Severe Mental IllnessNCT07746609
The Design and Evaluation of a Digital Physical Activity Intervention for Individuals With Severe Mental Illness in an Irish Mental Health Residential Setting
A study testing Active Ease Digital Physical Activity Intervention in people with Severe Mental Illness and Health Professionals, run by Munster Technological University at 1 site in Ireland.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Severe Mental Illness, Health Professionals
- What is being tested?
- Active Ease Digital Physical Activity Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteIreland
- Study dates
- 1 Feb 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- No SMI diagnosis
- Acute psychiatric episode at the time of recruitment
- Service users who are unwell/ distressed
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Project Aclú - Digital Tool(s) to Promote Physical Activity Within an Irish Residential Care Setting.
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:
Read more
- 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
Read the 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.
- Conditions
- Severe Mental Illness, Health Professionals
- Being tested
- Active Ease Digital Physical Activity Intervention
- Keywords
- Severe mental illness, Physical Activity, Digital intervention, Co-design, RE-AIM, COM-B, Ireland, Residential care, Digital health
- Medical subject headings
- Mental Disorders, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Ease Digital Physical Activity InterventionBehavioural
Also called Active Ease
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline to approximately 18 months
Secondary outcomes (2)
Body Mass Index
BMI 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.
Measured: Change from baseline to approximately 18 months
Feasibility and Acceptability of Active Ease
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.
Measured: From baseline to approximately 18 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2026
- Study start1 Feb 2024
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Severe Mental IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Munster Technological University
- Sponsor type
- University, hospital or other
- Collaborators
- Health Service Executive (HSE), Loughborough University, Taighde Éireann - Research Ireland
- Responsible party
- Principal investigator, Aisling Forde, Munster Technological University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07746609
- Sponsor's protocol ID
- MTU-HREC-FER-23-039-A
- Other IDs
- 18/CRT/6222, ECM 01/2026/PUB
- Status last verified
- Jul 2026
- First submitted
- 29 Jul 2026
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data cannot be shared publicly due to ethical restrictions and GDPR obligations relating to the protection of vulnerable participants with severe mental illness. The study involves individuals with severe mental illness in Irish mental health residential settings, and full data sharing would risk compromising participant anonymity and confidentiality. Data were pseudo-anonymised by an independent clinical psychologist. Anonymised findings are reported in the study publications.
Publications
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.
PubMed 40450697Forde 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.
PubMed 40691811Forde, 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project Aclú - Digital Tool(s) to Promote Physical Activity Within an Irish Residential Care Setting.
- ClinicalTrials.gov ID
- NCT07746609
- Acronym / sponsor ID
- MTU-HREC-FER-23-039-A
- Conditions
- Severe Mental Illness, Health Professionals
- Keywords
- Severe mental illness, Physical Activity, Digital intervention, Co-design, RE-AIM, COM-B, Ireland, Residential care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Munster Technological UniversityUniversity, hospital or other
- Collaborators
- Health Service Executive (HSE), Loughborough University, Taighde Éireann - Research Ireland
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 5 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Active Ease Intervention Group | Experimental | Behavioral: Active Ease Digital Physical Activity InterventionParticipants 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. |
| 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- No SMI diagnosis
- Acute psychiatric episode at the time of recruitment
- Service users who are unwell/ distressed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active Ease Digital Physical Activity InterventionAlso: Active EaseActive 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 | Behavioural | Active Ease Intervention Group |
Primary outcome
Physical Activity Levels
Time frame: Change from baseline to approximately 18 months
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.
2 secondary outcomes
Body Mass Index
Time frame: Change from baseline to approximately 18 months
Feasibility and Acceptability of Active Ease
Time frame: From baseline to approximately 18 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Background: PubMed 40450697Forde 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.
- Results publication: PubMed 40691811Forde 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.
- Results publicationForde, 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.
- Co-designed digital physical activity web based platform, Active Ease.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data cannot be shared publicly due to ethical restrictions and GDPR obligations relating to the protection of vulnerable participants with severe mental illness. The study involves individuals with severe mental illness in Irish mental health residential settings, and full data sharing would risk compromising participant anonymity and confidentiality. Data were pseudo-anonymised by an independent clinical psychologist. Anonymised findings are reported in the study publications.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Ease Digital Physical Activity Intervention in people with Severe Mental Illness and Health Professionals, run by Munster Technological University at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical Activity Levels (time frame: Change from baseline to approximately 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07746609, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.