Stress - Prevention of Sleep Disorders, PTSD and Depression
Conditions
Keywords
Mobile intervention, Chronic stress, Feasibility
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 &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
BEHAVIORALSolomiya 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
Sponsors
Solveig Kemna
Bogomolets National Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Depressive Symptoms | At baseline and post-intervention (4 and 8 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 and 8 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 and 8 weeks from baseline) | 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. |
| Psychological Distress (Depression, Anxiety, Stress) | At baseline and post-intervention (4 and 8 weeks from baseline) | 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. |
| Health-Related Quality of Life | At baseline and post-intervention (4 and 8 weeks from baseline) | 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. |
Countries
Ukraine
Contacts
CONTACTSolveig Kemna, MD
Outcome results
None listed