Not Yet RecruitingNot Applicable

Solomiya App - CBT-based Self-help Intervention

Ukraine80 participantsStarted 2026-04-15

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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) Exclusion Criteria: * 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)

What they're measuring

Feasibility of Solomiya app

Timeframe: Post-intervention (4 weeks from baseline)

Acceptability of Solomiya app

Timeframe: Post-intervention (4 weeks from baseline)

Trial details

NCT IDNCT07104695

SponsorSolveig Kemna

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06-30

Contact for this trial

Solveig Kemna, MD

+49 30 450 517 542 solveig.kemna@charite.de