An interventional study of Empowerment Group Therapy in Depression NOS, sponsored by Charite University, Berlin, Germany. Recruiting at 1 site in Ukraine. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-03.
Sponsored by Charite University, Berlin, Germany · Not applicable, Interventional, and Treatment
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.
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.
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's planned enrollment of 55 is below the median of 84 across 6,720 interventional studies indexed under Depression.
Browse Depression studies →Charite University, Berlin, Germany is the lead sponsor of 836 studies on the registry; 129 are open to participants now.
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Exclusion Criteria:
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
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.
Feasibility of the intervention
Feasibility will be indexed by inclusion rate of participants to the study.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: Post-intervention (after completion of 10 group psychotherapy sessions; 10 to 11 weeks from baseline)
Stress, anxiety and depression
The Depression Anxiety Stress Scale (Nilges \& Essau, 2015) will be used to analyse symptoms of stress, anxiety and depression. The score ranges from 0 to 63, with higher scores indicating higher levels of depressive and anxiety symptoms.
Time frame: 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
The Patient Health Questionnaire - 9 (Kroenke, 2001) will be used to assess depressive symptoms. Scores range from 0 to 27. Higher scores indicate greater severity of depression.
Time frame: 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
The Posttraumatic Stress Disorder Checklist for DSM-5 (Blevins, 2015) will be used to analyse symptoms of PTSD. The symptom severity score ranges from 0 to 80 with higher scores indicating higher symptom levels.
Time frame: 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
The Somatic Symptom Scale-8 (Gierk 2013) will be used to assess somatic symptom burden. Scores range from 0 to 32, with higher scores indicating greater somatic symptom burden
Time frame: 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
The 36-Item Short Form Health Survey (Ware \& Sherbourne 1992) will be used to assess health-related quality of life. Each of the eight health domains in the SF-36 is scored on a 0 to 100 scale, where 0 represents the worst possible health status and 100 represents the best possible health status.
Time frame: 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)
Resilience
The Brief Resilience Scale (Smith 2009) will be used to assess the ability to bounce back or recover from stress. The scale consists of six items rated on a 5-point Likert scale. For interpretation, a mean score is calculated ranging from 1 to 5, with higher scores indicating greater resilience.
Time frame: 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)
Plan to share: Undecided
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Charite University, Berlin, Germany