Repetitive Negative Thinking, Rumination, Worry
Conditions
Brief summary
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
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.
Interventions
DEVICEdigital CBT self-help including specific intervention elements to target worry and rumination.
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.
Sponsors
University of Exeter
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
The analysis team members will be blind to the randomisation process and group allocation of participants
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
16 Years to 24 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in rumination using the Ruminative Response Scale (RRS) | Change from baseline at 6 weeks | A well established 22-item measure of pathological rumination which predicts subsequent depression. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in worry using the Penn State Worry Questionnaire (PSWQ) | Change from baseline at 6 weeks | a well-validated 16-item measure of trait tendency towards worry |
| Change in symptoms for depression using the Patient Health Questionnaire-9 (PHQ-9) | Change from baseline at 6 weeks | a well-validated measure of depression and depressive symptoms |
| Change in wellbeing using the Warwick-Edinburgh Mental Well Being Scale (WEMWBS) | Change from baseline at 6 weeks | a leading validated self-reported index of well-being with excellent psychometric properties comprising 14 items |
| Change in symptoms for anxiety using the Generalized Anxiety Disorder-7 (GAD-7) | Change from baseline at 6 weeks | A well validated measure of anxiety and anxiety symptoms |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in worry using the Penn State Worry Questionnaire (PSWQ) | Change from 6 weeks post randomisation at 12 weeks post randomisation | a well-validated 16-item measure of trait tendency towards worry |
| Change in rumination using the Ruminative Response Scale (RRS) | Change from 6 weeks post randomisation at 12 weeks post randomisation | A well established 22-item measure of pathological rumination which predicts subsequent depression. |
| Change in symptoms for depression using the Patient Health Questionnaire-9 (PHQ-9) | Change from 6 weeks post randomisation at 12 weeks post randomisation | a well-validated measure of depression and depressive symptoms |
| Change in wellbeing using the Warwick-Edinburgh Mental Well Being Scale (WEMWBS) | Change from 6 weeks post randomisation at 12 weeks post randomisation | a leading validated self-reported index of well-being with excellent psychometric properties comprising 14 items |
| Change in symptoms for anxiety using the Generalized Anxiety Disorder-7 (GAD-7) | Change from 6 weeks post randomisation at 12 weeks post randomisation | A well validated measure of anxiety and anxiety symptoms |
Countries
United Kingdom
Outcome results
None listed