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Clinical Trials/NCT04950257
NCT04950257
Completed
Not Applicable

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

University of Exeter1 site in 1 country236 target enrollmentMay 14, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Rumination
Sponsor
University of Exeter
Enrollment
236
Locations
1
Primary Endpoint
Change in rumination using the Ruminative Response Scale (RRS)
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 14, 2021
End Date
January 30, 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Daniel Edge

Trainee Clinical Psychologist

University of Exeter

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change in rumination using the Ruminative Response Scale (RRS)

Time Frame: Change from baseline at 6 weeks

A well established 22-item measure of pathological rumination which predicts subsequent depression.

Secondary Outcomes

  • Change in worry using the Penn State Worry Questionnaire (PSWQ)(Change from baseline at 6 weeks)
  • Change in symptoms for anxiety using the Generalized Anxiety Disorder-7 (GAD-7)(Change from baseline at 6 weeks)
  • Change in symptoms for depression using the Patient Health Questionnaire-9 (PHQ-9)(Change from baseline at 6 weeks)
  • Change in wellbeing using the Warwick-Edinburgh Mental Well Being Scale (WEMWBS)(Change from baseline at 6 weeks)

Study Sites (1)

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