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Clinical Trials/ISRCTN10360385
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)

Registry
who.int
Start Date
January 30, 2023
End Date
July 1, 2025
Last Updated
2 years ago
Study Type
Interventional
Sex
Male

Investigators

Sponsor
IHR–Wellcome Partnership for Global Health Research

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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