The Effects of Empowerment Group Therapy on Ukrainian Adult Outpatients Located Inside the Country During the War
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Feasibility of the intervention
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Feasibility of the intervention
时间窗: 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.
Acceptability of the intervention
时间窗: 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).
次要结局
- Resilience(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))
- Stress, anxiety and depression(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(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(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(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(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))
研究者
Solveig Kemna
Resident/research associate
Charite University, Berlin, Germany