CHANGE Study: a pilot trial of a new psychological intervention for alcohol misuse and mental health in Ukraine

Not Applicable

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

• Registration Number: ISRCTN11369479
• Lead Sponsor: IHR–Wellcome Partnership for Global Health Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-09-20
• Last Update Posted: 5 February 2024
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: Male
• Target Recruitment: 60

Inclusion Criteria

1. Adult men (aged >18 years)
2. Alcohol Use Disorder Identification Test (AUDIT) score 8-19 (Saunders et al., 1993)
3. Elevated levels of psychological distress (Kessler Psychological Distress Scale (ten-item version) (K10 = 16) (Kessler et al., 2002)

Exclusion Criteria

1. Men with possible alcohol dependence (AUDIT score =20)
2. Imminent risk of suicide/other life-threatening risk, acute medical conditions
3. Signs of severe mental disorders such as psychosis (this will be screened by a trained assessor which will refer the participant to a psychiatrist or counsellor if observable signs of severe mental disorders are detected)
4. Signs of severe cognitive impairment (e.g., severe intellectual disability or dementia)
5. Has received formalized brief psychological interventions (e.g., PM+, CETA) or any alcohol-focused treatment (e.g., AA) in the previous year

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