A feasibility study of a smartphone app to support mental well-being in people with Long COVID

Feasibility of trial methodology, intervention delivery, and initial outcome signals of an app-based ecological momentary intervention to promote mental well-being: a feasibility Trial within Cohort study in individuals with Long COVID

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN12510191

Enrollment

Registered

2026-06-17

Start date

2026-08-01

Completion date

Unknown

Last updated

2026-07-20

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

Conditions

Mental health promotion in individuals with Long COVID enrolled in a digital cohort Mental and Behavioural Disorders

Interventions

Current interventions as of 03/07/2026: In a two-arm, parallel-group, randomised controlled Trial within Cohort study (TwiC), registered individuals from a digital cohort (DigiHero Study

https://webszh.uk-halle.de/digihero/en/digi-hero-study/) with Long COVID identified as eligible in this cohort will be randomly assigned to either the experimental condition, which receives the EMI in

Eligibility

Sex/Gender

All

Age

18 Years to 100 Years

Inclusion criteria

Inclusion criteria: Current key inclusion criteria as of 03/07/2026: 1. At least 18 years or older 2. Access to a smartphone running on iOS or Android, which will be continuously available for the duration of the study. 3. Registered in the DigiHero Cohort 4. Presence of Long COVID _____ Previous key inclusion criteria: 1. At least 18 years or older 2. Access to a smartphone running on iOS or Android, which will be continuously available for the duration of the study. 3. Registered in the DigiHero Cohort 4. Presence of post-acute infection syndrome (PAIS)

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
Recruitment measured using the weekly recruitment rate at the week of the highest recruitment;Randomization measured using the number of participants successfully randomized at baseline after informed consent;Satisfaction and usability measured using subscales of the mHealth App Usability Questionnaire (MAUQ) at post-intervention;Participant adherence measured using the number of completed EMA as well as EMI tasks at intervention as well as whether participants learned three core exercises within 14 days;Retention measured using the percentage of retained participants at post-intervention and follow-up;Mental well-being measured using the Warwick–Edinburgh Mental Well-being Scale (WEMWBS) at baseline, post-intervention, and follow-up	—

Measure

Time frame

Recruitment measured using the weekly recruitment rate at the week of the highest recruitment;Randomization measured using the number of participants successfully randomized at baseline after informed consent;Satisfaction and usability measured using subscales of the mHealth App Usability Questionnaire (MAUQ) at post-intervention;Participant adherence measured using the number of completed EMA as well as EMI tasks at intervention as well as whether participants learned three core exercises within 14 days;Retention measured using the percentage of retained participants at post-intervention and follow-up;Mental well-being measured using the Warwick–Edinburgh Mental Well-being Scale (WEMWBS) at baseline, post-intervention, and follow-up

—

Countries

Germany

Contacts

Public ContactUlrich;Christian Reininghaus;Rauschenberg

;

ulrich.reininghaus@zi-mannheim.de;christian.rauschenberg@zi-mannheim.de+49 (0)62117031931;+49 (0)621 17031929

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jul 23, 2026