Feasibility of Empowerment Group Therapy on Ukrainian Adult Outpatients

Charité University Medicine Berlin

Status: Enrolling

Conditions: Depression NOS

Treatments: Behavioral: Empowerment Group Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07048990

EMPOWER_UA_ADULTS_2025

Details and patient eligibility

About

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.

Full description

The investigators will identify eligible participants at the Bogomolets outpatient department. An eligibility screening conducted in person to ensure the inclusion criteria are met. All participants must sign an informed consent form after receiving written and verbal study information. Participants will carry out self-reported measurements at baseline (T0), after the intervention phase of 10-11 weeks (T1), and at follow-up at 4 weeks after the last intervention session (T2). The participants receive ten group therapy sessions, which are delivered in an in-person or digital setting. The intervention will be provided for five groups, each comprised of 10 to 14 participants, including overall 50 to 70 persons.

The Empowerment intervention (Wiechers 2023) is a depression-specific CBT-based group therapy. It is based on 16 modules which can be selected according to the needs of the group. The sessions start with a mindfulness or breathing exercise, and focus on psychoeducation and behavioral activation. The manual was culturally adapted to the current Ukrainian context and translated into Ukrainian.

The data management plan includes standard procedures for data-handling such as using anonymized identification codes for patient data. Besides, the participants have the right to access their data, and the right to claim an annihilation. The data is being saved in an online database, only allowing researchers involved in the study to access the data.

Enrollment: 55 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Civilians
• 18 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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55 participants in 1 patient group

CBT-based group therapy intervention "Empowerment"

Experimental group

Description:

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.

Treatment:

Behavioral: Empowerment Group Therapy