Evaluating the Effects of a Self-help Mobile Phone Application on Worry and Overthinking in Young Adults Aged Between 16 and 24.
Condition: Rumination; Worry; Repetitive Negative Thinking
MeSH terms: Rumination Syndrome
Study type: Interventional

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.
    

Intervention name(s): digital CBT self-help including specific intervention elements to target worry and rumination.
Intervention type(s): Device
Intervention description(s): 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 intervention name(s): MyMoodCoach
Allocation: Randomized
Intervention model: Parallel Assignment
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.
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention