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

A pilot randomized control trial of a psychological intervention for alcohol misuse and mental health comorbidities in conflict-affected populations in Uganda

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN16388582
Enrollment
60
Registered
2023-05-30
Start date
2022-10-10
Completion date
Unknown
Last updated
2024-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mental health comorbidities including alcohol misuse, depression, anxiety and post-traumatic stress disorders Mental and Behavioural Disorders

Interventions

South Sudanese refugee men living in the Rhino settlement in Northern Uganda will be recruited from households within previously selected villages on the basis that no previous HealthRight Internation

Sponsors

NIHR–Wellcome Partnership for Global Health Research
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1. Adult South Sudanese men (aged =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 =16) (Kessler et al., 2010) 4. Speak English and/or Juba Arabic

Exclusion criteria

Exclusion criteria: 1. Men with possible alcohol dependence (AUDIT score =20), or no alcohol dependence (AUDIT score <8). 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

MeasureTime frame
The percentage of days abstinent at the 3-month outcome assessment, measured using the timeline follow-back assessment (TLFB) at baseline and 3 months

Secondary

MeasureTime frame
Measured at the 3-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 and 3 months 2. Psychological distress measured using the Kessler Psychological Distress Scale (K10) at baseline and 3 months 3. Depression measured using the Patient Health Questionnaire-9 (PHQ-9) at baseline and 3 months 4. Anxiety measured using the Hopkins Symptom Checklist (HSCL-A) at baseline and 3 months 5. Post-traumatic stress disorder (PTSD) measured using PTSD Checklist (PCL-6) at baseline and 3 months 6. Functional disability measured using WHO Disability Assessment Schedule (WHODAS 2.0), 12-item, interviewer-administered version at baseline and 3 months 7. Perpetration of intimate partner violence by drinker, measured using the United Nations Multi-Country Study instrument at baseline and 3 months 8. Quality of life measured using the EQ-5D-5L and the Oxford CAPabilities questionnaire-Mental Health (OxCAP-MH) at baseline and 3 months Other outcomes: 1. Demographic data collected during participant screening 2. Trauma exposure measured using the Harvard Trauma Questionnaire at baseline and 3 months 3. Use of local substances measured using ASSIST at baseline and 3 months 4. Subjective wellbeing measured using Organisation for Economic Co-operation and Development (OECD) guidelines at baseline and 3 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 qualit

Countries

Uganda

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026