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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07672457
Acronym
SUPRA RCT R33
Enrollment
144
Registered
2026-06-29
Start date
2027-04-01
Completion date
2028-12-01
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prevention, Refugee Health, Substance Use

Keywords

Displacement, Ukraine, Substance Use

Brief summary

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.

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.

Interventions

BEHAVIORALAcceptance 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.

BEHAVIORALAttention Control

Usual care will be minimally enhanced by providing participants with an educational information session that provides information on health promotion.

Sponsors

Boston Medical Center
Lead SponsorOTHER
National Institute on Drug Abuse (NIDA)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Feasibility of the ACT Intervention1 month and 6 monthsFeasibility 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.
Acceptability of the ACT Intervention1 month and 6 monthsAcceptability 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.

Countries

Ukraine

Contacts

CONTACTKarsten Lunze, MD DrPH MPH
lunze@bu.edu617-414-6933
CONTACTKimberly Hook, PhD MA
kmhook@hsph.harvard.edu
PRINCIPAL_INVESTIGATORKarsten Lunze, MD DrPH MPH

Boston University Chobanian & Avedisian School of Medicine

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 30, 2026