Evaluating the Effects of a Self-help Mobile Phone Application on Worry and Overthinking in Young Adults Aged Between 16 and 24.

Study Overview
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Brief Summary
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This project seeks to understand if a new self-help mobile phone application (called MyMoodCoach) is effective at reducing worry and overthinking, prominent risk factors that predict reduced well-being and poor mental health. As a primary outcome, the investigators are predicting that people who use the app will report more significant reductions on measures of overthinking than those who do not. The investigators also predict that people who use the app will report more significant reductions in measures of worry as well as reported symptoms of depression and anxiety. Further, it is predicted that people who use the app will report a significantly higher increase in their well-being compared to those who do not.

Detailed Description
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The Emotional Competence for Well-Being in Young Adults study has developed an emotional competence app to be examined via cohort multiple randomised controlled trial (cmRCT) in a longitudinal prospective cohort. This off-shoot study adapts the app to focus on targeting worry and overthinking (also known as rumination), which are prominent risk factors for poor mental health. Within this study, 16-24-year-olds in the UK, who report elevated worry and rumination on standardised questionnaires are randomised to either receive the mobile phone app immediately or to receive the app after a wait of 6 weeks. In total, the study will aim to recruit 204 participants across the UK. Assessments take place at baseline (pre-randomisation), 6 and 12 weeks post-randomisation. Primary endpoint for the study is the change in levels of rumination assessed at 6 weeks after randomisation. Worry, depressive symptoms, anxiety symptoms and well-being are secondary outcomes. Compliance, adverse events, and potentially mediating variables will be carefully monitored. This trial aims to provide a better understanding of the benefits of tackling rumination and worry via an intervention delivered via mobile phone app with respect to promoting well-being and preventing poor mental health in young people. This prevention mechanism trial will establish whether targeting worry and rumination directly via an app provides a feasible approach to prevent depression and anxiety, with scope to become a widescale public health strategy for preventing poor mental health and promoting well-being in young people.

Official Title
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Evaluating the Effects of a Self-help Mobile Phone Application on Worry and Rumination Experienced by Young Adults: a Preventative Intervention for Depression and Anxiety

Conditions
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Rumination, Worry, Repetitive Negative Thinking

Intervention / Treatment
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* Device: digital CBT self-help including specific intervention elements to target worry and rumination.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: aged 16 to 24 years old (inclusive) currently based in the UK possess a basic literacy in English able to provide informed consent reporting elevated levels of worry and rumination, defined here as scoring above the 50th percentile (i.e., top-half of scale) on either the RSS (>34) or the PSWQ (>41) have regular access to a smartphone (android or iOS). Exclusion Criteria: reporting highly elevated symptoms of depression indicating more specialist treatment is required (PHQ-9 > 20) self-report of active suicidality self-report currently receiving psychological therapy, counseling, or psychiatric medication, including antidepressants, for a current mental health condition

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 24 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The trial design is of a superiority two-arm parallel-group single-blind randomised controlled trial comparing usual practice plus up to 6 weeks of using the repetitive negative thinking-targeting digital self-help app versus usual practice and waiting list control. The primary hypothesis is that the rumination-targeting digital self-help app will reduce rumination and worry significantly more than waiting list control at 6 weeks follow-up.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: waiting list control group<br>Participants randomly allocated to this arm will be offered self-help components within a mobile phone app to target worry and rumination after a 6-week wait. | Device: digital CBT self-help including specific intervention elements to target worry and rumination.<br>* The self-help app includes self-monitoring, psychoeducation and active self-help exercises. The self-monitoring includes daily mood ratings and an ecological momentary assessment option (MoodTracker) for more detailed analysis of mood, worry, activity and situational context. The digital self-help provides psychoeducation, tips, advice, exercises and training for each individual focused on reducing worry and rumination, using strategies from the proven rumination-focused CBT intervention. The app includes text, pictures, audio-recordings, animations, audio-exercises to practice (e.g., self-compassion, relaxation, concreteness exercises), and questionnaires with tailored feedback. The app is designed for iOS and Android use.<br>* Other names: MyMoodCoach;|
| Experimental: treatment group<br>Participants randomly allocated to this arm will be offered self-help components within a mobile phone app to target worry and rumination immediately. | Device: digital CBT self-help including specific intervention elements to target worry and rumination.<br>* The self-help app includes self-monitoring, psychoeducation and active self-help exercises. The self-monitoring includes daily mood ratings and an ecological momentary assessment option (MoodTracker) for more detailed analysis of mood, worry, activity and situational context. The digital self-help provides psychoeducation, tips, advice, exercises and training for each individual focused on reducing worry and rumination, using strategies from the proven rumination-focused CBT intervention. The app includes text, pictures, audio-recordings, animations, audio-exercises to practice (e.g., self-compassion, relaxation, concreteness exercises), and questionnaires with tailored feedback. The app is designed for iOS and Android use.<br>* Other names: MyMoodCoach;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in rumination using the Ruminative Response Scale (RRS) | A well established 22-item measure of pathological rumination which predicts subsequent depression. | Change from baseline at 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in worry using the Penn State Worry Questionnaire (PSWQ) | a well-validated 16-item measure of trait tendency towards worry | Change from baseline at 6 weeks | 
| Change in symptoms for depression using the Patient Health Questionnaire-9 (PHQ-9) | a well-validated measure of depression and depressive symptoms | Change from baseline at 6 weeks | 
| Change in wellbeing using the Warwick-Edinburgh Mental Well Being Scale (WEMWBS) | a leading validated self-reported index of well-being with excellent psychometric properties comprising 14 items | Change from baseline at 6 weeks | 
| Change in symptoms for anxiety using the Generalized Anxiety Disorder-7 (GAD-7) | A well validated measure of anxiety and anxiety symptoms | Change from baseline at 6 weeks |