CompletedNot Applicable

The Design and Evaluation of a Digital Physical Activity Intervention for Individuals With Severe Mental Illness in an Irish Mental Health Residential Setting

Ireland18 participantsStarted 2024-02-01

Plain-language summary

The goal of this clinical trial is to collaboratively develop and evaluate Active Ease, a co-designed, web-based digital physical activity application, to promote and maintain physical activity levels among individuals with severe mental illness in an Irish mental health residential care setting. The main questions it aims to answer are: * What are the barriers and facilitators individuals with severe mental illness face when participating in physical activity within an Irish mental health residential setting? * What is the potential role of digital technologies in promoting and maintaining physical activity engagement for individuals with severe mental illness? * Can a co-designed digital physical activity intervention, developed with HSE clinicians and service users, effectively promote and maintain physical activity levels among individuals with severe mental illness in an Irish mental health residential setting? Researchers will compare two intervention houses receiving Active Ease to one control house receiving usual care. Participants will: * Engage with Active Ease across two consecutive intervention phases * Wear a GENEActiv accelerometer for seven consecutive days at each data collection timepoint * Have their body mass index recorded * Participate in semi-structured interviews about their experience of Active Ease * Complete a follow-up assessment at +12 weeks post-Phase Two

Who can participate

Age range

19 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Aged 19+ * Have an SMI of schizophrenia, bipolar disorder, or psychosis. * A service user within one of three HSE mental health residential houses. Capacity to understand the research and consent to the research (Assisted Decision-Making (Capacity) Act 2015). * Approved by their clinician. Exclusion Criteria: * No SMI diagnosis * Acute psychiatric episode at the time of recruitment * Service users who are unwell/ distressed

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Physical Activity Levels

Timeframe: Change from baseline to approximately 18 months

Trial details

NCT IDNCT07746609

SponsorMunster Technological University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-31

View on ClinicalTrials.gov More Severe Mental Illness trials