NCT07672457

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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
144

participants targeted

Target at P75+ for not_applicable

Timeline
20mo left

Started Apr 2027

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 23, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 29, 2026

Completed
9 months until next milestone

Study Start

First participant enrolled

April 1, 2027

Expected
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

June 29, 2026

Status Verified

June 1, 2026

Enrollment Period

1.7 years

First QC Date

June 23, 2026

Last Update Submit

June 23, 2026

Conditions

PreventionSubstance UseRefugee Health

Keywords

DisplacementUkraineSubstance Use

Outcome Measures

Primary Outcomes (2)

  • 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.

    1 month and 6 months

  • 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.

    1 month and 6 months

Study Arms (2)

ACT Therapy

EXPERIMENTAL

Participants randomized to this group will receive the ACT intervention

Behavioral: Acceptance and Commitment Therapy

Attention Control

ACTIVE COMPARATOR

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

Behavioral: Attention Control

Interventions

Acceptance and Commitment TherapyBEHAVIORAL

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.

ACT Therapy
Attention ControlBEHAVIORAL

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

Attention Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alliance for Public Health

Kyiv, Ukraine

Location

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Acceptance and Commitment Therapy

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Karsten Lunze, MD DrPH MPH

    Boston University Chobanian & Avedisian School of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Karsten Lunze, MD DrPH MPH

CONTACT

617-414-6933lunze@bu.edu

Kimberly Hook, PhD MA

CONTACT

kmhook@hsph.harvard.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2026

First Posted

June 29, 2026

Study Start (Estimated)

April 1, 2027

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

June 29, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

UA(1)