is a need to develop and test psychological interventions aimed for people with Substance Use Disorder (SUD) in Lower and Middle Income Countries (LMICS), such as in Pakistan. The aim of this exploratory trial is to test the feasibility and acceptability of two culturally adapted psychological interventions in a factorial Randomized Controlled Trial (RCT). Methods The proposed project will be conducted in three phases. The first phase of the study will focus on cultural adaptation of the interventions through qualitative interviews with key stakeholders. The second phase will be to refine the intervention and to produce manual assisted intervention. Third and last stage would be to assess the feasibility of the culturally adapted interventions through a factorial RCT. The study will be carried out in Karachi, Hyderabad, Peshawar, Lahore and Rawalpindi, Pakistan. Recruitment of participants will take place from primary care and volunteer organisations/drug rehabilitation centres. A total of 260 individuals diagnosed with SUD (n=65) in each of the four arms will be recruited. The intervention will be delivered weekly over a period of 12 weeks in both individual and group setting. Assessments will be carried out at baseline, at 12th week (after completion of intervention) and 24th week post-randomisation. The analysis will determine feasibility of recruitment, randomisation, retention and intervention delivery. Acceptability of intervention will be determined in terms of adherence to intervention i.e. the mean number of sessions attended, number of home assignments completed, attrition rates as well as through process evaluation to understand the implementation process, context, participants’ satisfaction, and impact of study intervention. The health resource use and impact on the quality of life will be established through health economic data. Discussion This study will provide evidence for feasibility and acceptability of culturally adapted manually assisted psychological interventions for people with SUD in the context of Pakistan. The study will have clinical implications if intervention is proven feasible and acceptable. Trial registration Name of the registry: ClinicalTrials.gov Trial registration number: NCT04885569 Date of registration: 25th April 2021, retrospectively registered URL of trial registry record: https://clinicaltrials.gov/ct2/show/NCT04885569