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

Project Aclú - Digital Tool(s) to Promote Physical Activity Within an Irish Residential Care Setting.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07746609
Enrollment
18
Registered
2026-08-05
Start date
2024-02-01
Completion date
2025-12-31
Last updated
2026-08-06

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

Conditions

Health Professionals, Severe Mental Illness

Keywords

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

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

Detailed description

Active Ease is a co-designed digital-physical activity web-based application developed for individuals with severe mental illness (SMI) in Irish mental health residential settings. The platform was adapted from the Move More Toolkit (Anthony et al., 2024), originally developed at Loughborough University, and informed by Public and Patient Involvement (PPI) feedback from service users and clinicians. Active Ease includes an educational homepage and a range of physical activities with guided visual demonstrations, including videos and images. The intervention was underpinned by the Capability, Opportunity, Motivation - Behaviour (COM-B) model and evaluated using the RE-AIM framework. A clustered randomised controlled trial design was employed across three Irish mental health residential houses. Two houses were randomly assigned as intervention houses and one as a control. The intervention was delivered across two consecutive phases. Phase One involved a 10-week researcher-led pilot in which the researcher served as a digital navigator, supporting service users in engaging with Active Ease individually or in groups. Following co-design interviews with service users and clinicians, iterative refinements were made to Active Ease for Phase Two. Phase Two lasted six weeks and shifted its focus to empowering clinicians to independently facilitate service users' engagement in physical activity, with the researcher adopting a facilitative role. Environmental adaptations introduced in Phase Two included screen mirroring Active Ease to communal televisions and placement of visual aids and a guidebook within the residential settings. Follow-up data were collected at +12 weeks post-Phase Two to evaluate the maintenance of Active Ease engagement and early indicators of sustainability. Qualitative data were analysed using reflexive thematic analysis informed by Braun and Clarke (2019), with findings mapped onto the RE-AIM framework.

Interventions

BEHAVIORALActive Ease Digital Physical Activity Intervention

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

Sponsors

Munster Technological University
Lead SponsorOTHER
Health Service Executive (HSE)
CollaboratorUNKNOWN
Loughborough University
CollaboratorOTHER
Taighde Éireann - Research Ireland
CollaboratorUNKNOWN

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Physical Activity LevelsChange from baseline to approximately 18 monthsPhysical 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.

Secondary

MeasureTime frameDescription
Body Mass IndexChange from baseline to approximately 18 monthsBMI was calculated from weight and height measurements (kg/m²). Weight was measured using a calibrated electronic scale (Seca Model 875), and height was obtained by a clinical psychologist.
Feasibility and Acceptability of Active EaseFrom baseline to approximately 18 months.Semi-structured interviews were conducted with service users and clinicians at baseline, post-Phase One, and +12 weeks follow-up. Baseline interviews were conducted as part of a cross-sectional study reported separately. Post-Phase One interviews informed iterative refinements to Active Ease for Phase Two through a co-design process. Interviews were analysed using reflexive thematic analysis informed by Braun and Clarke (2019) and mapped onto the RE-AIM framework. Post-Phase One interviews focused on Reach, Effectiveness, Adoption and Implementation dimensions. Follow-up interviews focused on the Maintenance dimension.

Countries

Ireland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 7, 2026