Solomiya App - CBT-based Self-help Intervention

Not Applicable

Not yet recruiting

• Conditions: Stress - Prevention of Sleep Disorders, PTSD and Depression

• Registration Number: NCT07104695
• Lead Sponsor: Solveig Kemna

Brief 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) (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.

Detailed Description

Participants will be recruited via Educational - scientific institute of mental health of the Bogomolets National Medical University. An online eligibility screening will be conducted prior to study inclusion via a secure form.

The SOLOMIYA app has been created within the Solomiya project (available on iOS (App Store) and Android (Google Play) platforms) and is based on preliminary work in other international health settings (Böge 2022). It combines psychoeducational multimedia content (e.g., on stress management and sleep problems) and evidence-based CBT-based therapy tools such as relaxation and mindfulness techniques. The app enables users to self-monitor stress symptoms using the PHQ-9 scale.

Participants will carry out self-reported assessments at baseline (T0) and after the intervention phase of 4-6 weeks (T1). App feasibility and acceptability will be evaluated via user behaviour, particularly in terms of adoption, retention and dropout.

User behaviour data will be collected via aggregated app usage metrics as well as user-approved in-app tracking of individual usage patterns, including session frequency and engagement with specific features. Mental health parameters such as depressive symptoms, psychological distress, and sleep quality will be assessed using standardised, validated questionnaires administered at T0 and T1.

The data management plan includes standard procedures for data-handling such as using anonymized identification codes for patient data. The data will be collected and saved in a GDPR-compliant online database (REDCap) on German servers, only allowing researchers involved in the study to access the data.

Study Timeline

• Study First Submitted: 2025-07-29
• Study First Submitted QC: 2025-07-29
• Status Verified: 2025-08
• Study First Posted: 2025-08-05
• Last Update Submitted: 2025-08-05
• Last Update Posted: 2025-08-08
• Study Start: 2025-10-01
• Primary Completion: 2026-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Feasibility of Solomiya app	Post-intervention (4 weeks from baseline)	Feasibility will be assessed using predefined progression criteria concerning; * Adoption (initial uptake/ download rates/ completion of onboarding); * Retention rates measured by completion of the app modules; * Rate of participants considered as having dropped out Feasibility will be assessed using predefined progression criteria based on recruitment, engagement, retention, and safety, which are detailed below. The criteria will be operationalized with an approach using traffic-light benchmarks (Avery 2017).
Acceptability of Solomiya app	Post-intervention (4 weeks from baseline)	Acceptability will be assessed by using the Client Satisfaction Questionnaire (Attkisson \& Zwick, 1982) and a series of open-ended questions about app usability, relevance and acceptability. No serious adverse events related to app use are expected.

Secondary Outcome Measures

Name	Time	Method
Depressive Symptoms	At baseline and post-intervention (4 weeks from baseline)	Patient Health Questionnaire - 9 (Kroenke, 2001). The Patient Health Questionnaire-9 (PHQ-9) is a 9-item scale assessing depressive symptoms (Kroenke et al., 2001). Scores range from 0 to 27, with higher scores indicating worse outcomes (i.e., more severe depression).
Sleep quality	At baseline and post-intervention (4 weeks from baseline)	Insomnia Severity Index (ISI) (Bastien 2001). The Insomnia Severity Index (ISI) is a 7-item scale measuring the nature, severity, and impact of insomnia (Bastien et al., 2001). Scores range from 0 to 28, with higher scores indicating worse outcomes, i.e., more severe insomnia.
Resilience	At baseline and post-intervention (4 weeks from baseline). The Brief Resilience Scale (BRS) is a 6-item scale designed to assess the ability to recover from stress (Smith et al., 2009). Scores range from 1 to 5, averaged across items, with higher scores	Brief Resilience Scale (Smith 2009)

Trial Locations

Locations (1)

Bogomolets National Medical University; 🇺🇦 Kyiv, Ukraine