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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN11369479

Enrollment

Registered

2023-09-20

Start date

2023-09-17

Completion date

Unknown

Last updated

2026-02-02

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

The CHANGE intervention is based on PM+. PM+ is a brief, psychological intervention based on cognitive behavioural therapy (CBT) techniques that are empirically supported and formally recommended by t

W. a Tol et al., 2013

WHO, 2013). PM+ was developed by the WHO and the University of New South Wales, Australia. The manual involves the following empirically supported elements: problem-solving plus stress management, beh

Tol et al., 2013). The CHANGE intervention is based on PM+ strategies to treat underlying symptoms of common mental disorders and has an additional psychological component that addresses alcohol misus

Eligibility

Sex/Gender

Male

Age

18 Years to 100 Years

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

Measure	Time 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. Psychological distress measured using a Mental Health Assessment Inventory (MHAI), psychological distress sub-scale at baseline and 3 months 4. Depression measured using a Mental Health Assessment Inventory (MHAI), psychological distress sub-scale at baseline and 3 months 5. Anxiety measured using a Mental Health Assessment Inventory (MHAI), psychological distress sub-scale at baseline and 3 months 6. PTSD measured using a Mental Health Assessment Inventory (MHAI), psychological distress sub-scale at baseline and 3 months 7. Functional disability measured using a Mental Health Assessment Inventory (MHAI), WHODAS sub-scale, psychological distress sub-scale at baseline and 3 months 8. Perpetration of intimate partner violence measured using a United Nations Multi-Country Study on Men and Violence at baseline and 3 months	—

Measure

Time 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. Psychological distress measured using a Mental Health Assessment Inventory (MHAI), psychological distress sub-scale at baseline and 3 months 4. Depression measured using a Mental Health Assessment Inventory (MHAI), psychological distress sub-scale at baseline and 3 months 5. Anxiety measured using a Mental Health Assessment Inventory (MHAI), psychological distress sub-scale at baseline and 3 months 6. PTSD measured using a Mental Health Assessment Inventory (MHAI), psychological distress sub-scale at baseline and 3 months 7. Functional disability measured using a Mental Health Assessment Inventory (MHAI), WHODAS sub-scale, psychological distress sub-scale at baseline and 3 months 8. Perpetration of intimate partner violence measured using a United Nations Multi-Country Study on Men and Violence at baseline and 3 months

—

Countries

Ukraine

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 7, 2026