Clinical trial NCT05471921: Effectiveness of an Evidence-based Stepped Care System for Alcohol and Other Drug Use Problems Among Congolese Refugees in Zambia
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol and Substance-Related Mental Disorders
Keywords: Alcohol Use Disorder
Substance Use Disorders
Depression
Anxiety
Trauma
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Elrha
First posted: 2022-07-25
Enrollment: 400
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Difference in change in Alcohol Use Disorders Identification Test (AUDIT) score
timeFrame: Baseline, 6-months, 12-months
Secondary outcomes:
measure: Center for Epidemiologic Studies - Depression scale (CES-D)
timeFrame: Baseline, 6-months, 12-months
measure: Generalized Anxiety Disorder-7 scale (GAD-7)
timeFrame: Baseline, 6-months, 12-months
measure: Harvard Trauma Questionnaire (HTQ)
timeFrame: Baseline, 6-months, 12-months
measure: Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST)
timeFrame: Baseline, 6-months, 12-months
measure: Sleep Scale for the Medical Outcomes Research Study
timeFrame: Baseline, 6-months, 12-months
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University
state: New York
city: Nchelenge
country: Zambia
facility: Mantapala Refugee Settlement
state: Luapula
Study officials:
affiliation: Columbia University
name: Jeremy Kane, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Columbia University
name: Claire Greene, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Women in Law and Development in Africa (WiLDAF)
name: Muzi Kamanga
role: PRINCIPAL_INVESTIGATOR
affiliation: CARE Zambia
name: Henry Loongo, PhD
role: PRINCIPAL_INVESTIGATOR
References: