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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05471921
Enrollment
400
Registered
2022-07-25
Start date
2023-04-26
Completion date
2025-02-24
Last updated
2026-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol and Substance-Related Mental Disorders

Keywords

Alcohol Use Disorder, Substance Use Disorders, Depression, Anxiety, Trauma

Brief 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.

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.

Interventions

BEHAVIORALSBIRT

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.

BEHAVIORALTreatment as usual

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.

Sponsors

Columbia University
Lead SponsorOTHER
Elrha
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

Participants will be randomized to SBIRT or treatment as usual (TAU) control. The Research Assistant (RA) will allocate participants to study conditions using a series of sealed, opaque envelopes. RAs and data analysts will be blinded. Participants will be notified immediately about the result of the randomization.

Eligibility

Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Change in Alcohol Use Disorders Identification Test (AUDIT) ScoreBaseline, 6-months, 12-monthsAUDIT 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.

Secondary

MeasureTime frameDescription
Change in Center for Epidemiologic Studies - Depression Scale (CES-D) ScoreBaseline, 6-months, 12-monthsThe 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.
Change in Generalized Anxiety Disorder-7 Scale (GAD-7) ScoreBaseline, 6-months, 12-monthsThe 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.
Change in Harvard Trauma Questionnaire (HTQ)Baseline, 6-months, 12-monthsHTQ 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.
Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST): Risk Score (Continuous Outcome)Baseline, 6-months, 12-monthsThe 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.
Number of Participants Who Had Any Substance Use in the Past 3 Months, Based on Responses to the ASSIST QuestionnaireBaseline, 6-months, 12-monthsThe 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.
Sleep Scale for the Medical Outcomes Research StudyBaseline, 6-months, 12-monthsThe 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).

Countries

United States, Zambia

Contacts

PRINCIPAL_INVESTIGATORJeremy Kane, PhD

Columbia University

PRINCIPAL_INVESTIGATORClaire Greene, PhD

Columbia University

PRINCIPAL_INVESTIGATORMuzi Kamanga

Women in Law and Development in Africa (WiLDAF)

PRINCIPAL_INVESTIGATORHenry Loongo, PhD

CARE Zambia

Participant flow

Participants by arm

ArmCount
SBIRT
Experimental 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. SBIRT: 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.
199
Treatment as usual
Comparison condition: Participants residing in the study community (displaced and host population) will receive the current standard of treatment. Treatment as usual: 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.
201
Total400

Baseline characteristics

CharacteristicTreatment as usualTotalSBIRT
Age, Continuous36.9 Years
STANDARD_DEVIATION 11.9
36.9 Years
STANDARD_DEVIATION 12.1
36.8 Years
STANDARD_DEVIATION 12.3
Nationality
Congolese
117 Participants232 Participants115 Participants
Nationality
Zambian
84 Participants168 Participants84 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
201 Participants400 Participants199 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
0 Participants0 Participants0 Participants
Sex: Female, Male
Female
58 Participants113 Participants55 Participants
Sex: Female, Male
Male
143 Participants287 Participants144 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 1993 / 201
other
Total, other adverse events
0 / 1990 / 201
serious
Total, serious adverse events
8 / 1991 / 201

Outcome results

Primary

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.

Time frame: Baseline, 6-months, 12-months

ArmMeasureGroupValue (MEAN)
SBIRTChange in Alcohol Use Disorders Identification Test (AUDIT) ScoreMean change from Baseline to 6 months-12.6 score on a scale
SBIRTChange in Alcohol Use Disorders Identification Test (AUDIT) ScoreMean change from Baseline to 12 months-13.8 score on a scale
Treatment as usualChange in Alcohol Use Disorders Identification Test (AUDIT) ScoreMean change from Baseline to 6 months-8.1 score on a scale
Treatment as usualChange in Alcohol Use Disorders Identification Test (AUDIT) ScoreMean change from Baseline to 12 months-10.3 score on a scale
Secondary

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.

Time frame: Baseline, 6-months, 12-months

ArmMeasureGroupValue (MEAN)
SBIRTAlcohol, Smoking, and Substance Involvement Screening Test (ASSIST): Risk Score (Continuous Outcome)Mean change from baseline to 6 months-28.3 score on a scale
SBIRTAlcohol, Smoking, and Substance Involvement Screening Test (ASSIST): Risk Score (Continuous Outcome)Mean change from baseline to 12 months-30.4 score on a scale
Treatment as usualAlcohol, Smoking, and Substance Involvement Screening Test (ASSIST): Risk Score (Continuous Outcome)Mean change from baseline to 6 months-23.0 score on a scale
Treatment as usualAlcohol, Smoking, and Substance Involvement Screening Test (ASSIST): Risk Score (Continuous Outcome)Mean change from baseline to 12 months-26.1 score on a scale
Secondary

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.

Time frame: Baseline, 6-months, 12-months

ArmMeasureGroupValue (MEAN)
SBIRTChange in Center for Epidemiologic Studies - Depression Scale (CES-D) ScoreMean change from Baseline to 6 months-9.5 score on a scale
SBIRTChange in Center for Epidemiologic Studies - Depression Scale (CES-D) ScoreMean change from Baseline to 12 months-8.9 score on a scale
Treatment as usualChange in Center for Epidemiologic Studies - Depression Scale (CES-D) ScoreMean change from Baseline to 6 months-5.8 score on a scale
Treatment as usualChange in Center for Epidemiologic Studies - Depression Scale (CES-D) ScoreMean change from Baseline to 12 months-8.1 score on a scale
Secondary

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.

Time frame: Baseline, 6-months, 12-months

ArmMeasureGroupValue (MEAN)
SBIRTChange in Generalized Anxiety Disorder-7 Scale (GAD-7) ScoreMean change from Baseline to 6 months-3.6 score on a scale
SBIRTChange in Generalized Anxiety Disorder-7 Scale (GAD-7) ScoreMean change from Baseline to 12 months-3.5 score on a scale
Treatment as usualChange in Generalized Anxiety Disorder-7 Scale (GAD-7) ScoreMean change from Baseline to 6 months-2.1 score on a scale
Treatment as usualChange in Generalized Anxiety Disorder-7 Scale (GAD-7) ScoreMean change from Baseline to 12 months-3.2 score on a scale
Secondary

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.

Time frame: Baseline, 6-months, 12-months

ArmMeasureGroupValue (MEAN)
SBIRTChange in Harvard Trauma Questionnaire (HTQ)Mean change from Baseline to 6 months-0.5 score on a scale
SBIRTChange in Harvard Trauma Questionnaire (HTQ)Baseline to 12 months-0.5 score on a scale
Treatment as usualChange in Harvard Trauma Questionnaire (HTQ)Mean change from Baseline to 6 months-0.4 score on a scale
Treatment as usualChange in Harvard Trauma Questionnaire (HTQ)Baseline to 12 months-0.5 score on a scale
Secondary

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.

Time frame: Baseline, 6-months, 12-months

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
SBIRTNumber of Participants Who Had Any Substance Use in the Past 3 Months, Based on Responses to the ASSIST QuestionnaireBaseline60 Participants
SBIRTNumber of Participants Who Had Any Substance Use in the Past 3 Months, Based on Responses to the ASSIST Questionnaire6 months24 Participants
SBIRTNumber of Participants Who Had Any Substance Use in the Past 3 Months, Based on Responses to the ASSIST Questionnaire12 months18 Participants
Treatment as usualNumber of Participants Who Had Any Substance Use in the Past 3 Months, Based on Responses to the ASSIST QuestionnaireBaseline55 Participants
Treatment as usualNumber of Participants Who Had Any Substance Use in the Past 3 Months, Based on Responses to the ASSIST Questionnaire6 months33 Participants
Treatment as usualNumber of Participants Who Had Any Substance Use in the Past 3 Months, Based on Responses to the ASSIST Questionnaire12 months22 Participants
Secondary

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).

Time frame: Baseline, 6-months, 12-months

Source: ClinicalTrials.gov · Data processed: Aug 20, 2026