Depression NOSNCT07048990
Feasibility of Empowerment Group Therapy on Ukrainian Adult Outpatients
A study testing Empowerment Group Therapy in people with Depression NOS, run by Charite University, Berlin, Germany at 1 site in Ukraine.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression NOS
- What is being tested?
- Empowerment Group Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUkraine
- Study dates
- 5 Nov 2024to Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ukraine1 site, 1 recruiting
- Recruiting
National Medical University Bogomolets
Kyiv, Kyiv Oblast
Oleg Sozontovych Chaban, MD, PhD, Professor, ocs@ukr.net
About this study
Official title: The Effects of Empowerment Group Therapy on Ukrainian Adult Outpatients Located Inside the Country During the War
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.
Read the detailed 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.
- Conditions
- Depression NOS
- Being tested
- Empowerment Group Therapy
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empowerment Group TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Empowerment Group Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of the intervention
Feasibility will be indexed by inclusion rate of participants to the study.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Post-intervention (after completion of 10 group psychotherapy sessions; 10 to 11 weeks from baseline)
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2025
- Study start5 Nov 2024
- Primary completionAug 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression NOSStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Ludwig-Maximilians - University of Munich, Bogomolets National Medical University
- Responsible party
- Principal investigator, Solveig Kemna, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07048990
- Sponsor's protocol ID
- EMPOWER_UA_ADULTS_2025
- Status last verified
- Jun 2025
- First submitted
- 18 Jun 2025
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Empowerment Group Therapy on Ukrainian Adult Outpatients Located Inside the Country During the War
- ClinicalTrials.gov ID
- NCT07048990
- Acronym / sponsor ID
- EMPOWER_UA_ADULTS_2025
- Conditions
- Depression NOS
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Ludwig-Maximilians - University of Munich, Bogomolets National Medical University
- Study start
- 5 Nov 2024 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 3 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CBT-based group therapy intervention "Empowerment" | Experimental | Behavioral: Empowerment Group Therapy10 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Empowerment Group TherapyEmpowerment 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. | Behavioural | CBT-based group therapy intervention "Empowerment" |
Primary outcome
Feasibility of the intervention
Time frame: Post-Intervention (after completion of 10 group psychotherapy sessions; 10 to 11 weeks from baseline)
Feasibility will be indexed by inclusion rate of participants to the study.
Feasibility of the intervention
Time frame: Post-Intervention (after completion of 10 group psychotherapy sessions; 10 to 11 weeks from baseline)
Feasibility will be indexed by participants attendance of the group therapy sessions (>80% of sessions).
Feasibility of the intervention
Time frame: Post-Intervention (after completion of 10 group psychotherapy sessions; 10 to 11 weeks from baseline)
Feasibility will be indexed by droup-out rate (<20% of participants).
Acceptability of the intervention
Time frame: Post-intervention (after completion of 10 group psychotherapy sessions; 10 to 11 weeks from baseline)
Acceptability will be assessed by the rate of intervention completion (>80% complete all sessions).
Acceptability of the intervention
Time frame: Post-intervention (after completion of 10 group psychotherapy sessions; 10 to 11 weeks from baseline)
Acceptability will be assessed by using the Client Satisfaction Questionnaire (Attkisson \& Zwick, 1982).
6 secondary outcomes
Stress, anxiety and 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)
Depressive 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)
PTSD 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)
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
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
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Empowerment Group Therapy in people with Depression NOS, run by Charite University, Berlin, Germany at 1 site in Ukraine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Solveig Kemna, Dr. med. (+49 30 450 517 542, solveig.kemna@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the intervention (time frame: Post-Intervention (after completion of 10 group psychotherapy sessions; 10 to 11 weeks from baseline)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2025; AzTrials last refreshed its copy on 8 Nov 2026.