A randomized controlled trial on alcohol misuse and associated adversities among conflict-affected populations

Not Applicable

• Conditions: Mental health comorbidities (alcohol misuse, depression, anxiety and post-traumatic stress disorders); Mental and Behavioural Disorders

• Registration Number: ISRCTN10360385
• Lead Sponsor: IHR–Wellcome Partnership for Global Health Research

Brief Summary

2024 Protocol article in https://doi.org/10.1186/s13063-024-07980-7 (added 28/02/2024)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-01-30
• Last Update Posted: 11 March 2024
• Study Completion: 2025-07-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: Male
• Target Recruitment: 500

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.

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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).
3. Signs of severe mental disorders such as psychosis and/or severed cognitive impairment (e.g. severe intellectual disability or dementia). This will be assessed using a checklist with lists of observable signs of severe mental disorders or severe cognitive impairment such as participant not understanding questions, presenting with confused speech, appearing extremely fidgety or nervous, limited communication skills, etc).
4. Men who have previously received the PM+ intervention.

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Previous exclusion criteria:

1. Men with possible alcohol dependence (AUDIT score =20). A validation study of the K10 in Uganda is currently being finalised, so the cut-off score may be slightly adjusted depending on the findings.
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).
3. Signs of severe mental disorders such as psychosis and/or severed cognitive impairment (e.g. severe intellectual disability or dementia). This will be assessed using a checklist with lists of observable signs of severe mental disorders or severe cognitive impairment such as participant not understanding questions, presenting with confused speech, appearing extremely fidgety or nervous, limited communication skills, etc)

Study & Design

• Study Type: Interventional
• Study Design: Not specified