Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT05471921 |
| Other study ID # |
AAAU0532 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 26, 2023 |
| Est. completion date |
June 30, 2025 |
Study information
| Verified date |
April 2024 |
| Source |
Columbia University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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.
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.
