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

Boston Medical Center (BMC)

Status: Begins enrollment in 6 months

Conditions: Prevention; Refugee Health; Substance Use

Treatments: Behavioral: Attention Control; Behavioral: Acceptance and Commitment Therapy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07672457

R33DA059856 (U.S. NIH Grant/Contract)

H-46965

Details and patient eligibility

About

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.

Full 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.

Enrollment: 144 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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144 participants in 2 patient groups

ACT Therapy

Experimental group

Description:

Participants randomized to this group will receive the ACT intervention

Treatment:

Behavioral: Acceptance and Commitment Therapy

Attention Control

Active Comparator group

Description:

Participants in the control group will receive minimally enhanced usual care to receive treatment as usual enhanced by a health information group session.

Treatment:

Behavioral: Attention Control