TY - JOUR
T1 - Relapse prevention group therapy via video-conferencing for substance use disorder
T2 - Protocol for a multicentre randomised controlled trial in Indonesia
AU - Yamada, Chika
AU - Siste, Kristiana
AU - Hanafi, Enjeline
AU - Ophinni, Youdiil
AU - Beatrice, Evania
AU - Rafelia, Vania
AU - Alison, Peter
AU - Limawan, Albert
AU - Shinozaki, Tomohiro
AU - Matsumoto, Toshihiko
AU - Sakamoto, Ryota
N1 - Funding Information:
Contributors CY, KS and YO conceptualised the study. CY, KS, EH and YO are the main developers of the Indo-DARPP module, designed study methodology, invited and coordinated site investigators, conducted training of providers, wrote the protocol and reviewed and edited the final manuscript. EB, VR, PA and AP helped in module development, study design, training of providers and site coordination. TS provided biostatistical and epidemiological supervision. TM provided the original SMARPP module and clinical input and perspectives to improve study quality. RS supervised the whole study and procured grants. CY and RS are the principal investigators of the grants. All authors have read and approved the final manuscript. Funding This work was supported by the Japan-ASEAN Platform for Transdisciplinary Studies project of the Center for Southeast Asian Studies of Kyoto University, Research Unit for Development of Global Sustainability of Kyoto University and the Japan Society for the Promotion of Science (JSPS) Grants-in-Aid for Scientific Research (KAKENHI) (Grant number JP19K24256).
Publisher Copyright:
© 2021 BMJ Publishing Group. All rights reserved.
PY - 2021/9/6
Y1 - 2021/9/6
N2 - 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.
AB - 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.
KW - clinical trials
KW - psychiatry
KW - substance misuse
KW - telemedicine
UR - http://www.scopus.com/inward/record.url?scp=85114681155&partnerID=8YFLogxK
U2 - 10.1136/bmjopen-2021-050259
DO - 10.1136/bmjopen-2021-050259
M3 - Article
C2 - 34489288
AN - SCOPUS:85114681155
SN - 2044-6055
VL - 11
JO - BMJ open
JF - BMJ open
IS - 9
M1 - e050259
ER -