Relapse prevention group therapy via video-conferencing for substance use disorder: protocol for a multicentre randomised controlled trial in Indonesia

Abstract

Background: Substance use disorder (SUD) is a leading contributor to the global burden of disease. In Indonesia, the availability of formal treatment for SUD falls short of the targeted coverage. A standardised therapeutic option for SUD with potential for widespread implementation is required, yet evidence-based data in the country are scarce. In this study, we developed a cognitive behavioural therapy (CBT)-based group telemedicine model and will investigate effectiveness and implementability in a multicentre randomised controlled trial.

Methods: A total of 220 participants will be recruited from the social networks of eight sites in Indonesia: three hospitals, two primary healthcare centres and three rehabilitation centres. The intervention arm will participate in a relapse prevention programme called the Indonesia Drug Addiction Relapse Prevention Programme (Indo-DARPP), a newly developed 12-week module based on CBT and motivational interviewing constructed in the Indonesian context. The programme will be delivered by a healthcare provider and a peer counsellor in a group therapy setting via video-conferencing, as a supplement to participants' usual treatments. The control arm will continue treatment as usual. The primary outcome will be the percentage increase in days of abstinence from the primarily used substance in the past 28 days. Secondary outcomes will include addiction severity, quality of life, motivation to change, psychiatric symptoms, cognitive function, coping, and internalised stigma. Assessments will be performed at baseline (week 0), post-treatment (week 13), and 3 and 12 months post-treatment completion (weeks 24 and 60). Retention, participant satisfaction, and cost-effectiveness will be assessed as the implementation outcomes.

Ethics and dissemination: The study protocol was reviewed and approved by the Ethics Committees of Universitas Indonesia and Kyoto University. The results will be disseminated via academic journals and international conferences. Depending on trial outcomes, the treatment programme will be advocated for adoption as a formal healthcare-based approach for SUD.

Trial registration number: UMIN000042186.

Keywords: clinical trials; psychiatry; substance misuse; telemedicine.

Figure 1

Study flowchart for each site. A total of 20 or 30 participants will be recruited through the social network of each site. After 10 participants have been recruited to constitute one wave, they will be randomly allocated into two arms: intervention (Indo-DARPP+TAU) and control (TAU only), with five participants in each arm. Recruitment will be continued until another 10 or 20 participants (second or third wave) join, in a similar procedure. Treatment period will be 12 weeks. Assessments will be conducted four times: T1 (week 0) during baseline or before randomisation, T2 (weeks 13–16) during postassessment or 1–4 weeks after treatment period ends, T3 (week 24) at 3 months after treatment ends and T4 (week 60) at 12 months after treatment ends. DARPP, Drug Addiction Relapse Prevention Programme; TAU, treatment as usual.

Figure 2

Planned trial schedule across all eight research sites. Staggered schedules were designed to spread the assessment workload of providers and research staff. After training the providers, all sites will be given approximately 1–2 months to recruit participants. Sites with relatively higher potential to recruit faster, that is, those with higher rates of patient turnover, have been selected first in the schedule. Each site will have two or three waves of recruitment and treatment periods.