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

A Randomized Controlled Trial (RCT) of a psychological intervention for alcohol misuse and mental health comorbidities in conflict-affected populations in Ukraine

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN14881856
Enrollment
500
Registered
2024-07-05
Start date
2024-06-25
Completion date
Unknown
Last updated
2026-06-08

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

Conditions

Alcohol misuse and psychological stress Mental and Behavioural Disorders

Interventions

Sponsors

London School of Hygiene & Tropical Medicine
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 90 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
PDHD (percentage days of heavy drinking) measured using a Timeline Followback (TLFB)  at baseline and 3 months

Secondary

MeasureTime frame
1. PDA (percentage of days abstinent) measured using a Timeline Followback (TLFB) at baseline and 3 months 2. Alcohol misuse  measured using the Alcohol Use Disorders Identification Test (AUDIT) at baseline and 3 months 3. Alcohol misuse  measured using the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)  at baseline and 3 months 4. Psychological distress measured using a Kessler-10 (K-10) at baseline and 3 months 5. Depression measured using a Mental Health Assessment Inventory (MHAI), Depression sub-scale at baseline and 3 months 6. Anxiety measured using a Mental Health Assessment Inventory (MHAI), anxiety sub-scale at baseline and 3 months 7. PTSD measured using a Mental Health Assessment Inventory (MHAI), PTSD sub-scale at baseline and 3 months 8. Functional disability measured using a Mental Health Assessment Inventory (MHAI), WHODAS sub-scale at baseline and 3 months 9. Perpetration of intimate partner violence measured using a United Nations Multi-Country Study on Men and Violence  at baseline and 3 months 10. Health economics indicators measured using a EQ-5D-5L, Subjective wellbeing (happiness and life satisfaction) and OxCAP-MH at baseline and 3 months

Countries

Ukraine

Contacts

Public ContactViktoria Kachay
v.kachay@ukma.edu.ua+38(093)8171801

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jun 11, 2026