CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 400 enrolled
Drug / intervention
SBIRT +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05471921
NCT05471921N/ACompleted

Effectiveness of an Evidence-based Stepped Care System for Alcohol and Other Drug Use Problems Among Congolese Refugees in Zambia: A Randomized Controlled Trial

Columbia University·interventional·Posted Jul 25, 2022·Updated Nov 6, 2025

In Brief

A clinical study evaluating SBIRT and Treatment as usual for Alcohol and Substance-Related Mental Disorders. Completed, enrolled 400 participants across 2 sites in 2 countries.

Detailed Summary

This is a randomized controlled trial (RCT) evaluating the effectiveness of a screening, brief intervention, and referral to treatment (SBIRT) stepped-care system in reducing unhealthy AOD use among Congolese refugees and the host community in Mantapala, an integrated settlement in northern Zambia.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States, Zambia
CollaboratorsElrha

Timeline

N/ACompletedFinished
2023202420252026
First PostedJul 25, 2022
Enrollment StartApr 26, 2023
Primary CompletionFeb 24, 2025
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 3.9 years ago

Interventions

SBIRTbehavioral

SBIRT is an evidence-based treatment for unhealthy alcohol and other drugs (AOD) use in non-humanitarian settings and can efficiently provide individuals with an appropriate level of care based on their symptoms. Participants randomized to SBIRT will receive an on-the-spot alcohol brief intervention (CETA-BI) and be categorized as low or moderate/high severity using the AUDIT scale. Participants who are moderate/high severity will be connected to a counselor and will begin full CETA treatment. CETA is a transdiagnostic approach that combines motivational interviewing with cognitive behavioral therapy to assist clients in considering changing their rates of AOD use. The intervention lasts 30-40 minutes and consists of 6 components including 1) screening; 2) identifying the impacts of unhealthy AOD use; 3) talking about change/goal-setting; 4) understanding the primary reason for drinking; 5) skill-building; and 6) referral for services.

Treatment as usualbehavioral

Mantapala health workers and supervisors were trained in mental health gap action program-humanitarian intervention guide (mhGAP-HIG), which is a mental health service provision guide for use in humanitarian settings; this training was led by staff from United Nations High Commissioner for Refugees. This training did not include evidence-based psychological interventions (e.g., CETA). Participants randomized to TAU will be referred to the existing services that exist in the health clinic located in Mantapala refugee settlement. More specialized services are referred to the District Hospital in Nchelenge.