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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBoston Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Self-reported diagnosis of a substance use disorder

Inability to provide informed consent

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

144 Participants
are divided into 2 treatment groups
Group A: ACT TherapyExperimental treatment 1 intervention
Group B: Attention ControlActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
1 month and 6 months
2

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.

Time frame
1 month and 6 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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Boston Medical Center

Lead sponsor

National Institute on Drug Abuse (NIDA)

Collaborator

This trial is not recruiting at the moment. You can still explore other options: