Clinical Trial

Solomiya App - CBT-based Self-help Intervention

Study acronym: SOLOAPP-FAIT
Not Yet Recruiting
View on ClinicalTrials.gov →
Record status
This record was last updated April 7, 2026 (before its estimated June 30, 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-07-29; most recent amendment 2026-04-01.
Trial Details
NCT Number NCT07104695
Lead Sponsor Solveig Kemna
Collaborators: Bogomolets National Medical University
Conditions Stress - Prevention of Sleep Disorders, PTSD and Depression
Enrollment 80 participants
Start Date 2026-04-15
Primary Completion 2026-06-30 (estimated)
Study Completion 2026-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-04-07