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ProtocolInternational Journal of Clinical Trials

Publication:
Comparing a multicomponent intervention versus a single component intervention for people with co-occurring substance use and mental health disorders: study protocol of a hybrid type I trial

Int J Clin Trials. 2025;12(4):287-296.DOI10.18203/2349-3259.ijct20253334

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Abstract

Background Substance use and mental health are growing public health problems in the United States. People with co-occurring mental health and substance use disorders (COD) often have complex social determinants of health (SDOH) needs and struggle to engage in treatment. Linkage and multicomponent wraparound interventions, including maintaining independence and sobriety through systems integration, outreach and networking (MISSION), have gained popularity as solutions to increase treatment engagement and address behavioral health and SDOH needs of clients with COD. This protocol offers an overview of an effectiveness trial and a process evaluation of MISSION being delivered in a city public health setting.

Methods This study will use a hybrid type I effectiveness and implementation design with a randomized controlled trial. People with COD will be randomized to one of two treatments: a multicomponent COD intervention (MISSION), or a peer delivered linkage-only intervention (PLS). Secondary aims include the examination of mechanisms of action and a sequential mixed methods process evaluation to inform the sustainability and future implementation of MISSION.

Conclusions This trial will help determine the effectiveness of MISSION compared to PLS to improve engagement, and reduce substance use and mental health symptoms. This trial is the first to implement MISSION within a public health department setting which has important implications for policymakers and treatment providers within behavioral health fields. Trial Registration: Trial registration number is NCT05713695, registered on 27 January 2023.

Keywords

Affiliations

  1. Department of Medicine, University of Massachusetts Chan Medical School, Worcester, MA, USA
  2. Department of Public Health, Center for Health Statistics and Biostatistics Core, University of Massachusetts, Lowell, MA, USA
  3. Department of Health Promotion and Policy, School of Public Health and Health Sciences, University of Massachusetts Amherst, MA, USA
  4. Institute for Global Health, University of Massachusetts Amherst, MA, USA

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