ISRCTN10360385
Active, Not Recruiting
N/A
A randomized controlled trial of a psychological intervention for alcohol misuse and mental health comorbidities in conflict-affected populations in Uganda
IHR–Wellcome Partnership for Global Health Research0 sites500 target enrollmentJanuary 30, 2023
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- IHR–Wellcome Partnership for Global Health Research
- Enrollment
- 500
- Status
- Active, Not Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
2024 Protocol article in https://doi.org/10.1186/s13063-024-07980-7 (added 28/02/2024)
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Adult south Sudanese men (\>18 years) with a refugee status
- •2\. Alcohol Use Disorder Identification Test (AUDIT score) between 8 and 20 (Saunders, Aasland, Babor, de la Fuente, et al., 1993\)
- •3\. Elevated levels of psychological distress (Kessler Psychological Distress Scale (10\-item version) (K10\>20\) (Kessler et al., 2010\)
- •4\. Speak English and/or Juba Arabic
Exclusion Criteria
- •Current exclusion criteria as of 26/05/2023:
- •1\. Adult south Sudanese men (\>18 years) with a refugee status
- •2\. Alcohol Use Disorder Identification Test (AUDIT score \<20\) or no alcohol dependence (AUDIT score \<8\) (Saunders, Aasland, Babor, de la Fuente, et al., 1993\)
- •3\. Elevated levels of psychological distress (Kessler Psychological Distress Scale (10\-item version) (K10\>20\) (Kessler et al., 2010\)
- •4\. Speak English and/or Juba Arabic
- •5\. Have previously received PM\+.
- •6\. Have been in the camp for less than three months, given that new arrivals take 2 to 3 months to relocate (i.e. receive land and refugee determination status), and the first three months are more likely to be in acute stages of distress.
- •Previous exclusion criteria as of 25/04/2023:
- •1\. Men with possible alcohol dependence (AUDIT score \=20\).
- •2\. Imminent risk of suicide/other life\-threatening risk, acute medical conditions assessed through three questions related to suicide (i.e., ‘in the past month, have you had serious thoughts or a plan to end your life?’, what actions have you taken to end your life? And do you plan to end your life in the next 2 weeks?). These participants will be referred to a psychiatric community officer (PCO).
Outcomes
Primary Outcomes
Not specified
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