Stress - Prevention of Sleep Disorders, PTSD and DepressionSOLOAPP-FAITNCT07104695
Solomiya App - CBT-based Self-help Intervention
A study testing Solomiya App - CBT-based self-help intervention in people with Stress - Prevention of Sleep Disorders, PTSD and Depression, run by Solveig Kemna at 1 site in Ukraine.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stress - Prevention of Sleep Disorders, PTSD and Depression
- What is being tested?
- Solomiya App - CBT-based self-help intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUkraine
- Study dates
- 15 Apr 2026to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ukraine1 site
Bogomolets National Medical University
Kyiv, Kyiv Oblast
Lesia Sak, MD, PhD, +380936057209, lesia.sak@gmail.com
Lesia Sak, PhD
About this study
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
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.
Read the 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.
- Being tested
- Solomiya App - CBT-based self-help intervention
- Keywords
- Mobile intervention, Chronic stress, Feasibility
- Medical subject headings
- Stress Disorders, Post-Traumatic, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Solomiya App - CBT-based self-help interventionBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Solomiya App - CBT-based self-help intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: Post-intervention (4 weeks from baseline)
Secondary outcomes (5)
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At baseline and post-intervention (4 and 8 weeks from baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2025
- Study start15 Apr 2026 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Stress - Prevention of Sleep Disorders, PTSD and DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Solveig Kemna
- Sponsor type
- University, hospital or other
- Collaborators
- Bogomolets National Medical University
- Responsible party
- Sponsor-investigator, Solveig Kemna, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07104695
- Sponsor's protocol ID
- SOL2025UA-DIGIINTV-001
- Acronym
- SOLOAPP-FAIT
- Status last verified
- Apr 2026
- First submitted
- 29 Jul 2025
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 18696313Boge 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.
PubMed 35694653Avery 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.
PubMed 28213598
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07104695
- Acronym / sponsor ID
- SOLOAPP-FAIT / SOL2025UA-DIGIINTV-001
- Keywords
- Mobile intervention, Chronic stress, Feasibility
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Solveig KemnaUniversity, hospital or other
- Collaborators
- Bogomolets National Medical University
- Study start
- 15 Apr 2026 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 5 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Solomiya App - CBT-based self-help intervention | Experimental | Behavioral: Solomiya App - CBT-based self-help interventionThe 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Solomiya App - CBT-based self-help interventionSolomiya 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 | Behavioural | Solomiya App - CBT-based self-help intervention |
Primary outcome
Feasibility of Solomiya app
Time frame: 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
Time frame: 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.
5 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Background: PubMed 18696313Smith 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.
- Background: PubMed 35694653Boge 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.
- Background: PubMed 28213598Avery 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.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Solomiya App - CBT-based self-help intervention in people with Stress - Prevention of Sleep Disorders, PTSD and Depression, run by Solveig Kemna at 1 site in Ukraine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Solveig Kemna, MD (+49 30 450 517 542, solveig.kemna@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Solomiya app (time frame: Post-intervention (4 weeks from baseline)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07104695, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.