Solomiya App - CBT-based Self-help Intervention

Official title

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

Overview

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.

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.

Interventions

• 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

Primary outcome measures

• Feasibility of Solomiya app [Time frame: Post-intervention (4 weeks from baseline)]
• Acceptability of Solomiya app [Time frame: Post-intervention (4 weeks from baseline)]

Secondary outcome measures (5)

• Depressive Symptoms [Time frame: At baseline and post-intervention (4 and 8 weeks from baseline)]
• Sleep quality [Time frame: At baseline and post-intervention (4 and 8 weeks from baseline)]
• Resilience [Time frame: At baseline and post-intervention (4 and 8 weeks from baseline)]
• Psychological Distress (Depression, Anxiety, Stress) [Time frame: At baseline and post-intervention (4 and 8 weeks from baseline)]
• Health-Related Quality of Life [Time frame: At baseline and post-intervention (4 and 8 weeks from baseline)]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Prevention

Study locations

Ukraine · 1 center

• Bogomolets National Medical University — Kyiv

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. PMID 18696313
• 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 depres PMID 35694653
• 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/b PMID 28213598

Identifiers

NCT: NCT07104695 · SOL2025UA-DIGIINTV-001

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗