Trial Outcomes & Findings for Effectiveness of an Evidence-based Stepped Care System for Alcohol and Other Drug Use Problems Among Congolese Refugees in Zambia (NCT NCT05471921)
NCT ID: NCT05471921
Last Updated: 2025-11-06
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
400 participants
Primary outcome timeframe
Baseline, 6-months, 12-months
Results posted on
2025-11-06
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
199
|
201
|
|
Overall Study
COMPLETED
|
157
|
153
|
|
Overall Study
NOT COMPLETED
|
42
|
48
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effectiveness of an Evidence-based Stepped Care System for Alcohol and Other Drug Use Problems Among Congolese Refugees in Zambia
Baseline characteristics by cohort
| Measure |
SBIRT
n=199 Participants
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.
|
Treatment as usual
n=201 Participants
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.
|
Total
n=400 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
36.8 Years
STANDARD_DEVIATION 12.3 • n=49 Participants
|
36.9 Years
STANDARD_DEVIATION 11.9 • n=50 Participants
|
36.9 Years
STANDARD_DEVIATION 12.1 • n=50 Participants
|
|
Sex: Female, Male
Female
|
55 Participants
n=49 Participants
|
58 Participants
n=50 Participants
|
113 Participants
n=50 Participants
|
|
Sex: Female, Male
Male
|
144 Participants
n=49 Participants
|
143 Participants
n=50 Participants
|
287 Participants
n=50 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=49 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=49 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=49 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
|
Race (NIH/OMB)
Black or African American
|
199 Participants
n=49 Participants
|
201 Participants
n=50 Participants
|
400 Participants
n=50 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=49 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=49 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=49 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
|
Nationality
Congolese
|
115 Participants
n=49 Participants
|
117 Participants
n=50 Participants
|
232 Participants
n=50 Participants
|
|
Nationality
Zambian
|
84 Participants
n=49 Participants
|
84 Participants
n=50 Participants
|
168 Participants
n=50 Participants
|
PRIMARY outcome
Timeframe: Baseline, 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.
Outcome measures
| Measure |
SBIRT
n=199 Participants
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.
|
Treatment as usual
n=201 Participants
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.
|
|---|---|---|
|
Change in Alcohol Use Disorders Identification Test (AUDIT) Score
Mean change from Baseline to 6 months
|
-12.6 score on a scale
Interval -14.3 to -11.0
|
-8.1 score on a scale
Interval -9.8 to -6.3
|
|
Change in Alcohol Use Disorders Identification Test (AUDIT) Score
Mean change from Baseline to 12 months
|
-13.8 score on a scale
Interval -15.5 to -12.1
|
-10.3 score on a scale
Interval -12.1 to -8.6
|
SECONDARY outcome
Timeframe: Baseline, 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.
Outcome measures
| Measure |
SBIRT
n=199 Participants
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.
|
Treatment as usual
n=201 Participants
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.
|
|---|---|---|
|
Change in Center for Epidemiologic Studies - Depression Scale (CES-D) Score
Mean change from Baseline to 6 months
|
-9.5 score on a scale
Interval -11.6 to -7.5
|
-5.8 score on a scale
Interval -7.9 to -3.7
|
|
Change in Center for Epidemiologic Studies - Depression Scale (CES-D) Score
Mean change from Baseline to 12 months
|
-8.9 score on a scale
Interval -11.0 to -6.8
|
-8.1 score on a scale
Interval -10.3 to -6.0
|
SECONDARY outcome
Timeframe: Baseline, 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.
Outcome measures
| Measure |
SBIRT
n=199 Participants
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.
|
Treatment as usual
n=201 Participants
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.
|
|---|---|---|
|
Change in Generalized Anxiety Disorder-7 Scale (GAD-7) Score
Mean change from Baseline to 6 months
|
-3.6 score on a scale
Interval -4.5 to -2.6
|
-2.1 score on a scale
Interval -3.0 to -1.2
|
|
Change in Generalized Anxiety Disorder-7 Scale (GAD-7) Score
Mean change from Baseline to 12 months
|
-3.5 score on a scale
Interval -4.4 to -2.6
|
-3.2 score on a scale
Interval -4.1 to -2.2
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
SBIRT
n=199 Participants
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.
|
Treatment as usual
n=201 Participants
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.
|
|---|---|---|
|
Change in Harvard Trauma Questionnaire (HTQ)
Mean change from Baseline to 6 months
|
-0.5 score on a scale
Interval -0.6 to -0.4
|
-0.4 score on a scale
Interval -0.5 to -0.3
|
|
Change in Harvard Trauma Questionnaire (HTQ)
Baseline to 12 months
|
-0.5 score on a scale
Interval -0.6 to -0.4
|
-0.5 score on a scale
Interval -0.6 to -0.4
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
SBIRT
n=199 Participants
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.
|
Treatment as usual
n=201 Participants
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.
|
|---|---|---|
|
Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST): Risk Score (Continuous Outcome)
Mean change from baseline to 6 months
|
-28.3 score on a scale
Interval -34.7 to -21.8
|
-23.0 score on a scale
Interval -29.5 to -16.4
|
|
Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST): Risk Score (Continuous Outcome)
Mean change from baseline to 12 months
|
-30.4 score on a scale
Interval -36.9 to -24.0
|
-26.1 score on a scale
Interval -32.6 to -19.5
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
SBIRT
n=199 Participants
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.
|
Treatment as usual
n=201 Participants
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.
|
|---|---|---|
|
Number of Participants Who Had Any Substance Use in the Past 3 Months, Based on Responses to the ASSIST Questionnaire
Baseline
|
60 Participants
|
55 Participants
|
|
Number of Participants Who Had Any Substance Use in the Past 3 Months, Based on Responses to the ASSIST Questionnaire
6 months
|
24 Participants
|
33 Participants
|
|
Number of Participants Who Had Any Substance Use in the Past 3 Months, Based on Responses to the ASSIST Questionnaire
12 months
|
18 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: Baseline, 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).
Outcome measures
Outcome data not reported
Adverse Events
SBIRT
Serious events: 8 serious events
Other events: 0 other events
Deaths: 0 deaths
Treatment as usual
Serious events: 1 serious events
Other events: 0 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
SBIRT
n=199 participants at risk
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.
|
Treatment as usual
n=201 participants at risk
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.
|
|---|---|---|
|
Infections and infestations
Hospitalization
|
2.0%
4/199 • Number of events 4 • Up to 12 months
|
0.00%
0/201 • Up to 12 months
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/199 • Up to 12 months
|
0.50%
1/201 • Number of events 1 • Up to 12 months
|
|
Social circumstances
Intimate partner violence
|
0.50%
1/199 • Number of events 1 • Up to 12 months
|
0.00%
0/201 • Up to 12 months
|
|
Surgical and medical procedures
Hospitalization
|
0.50%
1/199 • Number of events 1 • Up to 12 months
|
0.00%
0/201 • Up to 12 months
|
|
Infections and infestations
Illness
|
1.0%
2/199 • Number of events 2 • Up to 12 months
|
0.00%
0/201 • Up to 12 months
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place