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Completed

NCT Number: NCT04950257

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

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.

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Key information

Conditions

Rumination Digestive System Diseases Feeding and Eating Disorders Gastrointestinal Diseases Mental Disorders Repetitive Negative Thinking Rumination Syndrome Worry

Age range

16 year–24 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Exeter

Exeter, Devon, EX2 5DY, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

digital CBT self-help including specific intervention elements to target worry and rumination.

Device

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.

Other names: MyMoodCoach

Primary outcomes

  1. 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

  1. Change in worry using the Penn State Worry Questionnaire (PSWQ)

    Time frame: Change from baseline at 6 weeks

    a well-validated 16-item measure of trait tendency towards worry

  2. Change in symptoms for depression using the Patient Health Questionnaire-9 (PHQ-9)

    Time frame: Change from baseline at 6 weeks

    a well-validated measure of depression and depressive symptoms

  3. Change in wellbeing using the Warwick-Edinburgh Mental Well Being Scale (WEMWBS)

    Time frame: Change from baseline at 6 weeks

    a leading validated self-reported index of well-being with excellent psychometric properties comprising 14 items

  4. Change in symptoms for anxiety using the Generalized Anxiety Disorder-7 (GAD-7)

    Time frame: Change from baseline at 6 weeks

    A well validated measure of anxiety and anxiety symptoms

Other outcomes

  1. Change in worry using the Penn State Worry Questionnaire (PSWQ)

    Time frame: Change from 6 weeks post randomisation at 12 weeks post randomisation

    a well-validated 16-item measure of trait tendency towards worry

  2. Change in rumination using the Ruminative Response Scale (RRS)

    Time frame: Change from 6 weeks post randomisation at 12 weeks post randomisation

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

  3. Change in symptoms for depression using the Patient Health Questionnaire-9 (PHQ-9)

    Time frame: Change from 6 weeks post randomisation at 12 weeks post randomisation

    a well-validated measure of depression and depressive symptoms

  4. Change in wellbeing using the Warwick-Edinburgh Mental Well Being Scale (WEMWBS)

    Time frame: 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

  5. Change in symptoms for anxiety using the Generalized Anxiety Disorder-7 (GAD-7)

    Time frame: Change from 6 weeks post randomisation at 12 weeks post randomisation

    A well validated measure of anxiety and anxiety symptoms

Sponsors and collaborators

Lead sponsor

University of Exeter

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Jul 6, 2021
Registry last updated
Feb 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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