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Helping people manage anxiety and depression using mindfulness and emotional awareness through smartphone-based support

Mindfulness and mentalization smartphone-based Ecological Momentary Interventions for common mental health problems: a pilot randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN13546434
Enrollment
80
Registered
2025-09-29
Start date
2024-03-03
Completion date
Unknown
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression, anxiety Mental and Behavioural Disorders

Interventions

All participants download the m-path app. They then complete identical ecological momentary assessments (EMA) four times daily for 28 days, scheduled around individual sleep-wake times. Each assessmen

Sponsors

University College London
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 120 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 years or above 2. Currently experiencing symptoms of anxiety and/or depression (scoring in clinical range, a ‘caseness’ threshold score of >9 on the PHQ-9, or >7 on the GAD-7) 3. Able to access and use a personal smartphone 4. Had daily contact with a partner, family member(s) or friend 5. Were able to read and write in English 6. Were registered with a GP in the UK.

Exclusion criteria

Exclusion criteria: 1. Currently receiving psychological therapy 2. Taking medication for their mental health 3. Expressing any suicidal ideation or thoughts of self-harm at the point of screening (i.e. scored >0 on question nine of the PHQ-9)

Design outcomes

Primary

MeasureTime frame
1. Recruitment rate evaluated by tracking the number of individuals screened, the number meeting eligibility criteria, and the percentage of eligible participants who subsequently consented and were randomised to a study arm. 2. Retention rates defined as the percentage of randomised participants who completed the final study assessment at 4-week. 3. Adherence rates operationalised as the percentage of participants who engaged with at least 60% of the EMAs over the 4-week intervention period. 4. Engagement with the intervention content measured by the average number of mindfulness or mentalizing exercises completed per participant throughout the intervention period, as recorded by the application. 5. Acceptability post intervention measures using a post-intervention questionnaire. This assessment aims to understand participants' perceptions of the intervention's usability, utility, and overall experience. In addition to quantitative ratings, participants provide open-ended questions to offer qualitative feedback on their overall experience, including perceived benefits, challenges, suggestions for improvement, and any other relevant comments regarding the intervention and the delivery method.

Secondary

MeasureTime frame
At baseline and post intervention (4 weeks): 1. Depression (PHQ-9) 2. Anxiety (GAD-7)

Countries

England, United Kingdom

Contacts

Public ContactCiarán O'Driscoll
c.odriscoll@ucl.ac.uk+44 (0) 20 7679 2000

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 4, 2026