Mental health comorbidities (alcohol misuse, depression, anxiety and post-traumatic stress disorders) Mental and Behavioural Disorders
Conditions
Interventions
South Sudanese refugee men living in Rhino settlement in Northern Uganda will be recruited from households within previously identified villages. A total of 500 participants will be randomised. Random
Sponsors
NIHR–Wellcome Partnership for Global Health Research
Eligibility
Sex/Gender
Male
Inclusion 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
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) (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). 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. _____ 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage days abstinent at the 3 months’ outcome assessment, measured through the timeline follow-back assessment (TLFB) at baseline, 3 and 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Measured at the 3- and 12-month follow-up: 1. Alcohol misuse/remission measured using the Alcohol Use Disorders Identification Test (AUDIT); Alcohol, Smoking and Substance Involvement Screening Tool (ASSIST); and the TLFB assessment at baseline, 3 and 12 months 2. Psychological distress measured using the Kessler Psychological Distress Scale (K10) at baseline, 3 and 12 months 3. Depression measured using the Patient Health Questionnaire-9 (PHQ-9) at baseline, 3 and 12 months 4. Anxiety measured using the Hopkins Symptom Checklist (HSCL-A) at baseline, 3 and 12 months 5. Post-traumatic stress disorder (PTSD) measured using PTSD Checklist (PCL-6) at baseline, 3 and 12 months 6. Functional disability measured using WHO Disability Assessment Schedule (WHODAS 2.0), 12-item, interviewer-administered version at baseline, 3 and 12 months 7. Perpetration of intimate partner violence by drinker, measured using the United Nations Multi-Country Study instrument at baseline, 3 and 12 months 8. Quality of life measured using the EQ-5D-5L and the Oxford CAPabilities questionnaire-Mental Health (OxCAP-MH) at baseline, 3 and 12 months Other outcomes study: 1. Demographic data collected during participant screening 2. Trauma exposure measured using the Harvard Trauma Questionnaire at baseline, 3 and 12 months 3. Use of local substances measured using ASSIST at baseline, 3 and 12 months 4. Subjective wellbeing measured using Organisation for Economic Co-operation and Development (OECD) guidelines at baseline, 3 and 12 months 5. Treatment fidelity measured using audio recordings and checklists at the end of the intervention delivery 6. Methodological trial procedures using administrative data collected via participant tracking sheets throughout the trial 7. Feasibility measured using qualitative interviews at 3 months 8. Acceptability measured using qualitative interviews at 3 months 9. Appropriateness and dose, measured using administrative data collected via participant tracking d | — |
Countries
Uganda
Contacts
Public ContactCatharina van der Boor
Outcome results
None listed