Substance Use Prevention for Recently Displaced Adults - SUPRA (R33) RCT (SUPRA RCT R33)

This study is a randomized controlled trial among 144 internally displaced people to determine the feasibility, acceptability, and preliminary effectiveness of a single-session Acceptance of Commitment Therapy (ACT) group therapy on preventing or reducing substance use behaviors.

Study Overview

• Status: Not yet recruiting
• Conditions: Substance Use; Prevention; Refugee Health
• Intervention / Treatment: Behavioral: Acceptance and Commitment Therapy; Behavioral: Attention Control

Detailed Description

The war in Ukraine has provoked the world's current largest humanitarian displacement: since February 2022, over 13 million people, i.e., one-third of Ukrainians, have been forced to leave their homes, resulting in nearly 6 million internally displaced persons (IDPs). War and humanitarian emergencies may exacerbate substance use, but the incidence and prevalence of unhealthy substance use in humanitarian settings, including Ukraine, are currently largely unknown. This lack of data limits the ability to tailor targeted, effective preventive substance use interventions for these mobile populations. Addressing this knowledge gap is an immense priority for Ukraine, where rates of substance use were high even prior to the Russian invasion in February 2022, and in other settings hosting large populations of IDPs, including the United States.

To determine the feasibility, acceptability, and preliminary effectiveness of the intervention among IDPs, a RCT to evaluate implementation and substance use outcomes associated with the intervention at 1 and 6 months.

The investigators hypothesize that an ACT-based intervention delivered in a humanitarian context will help displaced persons in Ukraine build skills to manage stress and prevent or reduce substance use behaviors, ultimately mitigating the onset of substance use disorders.

• Study Type: Interventional
• Enrollment (Estimated): 144
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Karsten Lunze, MD DrPH MPH; Phone Number: 617-414-6933; Email: lunze@bu.edu
• Study Contact Backup: Name: Kimberly Hook, PhD MA; Email: kmhook@hsph.harvard.edu

Study Locations

• Ukraine
  • Kyiv, Ukraine
    • Alliance for Public Health
    • Contact: Pavlo Smyrnov; Phone Number: +380 44 490-5485; Email: Smyrnov@aph.org.ua

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age 18 or over
2. Have been displaced at least once due to Anti-Terrorist Operation (ATO) or full-scale invasion since 2014
3. Self-reported use of at least one substance other than alcohol and tobacco within the past 3 months
4. Ability to provide informed consent and speak Ukrainian or Russian

Exclusion Criteria:

1. Self-reported diagnosis of a substance use disorder
2. Inability to provide informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ACT Therapy; Participants randomized to this group will receive the ACT intervention	Behavioral: Acceptance and Commitment Therapy; The ACT group intervention will involve a mixture of didactic instruction, discussion, and experiential activities. ACT will help internally displaced persons to manage stress and prevent or reduce substance use behaviors, ultimately mitigating the onset of substance use disorders.
Active Comparator: Attention Control; Participants in the control group will receive minimally enhanced usual care to receive treatment as usual enhanced by a health information group session.	Behavioral: Attention Control; Usual care will be minimally enhanced by providing participants with an educational information session that provides information on health promotion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of the ACT Intervention	Feasibility will be assessed using the 14-item feasibility subscales of the Applied Mental Health Research Group Implementation Measure (AMHR-IM). Each item is rated on a 4-point scale where "0" means "not at all" and "3" means "a lot". The overall Feasibility score is calculated as the mean (average) across all 14 completed items, where higher scores (closer to 3) reflect a higher level of perceived feasibility of the intervention.	1 month and 6 months
Acceptability of the ACT Intervention	Acceptability will be assessed using the 17-item acceptability subscales of the Applied Mental Health Research Group Implementation Measure (AMHR-IM). Each item is rated on a 4-point Likert scale where "0" means "not at all" and "3" means "a lot". The overall Acceptability score is calculated as the mean (average) across all 17 completed items, where higher scores (closer to 3) reflect a higher level of perceived acceptability of the intervention.	1 month and 6 months

Collaborators and Investigators

• Sponsor: Boston Medical Center
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Karsten Lunze, MD DrPH MPH, Boston University Chobanian & Avedisian School of Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2027
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: June 23, 2026
• First Submitted That Met QC Criteria: June 23, 2026
• First Posted (Actual): June 29, 2026

Study Record Updates

• Last Update Posted (Actual): June 29, 2026
• Last Update Submitted That Met QC Criteria: June 23, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Substance Use; Ukraine; Displacement
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Cognitive Behavioral Therapy; Acceptance and Commitment Therapy
• Other Study ID Numbers: H-46965; R33DA059856 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No