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Alcohol and Substance-Related Mental DisordersNCT05471921

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

A study testing SBIRT and Treatment as usual in people with Alcohol and Substance-Related Mental Disorders, run by Columbia University at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 15 years and older
What is being tested?
SBIRT and Treatment as usual
Could I receive a placebo?
No, everyone receives an active treatment
How many people
400 participants
Where
2 sitesin 2 countries
Study dates
26 Apr 2023to 24 Feb 2025
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Living in Mantapala refugee settlement (i.e., Congolese refugee) or (Zambian) member of neighboring host community
  • Unhealthy alcohol use based on standard cut-off scores of the ACASI-based Alcohol Use Disorders Identification Test (AUDIT)20 (≥ 8 for men and ≥ 4 for women).21 The focus on unhealthy alcohol use as the primary inclusion criterion is due to preliminary research in Mantapala suggesting that alcohol is the main substance of concern and other drug use almost exclusively co-occurs with alcohol use.

Who cannot join

  • Severe psychiatric illness, high suicide risk (based on recent attempts and/or ideation with intent and plan), and/or current severe AOD withdrawal that would necessitate immediate referral for psychiatric services
  • Inability or unwillingness to provide informed consent

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

United States1 site
  • Columbia University

    New York, New York, 10032

Other trials in United States

Zambia1 site
  • Mantapala Refugee Settlement

    Nchelenge, Luapula Province

Other trials in Zambia

About this study

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

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.

Read the detailed description

Refugees are at risk for unhealthy alcohol and other drug (AOD) use, particularly in protracted emergencies. The investigators define unhealthy AOD use as hazardous use, harmful use, and alcohol/substance use disorder and dependence. Among refugees, baseline risk for AOD use may increase for several reasons, including access to illicit substances (reduced drug enforcement policies and security), exposure to potentially traumatic events, and chronic adversity. Ongoing adverse environments such as refugee camps, are associated with lack of access to basic needs, limited livelihoods opportunities, boredom, marginalization, loss of resources, and mental health problems leading to the use of AOD as a coping mechanism. Studies have suggested that in conflict settings, quantity and frequency of use tend to increase from the pre-conflict stage to peri- and post-conflict. Increase in use of one substance can also lead to initiation of new substances, resulting in more complex cases of polysubstance use.

In Mantapala refugee settlement in Zambia, the proposed study setting, unhealthy AOD use is reportedly common. In July 2019, United Nations High Commissioner for Refugees (UNHCR) requested psychiatric clinical officers from local health facilities in Nchelenge, Zambia to do an assessment of mental health problems among refugees in Mantapala. The community-based convenience sample consisted of 200 people, of whom 35 (18%) had probable alcohol use disorder, mostly adult men and adolescents (male and female), and frequent cannabis use among people who were drinking alcohol. Reports from 7 refugee incentive workers and 17 representatives from 6 implementing agencies during an initial site visit indicated that unhealthy AOD use was associated with individual, family, and community consequences (injury, gender-based violence, diversion of livelihoods). Reports from the province of origin (Katanga, DRC) and host country (Zambia) have also found AOD use to be prevalent.

The proposed study will test an intervention package known as 'screening, brief intervention, and referral to treatment' (SBIRT). SBIRT systems are evidence-based for the treatment of unhealthy AOD use in non-humanitarian settings and can efficiently provide individuals with an appropriate level of care based on their symptom presentation and severity. For example, individuals with hazardous AOD use but without a more severe disorder and without mental health comorbidities may be best served by a brief intervention (BI); for many of these individuals, a full course of a psychotherapy may not be necessary (i.e., inefficient use of limited resources). On the other hand, individuals with more severe AOD disorder or mental health comorbidities likely require more comprehensive treatment. In this trial the investigators will provide BI or BI+psychotherapy commensurate with an individual's symptom presentation.

The interventions included in the SBIRT system are the Common Elements Treatment Approach-Brief Intervention (CETA-BI) and the full CETA psychotherapy (CETA). Previous randomized controlled trials have found CETA to be an effective treatment, including among refugees, for a range of mental and behavioral health problems, including depression, anxiety, trauma, and functional impairment. CETA has recently been tested in Zambia and found to also reduce unhealthy alcohol use in addition to mental health problems and intimate partner violence. CETA is a transdiagnostic approach, meaning that counselors trained in CETA are equipped with the ability to treat a range of co-occurring mental and behavioral health conditions. It was developed for use in low- and middle-income countries (LMIC) to facilitate lower cost and sustainability. CETA includes 9 cognitive behavioral elements found in most evidence-based psychological treatments. CETA is 6-12 weekly one-hour sessions with flexibility depending on symptom severity. CETA-BI combines motivational interviewing skills 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 and goal-setting; 4) understanding the primary reason for drinking; 5) skill building; and 6) referral for services. CETA-BI and CETA were previously found effective for AOD use and mental health problems within HIV care in Lusaka, Zambia. CETA-BI and CETA have significant potential for adaptation and implementation in refugee settings but a rigorous RCT adapting and testing them in an SBIRT stepped-care approach among refugees is warranted.

Being tested
SBIRT, Treatment as usual
Keywords
Alcohol Use Disorder, Substance Use Disorders, Depression, Anxiety, Trauma
Medical subject headings
Alcoholism, Substance-Related Disorders, Depression, Anxiety Disorders, Wounds and Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SBIRTBehavioural

    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 usualBehavioural

    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.

Study groups in NCT05471921
Study groupRoleWhat they receive
SBIRTExperimentalExperimental condition: Participants residing in the study community (displaced and host population) will receive Screening, Brief Intervention, and Referral to Treatment (SBIRT). The treatment will consist of brief intervention (CETA-BI) and full Common Elements Treatment Approach (CETA) depending on the severity of the participant's substance use.
Receives: Behavioral: SBIRT
Treatment as usualActive comparatorComparison condition: Participants residing in the study community (displaced and host population) will receive the current standard of treatment.
Receives: Behavioral: Treatment as usual

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Alcohol Use Disorders Identification Test (AUDIT) Score

    AUDIT is a 10-item measure of hazardous alcohol use with a possible range of 0-40 (total scale score). Higher scores are associated with more hazardous use.

    Measured: Baseline, 6-months, 12-months

Secondary outcomes (6)
  1. Change in Center for Epidemiologic Studies - Depression Scale (CES-D) Score

    The CES-D is a is a 20-item measure that asks individuals to rate how often over the past week they experienced symptoms associated with depression, such as restless sleep, poor appetite, and feeling lonely. Response options range from 0 to 3 for each item (0 = Rarely or None of the Time, 1 = Some or Little of the Time, 2 = Moderately or Much of the time, 3 = Most or Almost All the Time). Scores range from 0 to 60, with high scores indicating greater depressive symptoms.

    Measured: Baseline, 6-months, 12-months

  2. Change in Generalized Anxiety Disorder-7 Scale (GAD-7) Score

    The GAD-7 questionnaire is a seven-item, self-report anxiety questionnaire designed to assess the patient's health status. Scores of 0, 1 or 2 are given for experiencing symptoms 'not at all', for 'several days', for 'more than half the days' and for 'nearly every day', respectively. The scores are then totaled and presented from 0 to 21, with high scores indicating greater anxiety symptoms.

    Measured: Baseline, 6-months, 12-months

  3. Change in Harvard Trauma Questionnaire (HTQ)

    HTQ is a checklist that inquires about a variety of trauma events, as well as the emotional symptoms considered to be uniquely associated with trauma. The HTQ is a 39-item PTSD symptom scale with a possible range of 1-4 (average scale score). Higher scores are associated with greater PTSD symptom severity.

    Measured: Baseline, 6-months, 12-months

  4. Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST): Risk Score (Continuous Outcome)

    The ASSIST is a questionnaire that screens for all levels of problem or risky substance use in adults. The ASSIST consists of eight questions covering tobacco, alcohol, cannabis, cocaine, amphetamine-type stimulants (including ecstasy) inhalants, sedatives, hallucinogens, opioids and 'other drugs'. A risk score is provided for each substance, and a total risk score is calculated with a minimum score of 0 and a maximum score of 243. Higher scores are indicative of higher risk substance use.

    Measured: Baseline, 6-months, 12-months

  5. Number of Participants Who Had Any Substance Use in the Past 3 Months, Based on Responses to the ASSIST Questionnaire

    The ASSIST is a questionnaire that screens for all levels of problem or risky substance use in adults. The ASSIST consists of eight questions covering tobacco, alcohol, cannabis, cocaine, amphetamine-type stimulants (including ecstasy) inhalants, sedatives, hallucinogens, opioids and 'other drugs'. A risk score is provided for each substance, and a total risk score is calculated with a minimum score of 0 and a maximum score of 243. Higher scores are indicative of higher risk substance use.

    Measured: Baseline, 6-months, 12-months

  6. Sleep Scale for the Medical Outcomes Research Study

    The Medical Outcomes Study Sleep Scale includes 12 items assessing sleep disturbance, sleep adequacy, somnolence, quantity of sleep, snoring, and awakening short of breath or with a headache. The scores of the dimensions and of the sleep problem index were converted to a 0 to 100 scale, with higher scores reflecting more of the attribute implied by the name (e.g. greater sleep disturbance, greater adequacy of sleep).

    Measured: Baseline, 6-months, 12-months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jul 2022
  2. Study start26 Apr 2023
  3. Primary completion24 Feb 2025
  4. Study completion24 Feb 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
400 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05471921
Sponsor's protocol ID
AAAU0532
Status last verified
Jul 2026
First submitted
21 Jul 2022
Last updated
19 Aug 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Greene MC, Loongo H, Metz K, Shawa M, Mtongo N, Lukoma I, Chiluba P, Chibemba V, Kamono S, Mushabati N, Chibambula M, Watson K, Vaughan K, Demis L, Skavenski S, Murray LK, Ventevogel P, Busse A, Tol WA, Ezard N, Mwanza D, Lungu G, Kamanga M, Kane JC. Screening, brief intervention, and referral to treatment compared with treatment as usual for alcohol use in an integrated refugee settlement in Zambia: a hybrid, type 1, randomised controlled trial. Lancet Glob Health. 2026 Jul 23:103989. doi: 10.1016/j.langlo.2026.103989. Online ahead of print.

    PubMed 42492563

Questions about this trial

What is this clinical trial studying?

A study testing SBIRT and Treatment as usual in people with Alcohol and Substance-Related Mental Disorders, run by Columbia University at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States, Zambia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Alcohol Use Disorders Identification Test (AUDIT) Score (time frame: Baseline, 6-months, 12-months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05471921, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.

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