Substance Use Prevention for Recently Displaced Adults - SUPRA (R33) RCT
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Acceptance and Commitment Therapy, Attention Control.
- Who it may be relevant to
- Registry conditions: Prevention, Substance Use, Refugee Health. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Ukraine
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- 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. - Behavioral Attention Control
Usual care will be minimally enhanced by providing participants with an educational information session that provides information on health promotion.
Primary outcome measures
- Feasibility of the ACT Intervention [Time frame: 1 month and 6 months]
- Acceptability of the ACT Intervention [Time frame: 1 month and 6 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Ukraine · 1 center
- Alliance for Public Health — Kyiv
Identifiers
NCT: NCT07672457 · H-46965 · R33DA059856