RuminationNCT04950257
Evaluating the Effects of a Self-help Mobile Phone Application on Worry and Overthinking in Young Adults Aged Between 16 and 24.
A study testing digital CBT self-help including specific intervention elements to target worry and rumination. in people with Rumination and Worry, run by University of Exeter at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Rumination, Worry, Repetitive Negative Thinking
- What is being tested?
- digital CBT self-help including specific intervention elements to target worry and rumination.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 236 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 May 2021to 30 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 24 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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).
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Rumination, Worry, Repetitive Negative Thinking
- Being tested
- digital CBT self-help including specific intervention elements to target worry and rumination.
- Medical subject headings
- Rumination Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
digital CBT self-help including specific intervention elements to target worry and rumination.Device
Also called MyMoodCoach
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: digital CBT self-help including specific intervention elements to target worry and rumination. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in rumination using the Ruminative Response Scale (RRS)
A well established 22-item measure of pathological rumination which predicts subsequent depression.
Measured: Change from baseline at 6 weeks
Secondary outcomes (4)
Change in worry using the Penn State Worry Questionnaire (PSWQ)
a well-validated 16-item measure of trait tendency towards worry
Measured: Change from baseline at 6 weeks
Change in symptoms for depression using the Patient Health Questionnaire-9 (PHQ-9)
a well-validated measure of depression and depressive symptoms
Measured: Change from baseline at 6 weeks
Change in wellbeing using the Warwick-Edinburgh Mental Well Being Scale (WEMWBS)
a leading validated self-reported index of well-being with excellent psychometric properties comprising 14 items
Measured: Change from baseline at 6 weeks
Change in symptoms for anxiety using the Generalized Anxiety Disorder-7 (GAD-7)
A well validated measure of anxiety and anxiety symptoms
Measured: Change from baseline at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2021
- Study start14 May 2021
- Primary completion13 Dec 2021
- Study completion30 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for RuminationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 236 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Exeter
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Edge, University of Exeter
- Investigators
- Ed R Watkins, Professor, Study director, Exeter UniversityDan J Edge, MRes, Principal investigator, Exeter University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04950257
- Sponsor's protocol ID
- eCLESPsy001977
- Status last verified
- Jan 2022
- First submitted
- 22 Jun 2021
- Last updated
- 1 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant and clinical and economic data reported in publications will be made available through the University of Exeter's Institutional Repository - Open Research Exeter (see https://ore.exeter.ac.uk).
Publications
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.
PubMed 34674669Edge 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.
PubMed 39137411
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04950257
- Acronym / sponsor ID
- eCLESPsy001977
- Conditions
- Rumination, Worry, Repetitive Negative Thinking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 236 participants (actual)
- Lead sponsor
- University of ExeterUniversity, hospital or other
- Study start
- 14 May 2021 (actual)
- Primary completion
- 13 Dec 2021 (actual)
- Study completion
- 30 Jan 2022 (actual)
- First posted
- 6 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| waiting list control group | Active comparator | Device: digital CBT self-help including specific intervention elements to target worry and rumination.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 group | Experimental | Device: digital CBT self-help including specific intervention elements to target worry and rumination.Participants randomly allocated to this arm will be offered self-help components within a mobile phone app to target worry and rumination immediately. |
Who may qualify
- Ages
- 16 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| digital CBT self-help including specific intervention elements to target worry and rumination.Also: MyMoodCoachThe 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. | Device | treatment group, waiting list control group |
Primary outcome
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.
4 secondary outcomes
Change in worry using the Penn State Worry Questionnaire (PSWQ)
Time frame: Change from baseline at 6 weeks
Change in symptoms for depression using the Patient Health Questionnaire-9 (PHQ-9)
Time frame: Change from baseline at 6 weeks
Change in wellbeing using the Warwick-Edinburgh Mental Well Being Scale (WEMWBS)
Time frame: Change from baseline at 6 weeks
Change in symptoms for anxiety using the Generalized Anxiety Disorder-7 (GAD-7)
Time frame: Change from baseline at 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2022.
- Background: PubMed 34674669Edge 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.
- Derived from this study: PubMed 39137411Edge 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.
- Individual participant dataSharing planned: Yes. De-identified individual participant and clinical and economic data reported in publications will be made available through the University of Exeter's Institutional Repository - Open Research Exeter (see https://ore.exeter.ac.uk).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ed R Watkins, Professor study director
Exeter University
Dan J Edge, MRes principal investigator
Exeter University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing digital CBT self-help including specific intervention elements to target worry and rumination. in people with Rumination and Worry, run by University of Exeter at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in rumination using the Ruminative Response Scale (RRS) (time frame: Change from baseline at 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04950257, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2022.