Solomiya App - CBT-based Self-help Intervention
Starting soon · Not applicable
Conditions studied: Stress - Prevention of Sleep Disorders, PTSD and Depression
In brief
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.
Key facts
- Study ID
- NCT07104695
- Run by
- Solveig Kemna
- People needed
- 80
- Starts
- 2026-04-15
- Expected to finish
- 2026-06-30
- Last updated by the study team
- 2026-04-07
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Civilians
- Be in possession of a smartphone
- Be minimum 18 years of age
- Sufficient knowledge of Ukrainian or Russian
- Mild or moderate depression or distress (PHQ-9 score 5-14) OR mild or moderate insomnia symptoms (ISI score 8-21)
You may not qualify if…
- Acute suicidal tendencies (defined as a score of 1 or greater on item 9 of the PHQ-9)
- Moderately severe depression (defined as a PHQ-9 score of 15 or more)
- Severe insomnia (defined as a ISI score of 22 or more)
- Neither displaying symptoms of mild or moderate depression NOR mild or moderate insomnia symptoms (defined as both scores to be below the mild classification: a PHQ-9 score 4 or less AND a ISI score 7 or less)
Where it is running
- Bogomolets National Medical University — Kyiv, Kyiv Oblast, Ukraine
Full record on ClinicalTrials.gov
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