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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Acceptability of Solomiya app
研究概览
简要总结
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) (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.
详细描述
Participants will be recruited via Educational - scientific institute of mental health of the Bogomolets National Medical University. An online eligibility screening will be conducted prior to study inclusion via a secure form.
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 4-6 weeks (T1). 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, and sleep quality will be assessed using standardised, validated questionnaires administered at T0 and T1.
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 (REDCap) on German servers, only allowing researchers involved in the study to access the data.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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)
研究组 & 干预措施
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
干预措施: Solomiya App - CBT-based self-help intervention (Behavioral)
结局指标
主要结局
Acceptability of Solomiya app
时间窗: 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.
Feasibility of Solomiya app
时间窗: 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).
次要结局
- Depressive Symptoms(At baseline and post-intervention (4 weeks from baseline))
- Depressive Symptoms(At baseline and post-intervention (4 weeks from baseline))
- Sleep quality(At baseline and post-intervention (4 weeks from baseline))
- Resilience(At baseline and post-intervention (4 weeks from baseline). 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)
研究者
Solveig Kemna
Dr. med.
Charite University, Berlin, Germany