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NCT Number: NCT07672457

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Self-reported diagnosis of a substance use disorder
  • Inability to provide informed consent

Treatment and study plan

Acceptance and Commitment Therapy

Behavioral

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.

Attention Control

Behavioral

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

Primary outcomes

  1. Feasibility of the ACT Intervention

    Time frame: 1 month and 6 months

    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.

  2. Acceptability of the ACT Intervention

    Time frame: 1 month and 6 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Karsten Lunze, MD DrPH MPH

CONTACT

[email protected]

617-414-6933

Kimberly Hook, PhD MA

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Boston Medical Center

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Acronym: SUPRA RCT R33

Important dates

Study start
2027
Primary completion
2028
Study completion
2028
First posted
Jun 29, 2026
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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