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A learning health system for innovative, community-based mental health care delivery in Ukraine: an international, multi-stakeholder effort

EMHC - Evaluation of community-based Mental Health Centers in Ukraine: A multi-center observational study using mixed methods

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN61471084
Enrollment
400
Registered
2025-07-03
Start date
2025-08-04
Completion date
Unknown
Last updated
2026-05-04

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

Conditions

Evaluation of Mental Health Centers (new model of care) in Ukraine according to the RE- AIM-Framework including the dimensions reach, effectiveness, adoption, implementation, maintenance)

Interventions

Current methodology as of 16/01/2026: We will conduct a mixed method approach guided by the RE-AIM framework assessing the five dimensions reach, effectiveness, adoption, implementation, and mainten

Sponsors

University of Zurich
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: Current key inclusion criteria as of 16/01/2026: 1. Providers/health professionals working at the MHCs: We include all providers (all roles and functions) working at the MHC. 2. Provider/health professionals working in the communities where the MHCs are located: Existing cooperation/partnership with MHCs. 3. Patients: 3.1. Adults (age =18 years) who are resident of Ukraine 3.2. Receiving current treatment at the MHC 3.3. One to three sessions received at the MHC for the quantitative assessment; a minimum of 6 weeks of treatment received for the qualitative assessment (interviews) 3.4. Providing informed consent 3.5. Being able to complete assessments (no acute mental health condition including, but not limited to psychosis, alcohol intoxication, dementia) _____ Previous key inclusion criteria: 1. Providers/health professionals working at the MHCs: We include all providers (all roles and functions) working at the MHC. 2. Provider/health professionals working in the communities where the MHCs are located: Existing cooperation/partnership with MHCs. 3. Patients: 3.1. Adults (age =18 years) who are resident of Ukraine 3.2. Receiving current treatment at the MHC 3.3. A minimum of = 2 treatment sessions received at the MHC for the quantitative assessment; a minimum of 6 weeks of treatment received for the qualitative assessment (interviews) 3.4. Providing informed consent 3.5. Being able to complete assessments (no acute mental health condition including, but not limited to psychosis, alcohol intoxication, dementia)

Exclusion criteria

Exclusion criteria: Patients: Patients who cannot be reached on multiple attempts

Design outcomes

Primary

MeasureTime frame
Current primary outcome(s) as of 16/01/2026: 1. Reach will be assessed by capturing patient data about the total number, characteristics, and referral sources of patients receiving care at MHCs based on the center record data (secondary analysis). Center records and baseline assessment questionnaire will explore demographic and clinical characteristics of patients compared to those who are not receiving care in the center, using data from the control group (MAP study) as a reference. Patient interviews will be conducted to identify factors that hinder or support access to services. A follow-up assessment is planned to follow the completion of phases 1 and 2 of the evaluation, anticipated to occur within 1 to 2 years. 2. Effectiveness will be assessed through quantitative assessment of patient measuring patient symptoms and severity of specific mental health conditions using self-reported outcome measurements: PTSD by the Posttraumatic Stress Disorder Checklist (PCL-5), depression by the Patient Health Questionnaire 9 (PHQ- 9), anxiety by the Generalized Anxiety Disorder 7 (GAD-7), somatic symptoms by the Patient Health Questionnaire 15 (PHQ-15), alcohol use disorder by the Alcohol Use Disorders Identification Test (AUDIT). Health-related quality of life will be measured by the European Quality of Life 5 Dimensions (EQ-5D-5L) instrument and the visual analogue scale (EQ-VAS) and mental wellbeing by Short Warwick-Edinburgh Mental Wellbeing Scale (SWEMWBS). These assessments take place at baseline, follow-up 1 (after 3 months) and follow-up 2 (after 6 months). 3. Adoption will be evaluated at the MHC- and the community-level. Center records will capture the number, proportion and characteristics of MHCs and their affiliated providers/health professionals. For providers/health professionals working at the MHC, self-reported validated questionnaires will be completed: The Team Development Measure (TDM), the Mental Illness Clinicians’ Attitudes Scale (MICA-4), the Copen

Secondary

MeasureTime frame
Qualitative data and context-specific insights generated in workshops with key stakeholders after each phase of the evaluation was completed to inform about the results of the evaluation and to facilitate improvement in mental health care delivery.

Countries

Ukraine

Contacts

Public ContactMilo Alan Puhan
miloalan.puhan@uzh.ch+41 44 634 46 10

Outcome results

None listed

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