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NOT YET RECRUITING
NCT07104695
NA

Solomiya App - CBT-based Self-help Intervention

Sponsor: Solveig Kemna

View on ClinicalTrials.gov

Summary

The project aims to investigate the feasibility and acceptability of a smartphone intervention for depressive symptoms and insomnia in people living under prolonged stress due to the ongoing war in Ukraine. A secondary aim is to assess the clinical outcomes of the intervention by comparing changes in symptoms from baseline (T0) to post-intervention (T1 \&T2) (single-arm feasibility design). The participants will receive an app-based smartphone intervention with psychoeducational content, relaxation exercises and mindfulness-based interventions and symptom tracking.

Official title: Studying the Feasibility and Acceptability of the SOLOMIYA App - a Smartphone-Based Intervention for People Living Under Prolonged Stress Due to the Ongoing War in Ukraine

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2026-04-15

Completion Date

2026-06-30

Last Updated

2026-04-07

Healthy Volunteers

No

Interventions

BEHAVIORAL

Solomiya App - CBT-based self-help intervention

Solomiya App - CBT-based self-help intervention The Solomiya app is a mobile-based self-help intervention designed to reduce and cope with depressive symptoms and improve sleep in individuals exposed to chronic stress. It has been created within the Solomiya project and is based on preliminary work in other international health settings (Böge 2022) where it has shown to improve depressive symptoms as part of a Stepped Care and Collaborative Model (SCCM). It includes psychoeducational multimedia modules on stress management and sleep problems, along with cognitive behavioral therapy (CBT)-based tools such as guided relaxation exercises, mindfulness practices, and behavioral activation strategies. The app also offers symptom tracking using the PHQ-9 to support user self-monitoring. Participants are instructed to engage with the app regularly over a 4 week period. The intervention is entirely self-guided and does not involve therapist support. App usage and adherence data will be collect

Locations (1)

Bogomolets National Medical University

Kyiv, Kyiv Oblast, Ukraine