Feasibility of Empowerment Group Therapy on Ukrainian Adult Outpatients

Официальное название

The Effects of Empowerment Group Therapy on Ukrainian Adult Outpatients Located Inside the Country During the War

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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 und

Первичные конечные точки

• Feasibility of the intervention [Срок оценки: Post-Intervention (after completion of 10 group psychotherapy sessions; 10 to 11 weeks from baseline)]
• Feasibility of the intervention [Срок оценки: Post-Intervention (after completion of 10 group psychotherapy sessions; 10 to 11 weeks from baseline)]
• Feasibility of the intervention [Срок оценки: Post-Intervention (after completion of 10 group psychotherapy sessions; 10 to 11 weeks from baseline)]
• Acceptability of the intervention [Срок оценки: Post-intervention (after completion of 10 group psychotherapy sessions; 10 to 11 weeks from baseline)]
• Acceptability of the intervention [Срок оценки: Post-intervention (after completion of 10 group psychotherapy sessions; 10 to 11 weeks from baseline)]

Вторичные конечные точки (6)

• Stress, anxiety and depression [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Украина · 1 центр

• National Medical University Bogomolets — Kyiv

Идентификаторы

NCT: NCT07048990 · EMPOWER_UA_ADULTS_2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗