Feasibility of Empowerment Group Therapy on Ukrainian Adult Outpatients

NCT07048990 | Recruiting

• 1 other identifier: EMPOWER_UA_ADULTS_2025
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

This single-arm pilot study aims to explore the feasibility and acceptability of the culturally adapted, Ukrainian version of the Empowerment Group Therapy (Wiechers, 2023) manual and accompanying workbook for the Ukrainian population affected by the ongoing war. Feasibility will be evaluated based on participant retention. Acceptability will be assessed through questionnaires and qualitative feedback. The study also gathers preliminary data on the effectiveness of the intervention by assessing changes in quality of life, stress, symptoms of anxiety, depression, PTSD, and somatization. Overall, it seeks to explore the relevance and impact of group-based resilience therapy in a conflict-affected setting.

Conditions

Depression NOS

Outcome Measures

Primary Outcomes (5)

• Feasibility of the intervention

  Feasibility will be indexed by inclusion rate of participants to the study.

  Post-Intervention (after completion of 10 group psychotherapy sessions; 10 to 11 weeks from baseline)

• Feasibility of the intervention

  Feasibility will be indexed by participants attendance of the group therapy sessions (\>80% of sessions).

  Post-Intervention (after completion of 10 group psychotherapy sessions; 10 to 11 weeks from baseline)

• Feasibility of the intervention

  Feasibility will be indexed by droup-out rate (\<20% of participants).

  Post-Intervention (after completion of 10 group psychotherapy sessions; 10 to 11 weeks from baseline)

• Acceptability of the intervention

  Acceptability will be assessed by the rate of intervention completion (\>80% complete all sessions).

  Post-intervention (after completion of 10 group psychotherapy sessions; 10 to 11 weeks from baseline)

• Acceptability of the intervention

  Acceptability will be assessed by using the Client Satisfaction Questionnaire (Attkisson \& Zwick, 1982).

  Post-intervention (after completion of 10 group psychotherapy sessions; 10 to 11 weeks from baseline)

Secondary Outcomes (6)

• Stress, anxiety and depression

  At baseline, post-intervention (after completion of 10 group psychotherapy sessions; 10 to 11 weeks from baseline), and follow-up (4 weeks after last group therapy session)

• Depressive symptoms

  At baseline, post-intervention (after completion of 10 group psychotherapy sessions; 10 to 11 weeks from baseline), and follow-up (4 weeks after last group therapy session)

• PTSD Symptoms

  At baseline, post-intervention (after completion of 10 group psychotherapy sessions; 10 to 11 weeks from baseline), and follow-up (4 weeks after last group therapy session)

• Somatic symptom burden

  At baseline, post-intervention (after completion of 10 group psychotherapy sessions; 10 to 11 weeks from baseline), and follow-up (4 weeks after last group therapy session)

• Health-related Quality of Life

  At baseline, post-intervention (after completion of 10 group psychotherapy sessions; 10 to 11 weeks from baseline), and follow-up (4 weeks after last group therapy session)

Study Arms (1)

CBT-based group therapy intervention "Empowerment"

EXPERIMENTAL

10 CBT-based psychotherapeutic group sessions will be held weekly, either in person or online, through trained psychiatrists or psychotherapists from the Department of Medical Psychology, Psychosomatic Medicine, and Psychotherapy at Bogomolets National Medical University. During the first group session, participants will receive the workbook "Empowerment" ("Опора та стійкість"), which is to be completed at home between sessions as homework. Each session will include an assessment of the participants' general current condition, their engagement in the psychotherapeutic interventions, group dynamics, and more.

Behavioral: Empowerment Group Therapy

Interventions

Empowerment Group Therapy BEHAVIORAL

Empowerment is a manualized, culturally sensitive treatment program. The treatment is based on a modular principle that transdiagnostically targets major symptom domains (e.g. stress, depression, anxiety), and can be flexibly adapted to individual mental health conditions of clients who participate in this program. The intervention is designed as a psychological group intervention for resource-limited settings and scalable for different formats (i.e. in-person, online, hybrid) to be feasible under the unstable conditions of war (e.g. missile attacks, power outrages). Key therapeutic elements are psychoeducation, emotion regulation strategies, problem solving and building coping skills. The activation of individual and culture-specific resources as well as building self-help skills are at focus of the treatment.

CBT-based group therapy intervention "Empowerment"

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Civilians
• years of age or older
• Residency in Ukraine at the onset of the full-scale war in Ukraine and at the time of the study
• Ability to participate in in-person or online sessions
• Ability to participate in online sessions, including communication via smartphone chat
• Speaks Ukrainian or Russian
• Presence of depression, anxiety, stress according to DSM-5 criteria, or psychological distress directly or indirectly caused by the war (other conditions may be included if deemed appropriate by a physician)
• Moderate severity of symptoms on the depression, anxiety, or stress subscale of the DASS-21
• Anyone who, upon being placed on the waiting list, recognizes a need for help and support is eligible to participate
• Signed informed consent form

You may not qualify if:

• Lack of informed consent
• Diagnosis of schizophrenia, autism spectrum disorders, degenerative disorders, or significant cognitive impairments
• Use of psychoactive substances and alcohol
• Acute risk of suicide
• Ongoing psychotherapy or psychotherapy within the past 3 months
• Psychopharmacological treatment (at the discretion of the therapist during screening)
• Current inpatient treatment
• Incomplete screening questionnaires

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• Ludwig-Maximilians - University of Munich: collaborator
• Bogomolets National Medical University: collaborator

Study Sites (1)

National Medical University Bogomolets

Kyiv, Kyiv Oblast, Ukraine

RECRUITING

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Central Study Contacts

Solveig Kemna, Dr. med.

CONTACT

+49 30 450 517 542; solveig.kemna@charite.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident/research associate

Study Record Dates

• First Submitted: June 18, 2025
• First Posted: July 3, 2025
• Study Start: November 5, 2024
• Primary Completion: August 1, 2025
• Study Completion: September 1, 2025
• Last Updated: July 3, 2025

Record last verified: 2025-06

Locations

UA (1)