Randomised controlled feasibility trial of an intervention to increase activity and reduce sedentary behaviour in people with severe mental illness: Walking fOR Health (WORtH) study.
The results of this study support the feasibility of the WORtH intervention in adults with severe mental illness, with 90% target recruitment, 94% retention, and >80% adherence, and findings will be used to optimise the design of a definitive RCT.
Key Findings
Results
The WORtH feasibility trial met 90% of its recruitment target, enrolling 54 participants with severe mental illness across four community mental health teams in the UK and Ireland.
54 participants were recruited (25 male, 29 female; mean age 51.6 years)
Eligible participants had a diagnosis of a severe mental illness (SMI) and no contraindications to participating in physical activity
Recruitment and intervention delivery took place within four community mental health teams in the UK and Ireland
The study met 90% of its target recruitment figure
Results
Retention was high, with 94% of participants providing follow-up data.
94% of participants provided follow-up data
This retention rate supports the feasibility of conducting a definitive RCT
Participants were randomised to either the 13-week WORtH intervention or an education-only control condition
Results
Adherence to the allocated intervention and engagement with all core intervention components exceeded 80%.
Adherence to allocated intervention was >80%
Engagement with all core intervention components was >80%
The WORtH intervention comprised education, activity tracking, and health coaching delivered over 13 weeks
The control condition consisted of a one-off education session
Results
Qualitative feedback from participants indicated high levels of satisfaction with the WORtH intervention.
Qualitative feedback indicated high levels of satisfaction
Acceptability was listed as one of the primary feasibility outcomes alongside recruitment, retention, and adherence
High satisfaction supports the acceptability of the intervention as delivered by community mental health teams
Results
Point estimates indicated a mean increase of 8.6 min/day of moderate-vigorous physical activity (MVPA) in the intervention group compared with 1.0 min/day in the control group.
Intervention group: baseline MVPA 54.7 min/day (95% CI 39.5 to 70.0); follow-up 63.3 min/day (95% CI 50.1 to 76.4)
Control group: baseline MVPA 42.1 min/day (95% CI 24.6 to 59.6); follow-up 43.1 min/day (95% CI 29.6 to 56.5)
MVPA was measured using the Axivity AX3 device
MVPA was the intended primary outcome for a definitive trial
This was a feasibility trial and was not powered to detect statistically significant differences between groups
Results
Valid device-measured MVPA data were obtained from 90% of participants at baseline and 75% of participants at post-intervention.
90% of participants provided valid device-measured MVPA data at baseline
75% of participants provided valid device-measured MVPA data at post-intervention follow-up
Physical activity was measured using the Axivity AX3 accelerometer device
The drop in valid data from baseline (90%) to follow-up (75%) is a consideration for the design of a definitive RCT
Both device-measured and self-reported PA and SB were assessed as clinical outcomes
Background
People with severe mental illness engage in less physical activity and more sedentary behaviour than the general population, contributing to poorer physical health outcomes.
The WORtH study was designed to address the gap in PA and increased SB observed in people with SMI
The intervention was delivered by community mental health teams, targeting this population in a naturalistic setting
Clinical outcomes assessed included device-measured and self-reported PA and SB, body anthropometry, physical function, and mental well-being
What This Means
This research tested whether a walking and activity program called WORtH (Walking fOR Health) was practical and acceptable for people with severe mental illness (SMI), such as schizophrenia or bipolar disorder. People with SMI tend to be much less physically active than the general population and spend more time sitting, which contributes to worse physical health and shorter life expectancy. The 13-week WORtH program combined education about physical activity, wearable activity trackers, and health coaching sessions, and was delivered through community mental health teams in the UK and Ireland. A comparison group received only a single education session.
The study found that the program was highly feasible: 90% of the recruitment target was met, 94% of participants completed the study, and more than 80% of participants stuck with the program and engaged with all its components. Participants also reported high satisfaction with the program. Those in the WORtH intervention group showed a mean increase of 8.6 minutes per day of moderate-to-vigorous physical activity (like brisk walking) by the end of the program, compared to only 1 minute per day in the control group, though this was a small feasibility study not designed to prove effectiveness.
This research suggests that a walking and behavior change program delivered through mental health services is practical, well-received, and engaging for people with severe mental illness. The findings will be used to refine the design of a larger, definitive clinical trial to properly test whether WORtH can significantly improve physical activity levels in this underserved population.
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McDonough S, Dillon M, McDonough C, McAuley J, Clarke M, Murphy C, et al.. (2026). Randomised controlled feasibility trial of an intervention to increase activity and reduce sedentary behaviour in people with severe mental illness: Walking fOR Health (WORtH) study.. BMJ open. https://doi.org/10.1136/bmjopen-2025-107567