Solomiya App - CBT-based Self-help Intervention (SOLOAPP-FAIT)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Stress - Prevention of Sleep Disorders, PTSD and Depression
• Intervention / Treatment: Behavioral: Solomiya App - CBT-based self-help intervention

Detailed Description

Participants will be recruited via Educational - scientific institute of mental health of the Bogomolets National Medical University. An eligibility screening will be conducted prior to study inclusion within the Solomiya App.

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 weeks (T1) and a follow-up 4 weeks after the intervention phase (T2; 8 weeks post baseline). 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, quality of life and sleep quality will be assessed using standardised, validated questionnaires administered at T0, T1 and T2.

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 on German servers (servers that belong to the Charité), only allowing researchers involved in the study to access the data.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Solveig Kemna, MD; Phone Number: +49 30 450 517 542; Email: solveig.kemna@charite.de

Study Locations

• Ukraine
  • Kyiv Oblast
    • Kyiv, Kyiv Oblast, Ukraine
      • Bogomolets National Medical University
      • Contact: Lesia Sak, MD, PhD; Phone Number: +380936057209; Email: lesia.sak@gmail.com
      • Principal Investigator: Lesia Sak, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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 collec

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of Solomiya app	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).	Post-intervention (4 weeks from baseline)
Acceptability of Solomiya app	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.	Post-intervention (4 weeks from baseline)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depressive Symptoms	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).	At baseline and post-intervention (4 and 8 weeks from baseline)
Sleep quality	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.	At baseline and post-intervention (4 and 8 weeks from baseline)
Resilience	Brief Resilience Scale (Smith 2009) . 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 indicating higher levels of resilience.	At baseline and post-intervention (4 and 8 weeks from baseline)
Psychological Distress (Depression, Anxiety, Stress)	Depression Anxiety Stress Scales - 21 (DASS-21) (Lovibond & Lovibond, 1995). The DASS-21 is a 21-item scale assessing symptoms of depression, anxiety, and stress across three subscales. Scores are summed for each subscale. Higher scores indicate greater psychological distress.	At baseline and post-intervention (4 and 8 weeks from baseline)
Health-Related Quality of Life	Short Form Health Survey (SF-36) (Ware & Sherbourne, 1992). The SF-36 is a 36-item questionnaire measuring health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, and mental health. Scores are transformed to a 0-100 scale, with higher scores indicating better health status.	At baseline and post-intervention (4 and 8 weeks from baseline)

Collaborators and Investigators

• Sponsor: Solveig Kemna
• Collaborators: Bogomolets National Medical University

Publications and helpful links

General Publications

• Smith BW, Dalen J, Wiggins K, Tooley E, Christopher P, Bernard J. The brief resilience scale: assessing the ability to bounce back. Int J Behav Med. 2008;15(3):194-200. doi: 10.1080/10705500802222972.
• Boge K, Karnouk C, Hoell A, Tschorn M, Kamp-Becker I, Padberg F, Ubleis A, Hasan A, Falkai P, Salize HJ, Meyer-Lindenberg A, Banaschewski T, Schneider F, Habel U, Plener P, Hahn E, Wiechers M, Strupf M, Jobst A, Millenet S, Hoehne E, Sukale T, Dinauer R, Schuster M, Mehran N, Kaiser F, Brocheler S, Lieb K, Heinz A, Rapp M, Bajbouj M. Effectiveness and cost-effectiveness for the treatment of depressive symptoms in refugees and asylum seekers: A multi-centred randomized controlled trial. Lancet Reg Health Eur. 2022 Jun 6;19:100413. doi: 10.1016/j.lanepe.2022.100413. eCollection 2022 Aug.
• Avery KN, Williamson PR, Gamble C, O'Connell Francischetto E, Metcalfe C, Davidson P, Williams H, Blazeby JM; members of the Internal Pilot Trials Workshop supported by the Hubs for Trials Methodology Research. Informing efficient randomised controlled trials: exploration of challenges in developing progression criteria for internal pilot studies. BMJ Open. 2017 Feb 17;7(2):e013537. doi: 10.1136/bmjopen-2016-013537.

Study record dates

Study Major Dates

• Study Start (Estimated): April 15, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: July 29, 2025
• First Submitted That Met QC Criteria: July 29, 2025
• First Posted (Actual): August 5, 2025

Study Record Updates

• Last Update Posted (Actual): April 7, 2026
• Last Update Submitted That Met QC Criteria: April 1, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Feasibility; Chronic stress; Mobile intervention
• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms; Stress Disorders, Traumatic; Behavior; Depression; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: SOL2025UA-DIGIINTV-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No