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| Name | Class |
|---|---|
| Bogomolets National Medical University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Solomiya App - CBT-based self-help intervention | Experimental | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Solomiya App - CBT-based self-help intervention | Behavioral | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of Solomiya app | Feasibility will be assessed using predefined progression criteria concerning
| 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Solveig Kemna, MD | Contact | +49 30 450 517 542 | solveig.kemna@charite.de |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bogomolets National Medical University | Kyiv | Kyiv Oblast | Ukraine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18696313 | Background | 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. | |
| 35694653 | Background | 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. |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| D003863 | Depression |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
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| 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) |
| 28213598 | Background | 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. |
| D001519 | Behavior |