CHANGE: A randomized controlled trial of a psychological intervention for alcohol misuse and mental health comorbidities in conflict-affected populations in Ukraine

Not Applicable

• Conditions: Mental and Behavioural Disorders; Alcohol misuse and psychological stress

• Registration Number: ISRCTN14881856
• Lead Sponsor: ondon School of Hygiene & Tropical Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-05
• Last Update Posted: 2 September 2024
• Study Completion: 2026-01-30

Recruitment & Eligibility

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

Inclusion Criteria

1. Adult men (>18 years)
2. Alcohol Use Disorder Identification Test (AUDIT) score 8-19 (Saunders, Aasland, Babor, de la Fuente, et al., 1993)
3. Elevated levels of psychological distress (Kessler Psychological Distress Scale (ten item version) (K10>16) (Kessler et al., 2010).
4. Speak Ukrainian or Russian

Exclusion Criteria

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 last month have you had thoughts about suicide? (harming another person)/ or a suicide plan? (a plan to harm another person). Do you have ways to carry out this plan?/Have you tried to kill yourself in the past month? (to kill or harm another person). These participants will be referred to a psychiatrist.
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. Has received formalized brief psychological interventions (e.g., PM+, CETA) in the previous year
5. Has received any forms of any substance use treatment (e.g., AA, detoxication, replacement therapy programs) in their lifetime
6. Men who are actively involved in military action
7. Residence outside of Ukraine

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
PDHD (percentage days of heavy drinking) measured using a Timeline Followback (TLFB)  at baseline and 3 months