CHANGE Study: a pilot trial of a new psychological intervention for alcohol misuse and mental health in Ukraine
| ISRCTN | ISRCTN11369479 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11369479 |
| Secondary identifying numbers | 28853, 219468/Z/19/Z |
- Submission date
- 13/09/2023
- Registration date
- 20/09/2023
- Last edited
- 24/01/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
The CHANGE study is a pioneering research project taking place in Ukraine. A dedicated team of experts is committed to developing effective interventions that can make a positive impact on the lives of individuals struggling with harmful alcohol use. This study aims to explore a new transdiagnostic approach that targets both alcohol consumption and psychosocial well-being simultaneously.
Who can participate?
Men aged 18 years or above with a history of harmful alcohol consumption who live in Ukraine.
What does the study involve?
Participants are randomly allocated into a treatment group or a control group.
What are the possible benefits and risks of participating?
A team of professionals will tailor an intervention specifically to participants' needs, helping them reduce their alcohol consumption and enhance their psychosocial well-being. Throughout the study, participants will have access to free counseling sessions and resources that can assist them in their journey towards a healthier lifestyle. Participants will be making a significant contribution to the development of evidence-based interventions that can help countless individuals in the future in Ukraine and globally. As a token of appreciation, participants will be eligible for incentives and rewards for their active participation in the study. The risks of participating in the CHANGE study are minimal and not different from general risks for the public in Ukraine.
Where is the study run from?
1. London School of Hygiene and Tropical Medicine (LSHTM) (UK)
2. National University of Kyiv-Mohyla Academy (NaUKMA) (Ukraine)
When is the study starting and how long is it expected to run for?
January 2023 to June 2024
Who is funding the study?
NIHR–Wellcome Partnership for Global Health Research (UK)
Who is the main contact?
Dr Sergiy Bogdanov, s.bogdanov@ukma.edu.ua
Contact information
Principal Investigator
Godzenka Dmytra 2/4
Kyiv
01042
Ukraine
 ORCID ID |
0000-0001-8811-3453 |
|---|---|
| Phone | +38 (0)660304020 |
| s.bogdanov@ukma.edu.ua |
Study information
| Study design | Parallel-arm single-blind individual randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Community |
| Study type | Treatment |
| Participant information sheet | https://ukmaedu.sharepoint.com/:w:/s/CHANGEProjectteam/EepaOn5WXwtJuofw2zjOSCgBvj-7u3D6TcTSeF_FCDsPPQ?e=xEGeKb |
| Scientific title | A pilot randomized controlled trial of a psychological intervention for alcohol misuse and mental health comorbidities in war-affected populations in Ukraine |
| Study objectives | The new psychological intervention CHANGE and enhanced usual care reduced amount of alcohol consumption and symptoms of psychological stress better then enhanced usual care only |
| Ethics approval(s) |
1. Approved 13/06/2023, LSHTM Ethics (Keppel Street, London, WC1E 7HT, United Kingdom; +44 (0)20 76368636; ethics@lshtm.ac.uk), ref: 28853 2. Approved 14/06/2023, NaUKMA Commettee on Research Ethics (Skovorody str, 2, Kyiv, 04070, Ukraine; +38 (0)44 425 60 64; t.yurochko@ukma.edu.ua), ref: 2 from 14/06/2023 |
| Health condition(s) or problem(s) studied | Alcohol misuse and psychological stress |
| Intervention | 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 the WHO (Dua, Barbui, Clark, Fleischmann, Poznyak, Ommeren, et al., 2011; 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, behavioural activation, facing fears, and accessing social support. These elements have been recommended in recent WHO guidelines (Dua, Barbui, Clark, Fleischmann, Poznyak, van Ommeren, et al., 2011; 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 misuse. The CHANGE intervention is composed of three phases each of which includes two individual face-to-face sessions (approximately 90 minutes each). Allocation: Participants will be individually randomised to the trial arms after baseline assessment. The randomisation code will be generated by ODK (and sealed envelopes will be used). Outcome assessors will not be aware of the allocated intervention. Control group: Enhanced usual care (EUC) All participants in this research will receive EUC. EUC includes consultation with a community health care worker. Participants will be given an information pamphlet detailing available resources and information on reducing alcohol intake and managing psychological distress. The information sheet will be explained to participants by community health workers in the setting, after they have completed the baseline outcome assessment. The community health workers are independent from the outcome assessors and intervention facilitators. Treatment group: EUC with the CHANGE intervention The treatment group will receive enhanced usual care (EUC), as well as the CHANGE intervention. Outcome assessment: Baseline and 3-month follow-up (after randomisation). |
| Intervention type | Other |
| Primary outcome measure | PDHD (percentage days of heavy drinking) measured using a Timeline Followback (TLFB) at baseline and 3 months |
| Secondary outcome measures | 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 |
| Overall study start date | 01/01/2023 |
| Completion date | 30/06/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Male |
| Target number of participants | 60 |
| Key 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) |
| Key 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 |
| Date of first enrolment | 17/09/2023 |
| Date of final enrolment | 29/02/2024 |
Locations
Countries of recruitment
- Ukraine
Study participating centre
Kyiv
04070
Ukraine
Sponsor information
Charity
Gibbs Building
215 Euston Road
London
NW1 2BE
England
United Kingdom
| Phone | +44 (0)20 76118888 |
|---|---|
| m.zelenka@wellcome.org | |
| Website | https://wellcome.org |
Funders
Funder type
Charity
No information available
Results and Publications
| Intention to publish date | 17/01/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in publicly available repository |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The dataset generated during and/or analysed during the current study will be stored in a publicly available repository: LSHTM Data Compass (https://datacompass.lshtm.ac.uk). The data stored will be anonymised participant data that excludes information classed as internal, confidential, or highly confidential. Dates of availability are not known yet. Written consent was provided by all participants. |
Editorial Notes
24/01/2024: The following changes were made to the study record:
1. The recruitment end date was changed from 17/12/2023 to 29/02/2024.
2. The overall study end date was changed from 17/01/2024 to 30/06/2024.
31/10/2023: The sponsor email was updated.
14/09/2023: Study's existence confirmed by LSHTM Ethics.
