Feasibility and scalability of a digital mhealth training for personalized mental health promotion (Feel.Well)

Feasibility and scalability of a digital ecological momentary mhealth intervention for mental health promotion: a population-based, two-arm, parallel-group, randomized controlled trial within cohorts (TwiC)

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN26591786

Enrollment

300

Registered

2025-02-11

Start date

2024-11-05

Completion date

Unknown

Last updated

2025-02-24

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

Conditions

Promoting mental health among individuals from the general population enrolled in a digital cohort. Mental and Behavioural Disorders

Interventions

In a 2-arm, parallel-group, randomised controlled Trial within Cohorts (TWiC), registered individuals from an online cohort (DigiHero Study

https://webszh.uk-halle.de/digihero/en/digi-hero-study/) will be randomly assigned to either the experimental condition, which includes the Feel.Well training in addition to Care-As-Usual (CAU), or to

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged between 18 and 65 years 2. Scores of <=54 on the Warwick–Edinburgh Mental Well-being Scale (WEMWBS). 3. Have access to a smartphone running iOS (version 15 or higher) or Android (version 8 or higher) that will be continuously available for the duration of the study.

Exclusion criteria

Exclusion criteria: 1. Not able to give informed consent 2. Insufficient language abilities in the available languages: German

Design outcomes

Primary

Measure	Time frame
1. Recruitment measured using the weekly recruitment rate in the week of the highest recruitment rate 2. Randomization measured using the number of participants successfully randomized after informed consent 3. Retention measured using the percentage of retained participants at post-intervention and 4-week follow-up 4. Satisfaction and usability measured using subscales of the mHealth App Usability Questionnaire (MAUQ) at post-intervention 5. Participant adherence measured using the number of attended sessions and the number of completed EMA as well as EMI tasks during the intervention 6. Mental well-being measured using the Warwick–Edinburgh Mental Well-being Scale (WEMWBS) at baseline, post-intervention, 4-week follow-up, and a subsequent wave of the online cohort 7. Depression and anxiety measured using the Patient Health Questionnaire-4 (PHQ-4) at baseline, post-intervention, 4-week follow-up, and a subsequent wave of the online cohort 8. Health-related quality of life measured using one item of the EQ-5D-5L (EuroQol Group) at baseline, postintervention, and 4-week follow-up 9. Psychological distress measured using one item of the psyBel/FGBU measure at baseline, post-intervention, 4-week follow-up, and subsequent wave of the online cohort	—

Measure

Time frame

1. Recruitment measured using the weekly recruitment rate in the week of the highest recruitment rate 2. Randomization measured using the number of participants successfully randomized after informed consent 3. Retention measured using the percentage of retained participants at post-intervention and 4-week follow-up 4. Satisfaction and usability measured using subscales of the mHealth App Usability Questionnaire (MAUQ) at post-intervention 5. Participant adherence measured using the number of attended sessions and the number of completed EMA as well as EMI tasks during the intervention 6. Mental well-being measured using the Warwick–Edinburgh Mental Well-being Scale (WEMWBS) at baseline, post-intervention, 4-week follow-up, and a subsequent wave of the online cohort 7. Depression and anxiety measured using the Patient Health Questionnaire-4 (PHQ-4) at baseline, post-intervention, 4-week follow-up, and a subsequent wave of the online cohort 8. Health-related quality of life measured using one item of the EQ-5D-5L (EuroQol Group) at baseline, postintervention, and 4-week follow-up 9. Psychological distress measured using one item of the psyBel/FGBU measure at baseline, post-intervention, 4-week follow-up, and subsequent wave of the online cohort

—

Secondary

Measure	Time frame
There are no secondary outcome measures.	—

Countries

Germany

Contacts

Public ContactChristian Rauschenberg

christian.rauschenberg@zi-mannheim.de+49 621 1703-1929

Outcome results

None listed

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