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

University of Exeter

Status: Completed

Conditions: Worry; Repetitive Negative Thinking; Rumination

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04950257

eCLESPsy001977

Details and patient eligibility

About

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.

Full 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.

Enrollment: 236 patients

Sex: All

Ages: 16 to 24 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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236 participants in 2 patient groups

waiting list control group

Active Comparator group

Description:

Participants randomly allocated to this arm will be offered self-help components within a mobile phone app to target worry and rumination after a 6-week wait.

Treatment:

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

treatment group

Experimental group

Description:

Participants randomly allocated to this arm will be offered self-help components within a mobile phone app to target worry and rumination immediately.

Treatment:

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