Empowerment group therapy for Ukrainian adults with depression
The Effects of Empowerment Group Therapy on Ukrainian Adult Outpatients Located Inside the Country During the War
This pilot will try a culturally adapted Empowerment Group Therapy to see if it is acceptable and feasible for Ukrainian adults with depression affected by the war.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 55 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Charite University, Berlin, Germany Academic / other |
| Locations | 1 site (Kyiv, Kyiv Oblast) |
| Trial ID | NCT07048990 on ClinicalTrials.gov |
What this trial studies
This single-arm pilot will deliver a 10-session, depression-focused CBT group program adapted to Ukrainian culture to five groups of 10–14 outpatients (50–70 people) either in person or online. Participants complete self-report measures at baseline, after the 10–11 week intervention, and at a 4-week follow-up to collect preliminary effectiveness and retention data. Feasibility is measured primarily by participant retention and acceptability via questionnaires and qualitative feedback. The study also collects symptom measures for depression, anxiety, PTSD, stress, somatization, and quality of life to inform future trials.
Who should consider this trial
Good fit: Adults (18+) living in Ukraine since the start of the full-scale war who speak Ukrainian or Russian, can attend in-person or online sessions, and have at least moderate depression/anxiety/stress symptoms on the DASS-21 are ideal candidates.
Not a fit: People with schizophrenia, autism spectrum disorders, degenerative disorders, significant cognitive impairment, or active problematic use of alcohol or psychoactive substances are excluded and unlikely to benefit from this group program.
Why it matters
Potential benefit: If successful, this intervention could reduce depressive and stress-related symptoms and improve quality of life and resilience among conflict-affected Ukrainians.
How similar studies have performed: Group CBT and empowerment-style therapies have shown benefit for depression and psychosocial distress in diverse settings, but this specific Ukrainian cultural adaptation is newly applied and has limited prior outcome data.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Kyiv, Kyiv Oblast
- National Medical University Bogomolets — Kyiv, Kyiv Oblast, Ukraine (Recruiting)
Study contacts
- Study coordinator: Solveig Kemna, Dr. med.
- Email: solveig.kemna@charite.de
- Phone: +49 30 450 517 542
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.