National Medical University Bogomolets
Kyiv, Kyiv Oblast, Ukraine
Location status: Recruiting
NCT Number: NCT07048990
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Kyiv, Kyiv Oblast, Ukraine
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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).
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).
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).
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).
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)
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)
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)
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)
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)
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)
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.
Contact information is provided by the study sponsor or research team.
Charite University, Berlin, Germany
Other
The Effects of Empowerment Group Therapy on Ukrainian Adult Outpatients Located Inside the Country During the War
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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