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

NCT04950257 | Completed

• 1 other identifier: eCLESPsy001977
• Study Type: interventional
• Target: 236
• Locations: 1 country
• Sites: 1

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.

Conditions

Rumination; Worry; Repetitive Negative Thinking

Outcome Measures

Primary Outcomes (1)

• Change in rumination using the Ruminative Response Scale (RRS)

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

  Change from baseline at 6 weeks

Secondary Outcomes (4)

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

  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

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

  Change from baseline at 6 weeks

Other Outcomes (5)

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

  Change from 6 weeks post randomisation at 12 weeks post randomisation

• Change in rumination using the Ruminative Response Scale (RRS)

  Change from 6 weeks post randomisation at 12 weeks post randomisation

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

  Change from 6 weeks post randomisation at 12 weeks post randomisation

Study Arms (2)

waiting list control group

ACTIVE COMPARATOR

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.

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

treatment group

EXPERIMENTAL

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

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

Interventions

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.

Also known as: MyMoodCoach

treatment group; waiting list control group

Eligibility Criteria

• Age: 16 Years - 24 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Exeter: lead

Study Sites (1)

University of Exeter

Exeter, Devon, EX2 5DY, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 34674669 BACKGROUND

• Edge D, Watkins E, Newbold A, Ehring T, Frost M, Rosenkranz T. Evaluating the Effects of a Self-Help Mobile Phone App on Worry and Rumination Experienced by Young Adults: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2024 Aug 13;12:e51932. doi: 10.2196/51932.

  PMID: 39137411 DERIVED

MeSH Terms

Conditions

Rumination Syndrome

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Feeding and Eating Disorders; Mental Disorders

Study Officials

• Ed R Watkins, Professor

  Exeter University

  STUDY DIRECTOR

• Dan J Edge, MRes

  Exeter University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The analysis team members will be blind to the randomisation process and group allocation of participants
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Trainee Clinical Psychologist

Model Details: 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.

Study Record Dates

• First Submitted: June 22, 2021
• First Posted: July 6, 2021
• Study Start: May 14, 2021
• Primary Completion: December 13, 2021
• Study Completion: January 30, 2022
• Last Updated: February 1, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The study protocol and informed consent form will be uploaded with this registration. The SAP is included in the study protocol. Data Access: Post-analysis, the final anonymised dataset will preferentially be stored in Open Research Exeter (ORE), the University of Exeter's open access repository. The data will be available from 24 months after trial completion (end of December 2021).
• Access Criteria: Access to these data is permitted but controlled through requests made via the repository to a review panel from the trial team, led by the chief investigator, which will assess requests on scientific merit and commercial sensitivity. Although use is permitted, this will be on the basis that the source of the data is acknowledged (including the funder) and it includes reference to the data set 'handle', and a data access agreement is signed, subject to approval by funder.

Locations

GB (1)