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

NCT07746609 | Completed

• 3 other identifiers: MTU-HREC-FER-23-039-A18/CRT/6222ECM 01/2026/PUB
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Severe Mental Illness; Health Professionals

Keywords

Severe mental illness; Physical Activity; Digital intervention; Co-design; RE-AIM; COM-B; Ireland; Residential care; Digital health

Outcome Measures

Primary Outcomes (1)

• Physical Activity Levels

  Physical activity levels were assessed objectively using a wrist-worn GENEActiv accelerometer worn for seven consecutive days at each time point. Data were processed using ActivInsights software and analysed in SPSS. Outcome variables included steps, light physical activity, moderate physical activity, vigorous physical activity, steps and sedentary behaviour.

  Change from baseline to approximately 18 months

Secondary Outcomes (2)

• Body Mass Index

  Change from baseline to approximately 18 months

• Feasibility and Acceptability of Active Ease

  From baseline to approximately 18 months.

Study Arms (2)

Active Ease Intervention Group

EXPERIMENTAL

Participants in two intervention houses received access to Active Ease, a co-designed digital physical activity web-based application. Phase One involved 10 weeks of researcher-led support. Following co-design interviews, Phase Two lasted six weeks with clinicians independently facilitating physical activity engagement.

Behavioral: Active Ease Digital Physical Activity Intervention

Control Group (Usual Care)

NO INTERVENTION

Participants in the control house continued with their usual residential care without access to Active Ease or any structured physical activity intervention.

Interventions

Active Ease Digital Physical Activity Intervention BEHAVIORAL

Active Ease is a co-designed digital-physical activity web-based application developed for individuals with severe mental illness in Irish mental health residential settings. The platform was adapted from the Move More Toolkit and informed by feedback from Public and Patient Involvement service users and clinicians. Active Ease includes an educational homepage on the benefits of physical activity and a range of physical activities with guided visual demonstrations, including videos and images. The intervention was delivered across two consecutive phases: Phase One lasted 10 weeks with the researcher acting as a digital navigator and physical activity facilitator; Phase Two lasted six weeks with the researcher supporting clinicians to independently facilitate physical activity engagement among service users. Environmental adaptations in Phase Two included screen mirroring Active Ease to communal televisions and placement of visual aids and a guidebook within the residential settings. Th

Also known as: Active Ease

Active Ease Intervention Group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• No SMI diagnosis
• Acute psychiatric episode at the time of recruitment
• Service users who are unwell/ distressed

Sponsors & Collaborators

• Munster Technological University: lead
• Health Service Executive (HSE): collaborator
• Loughborough University: collaborator
• Taighde Éireann - Research Ireland: collaborator

Study Sites (1)

Munster Technological University

Cork, T12P928, Ireland

Location

Related Publications (3)

• Forde SA, Coppinger T, Rea S, Hanrahan S. The effectiveness of digital tools in physical activity interventions for individuals with severe mental illness: a scoping review. Disabil Rehabil Assist Technol. 2025 Nov;20(8):2594-2615. doi: 10.1080/17483107.2025.2508938. Epub 2025 Jun 1.

  PMID: 40450697 BACKGROUND

• Forde SA, Rea S, Racine E, Coppinger T. The role of public and patient involvement in designing a web-based, physical activity application for individuals with severe mental illness. Res Involv Engagem. 2025 Jul 21;11(1):86. doi: 10.1186/s40900-025-00735-x.

  PMID: 40691811 RESULT

• Forde, S.A. et al. (2026) 'Understanding Physical Activity and Digital Technology Engagement Among Individuals with Severe Mental Illness in Irish Mental Health Residential Settings: A Qualitative Study', Journal of Psychosocial Rehabilitation and Mental Health [Preprint]. Available at: https://doi.org/10.1007/s40737-026-00541-y.

  RESULT

Related Links

• Co-designed digital physical activity web based platform, Active Ease.

MeSH Terms

Conditions

Mental Disorders; Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Candidate

Model Details: A clustered feasibility randomised controlled trial design was employed. Two residential houses were randomly assigned as intervention houses and one as a control house. Randomisation was conducted at the house level rather than the individual participant level.

Study Record Dates

• First Submitted: July 29, 2026
• First Posted: August 5, 2026
• Study Start: February 1, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: August 6, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)