Feasibility of Empowerment Group Therapy on Ukrainian Adult Outpatients

Charite University, Berlin, Germany55 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Interventions

Empowerment Group TherapyBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Outcomes

Primary Outcomes

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)

Secondary Outcomes

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.