Clinical trial NCT04950257: Evaluating the Effects of a Self-help Mobile Phone Application on Worry and Overthinking in Young Adults Aged Between 16 and 24.
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rumination
Worry
Repetitive Negative Thinking
Lead sponsor: University of Exeter
Sponsor class: OTHER
First posted: 2021-07-06
Enrollment: 236
Sex: ALL
Minimum age (years): 16
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Change in rumination using the Ruminative Response Scale (RRS)
timeFrame: Change from baseline at 6 weeks
Secondary outcomes:
measure: Change in worry using the Penn State Worry Questionnaire (PSWQ)
timeFrame: Change from baseline at 6 weeks
measure: Change in symptoms for depression using the Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Change from baseline at 6 weeks
measure: Change in wellbeing using the Warwick-Edinburgh Mental Well Being Scale (WEMWBS)
timeFrame: Change from baseline at 6 weeks
measure: Change in symptoms for anxiety using the Generalized Anxiety Disorder-7 (GAD-7)
timeFrame: Change from baseline at 6 weeks
Other outcomes:
measure: Change in worry using the Penn State Worry Questionnaire (PSWQ)
timeFrame: Change from 6 weeks post randomisation at 12 weeks post randomisation
measure: Change in rumination using the Ruminative Response Scale (RRS)
timeFrame: Change from 6 weeks post randomisation at 12 weeks post randomisation
measure: Change in symptoms for depression using the Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Change from 6 weeks post randomisation at 12 weeks post randomisation
measure: Change in wellbeing using the Warwick-Edinburgh Mental Well Being Scale (WEMWBS)
timeFrame: Change from 6 weeks post randomisation at 12 weeks post randomisation
measure: Change in symptoms for anxiety using the Generalized Anxiety Disorder-7 (GAD-7)
timeFrame: Change from 6 weeks post randomisation at 12 weeks post randomisation
Locations:
city: Exeter
country: United Kingdom
facility: University of Exeter
state: Devon
Study officials:
affiliation: Exeter University
name: Ed R Watkins, Professor
role: STUDY_DIRECTOR
affiliation: Exeter University
name: Dan J Edge, MRes
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.