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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04950257
Other study ID # eCLESPsy001977
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 14, 2021
Est. completion date January 30, 2022

Study information

Verified date January 2022
Source University of Exeter
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 236
Est. completion date January 30, 2022
Est. primary completion date December 13, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 16 Years to 24 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
digital 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.

Locations

Country Name City State
United Kingdom University of Exeter Exeter Devon

Sponsors (1)

Lead Sponsor Collaborator
University of Exeter

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

Edge D, Newbold A, Ehring T, Rosenkranz T, Frost M, Watkins ER. Reducing worry and rumination in young adults via a mobile phone app: study protocol of the ECoWeB (Emotional Competence for Well-Being in Young Adults) randomised controlled trial focused on repetitive negative thinking. BMC Psychiatry. 2021 Oct 21;21(1):519. doi: 10.1186/s12888-021-03536-0. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Change in worry using the Penn State Worry Questionnaire (PSWQ) a well-validated 16-item measure of trait tendency towards worry Change from 6 weeks post randomisation at 12 weeks post randomisation
Other Change in rumination using the Ruminative Response Scale (RRS) A well established 22-item measure of pathological rumination which predicts subsequent depression. Change from 6 weeks post randomisation at 12 weeks post randomisation
Other Change in symptoms for depression using the Patient Health Questionnaire-9 (PHQ-9) a well-validated measure of depression and depressive symptoms Change from 6 weeks post randomisation at 12 weeks post randomisation
Other 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 6 weeks post randomisation at 12 weeks post randomisation
Other Change in symptoms for anxiety using the Generalized Anxiety Disorder-7 (GAD-7) A well validated measure of anxiety and anxiety symptoms Change from 6 weeks post randomisation at 12 weeks post randomisation
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
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