A FEASIBILITY RANDOMISED CONTROLLED TRIAL OF AN INTERVENTION TO INCREASE PHYSICAL ACTIVITY IN PEOPLE WITH SEVERE MENTAL ILLNESS

S. Howes¹, A. Atkinson², J. Brady³, B. Carroll², M. Clarke⁴, M. Clarke⁵, M. Dillon², L. Donegan⁶, A. Donnelly³, L. Kemps⁶, H. Kerr⁷, E. Lait⁸, D. McArdle², J. McAuley⁷, N. McCullagh⁶, C. McDonough², M. McMahon², C. Murphy⁶, M. Murphy⁹, A. Niven¹⁰, T. O'Neill⁵, J. Seetheraman⁶, M. Tully¹¹, J. Williams¹², I. Wilson⁵, S. McDonough^13,1

¹Ulster University, School of Health Sciences, Newtownabbey, United Kingdom, ²Health Services Executive, Louth, Ireland, ³Western Health and Social Care Trust, Omagh, United Kingdom, ⁴St John of God's, Dublin, Ireland, ⁵Queen's University, Belfast, United Kingdom, ⁶Health Services Executive, Cavan Monaghan, Ireland, ⁷Northern Health and Social Care Trust, Antrim, United Kingdom, ⁸Beaumont Hospital, Dublin, Ireland, ⁹Ulster University, Belfast, United Kingdom, ¹⁰University of Edinburgh, Edinburgh, United Kingdom, ¹¹Ulster University, Newtownabbey, United Kingdom, ¹²King's College London, London, United Kingdom, ¹³RCSI University of Medicine and Health Sciences, School of Physiotherapy, Dublin, Ireland

Background: People with severe mental illness (SMI), such as schizophrenia, psychosis, bipolar affective disorder and major depressive disorder, are less physically active and more sedentary than healthy controls, contributing to poorer physical health outcomes in this population. People with SMI experience unique challenges to increasing their physical activity and reducing their sedentary behaviour which are both directly and indirectly related to their mental health condition. These include amotivation, fatigue, cognitive challenges and sedative effects of psychotropic medication. Hence, there is a need to understand the best way to target physical activity and sedentary behaviour in this population to improve physical health outcomes.

Purpose: The Walking fOR Health (WORtH) study was a feasibility randomised controlled trial aimed at understanding the feasibility and acceptability of a multi-component health behaviour change intervention targeting physical activity and sedentary behaviour in adults with SMI.

Methods: Adults diagnosed with an SMI who were not meeting the physical activity guidelines were recruited and randomised 2:1 to the WORtH intervention or a control group.
Participants allocated to the 13-week WORtH intervention received an education session, a wrist-worn activity monitor and activity diary for self-monitoring, and six coaching sessions for goal-setting and action-coping planning related to physical activity and sedentary behaviour. Clinicians from community mental health teams in the UK and Ireland were trained to deliver the intervention.
Participants allocated to the control group received a one-off education session and written leaflet on the benefits of, and ways to move more and sit less.
Primary outcomes were related to feasibility and acceptability, including recruitment, retention and adherence rates, adverse events and qualitative feedback from participants and clinicians.
Secondary outcome measures include self-reported and accelerometer-measured physical activity and sedentary behaviour (using the Axivity AX3, SIMPAQ and Sedentary Behaviour Questionnaire), anthropometry measures, physical function, mental wellbeing (Warwick-Edinburgh Mental Wellbeing Scale) and measures of motivation (BREQ-2) and psychological needs in exercise (PNSE), measured at baseline and at post-intervention for all participants and at six and 12 months post-intervention for a sub-group of participants.

Results: Fifty-four participants (mean age 51.6 years; 25 male:29 female) were recruited, representing 90% target recruitment (n=54/60). The conversion rate from screening to consent was 30%. We obtained post-intervention data from 94% of participants. Qualitative feedback from n=20 participants and n=6 clinicians suggested high levels of satisfaction with the intervention in terms of content, duration and number of sessions. The step counter watch and coaching sessions were the most important aspects of the intervention. We recorded 85-100% adherence to the core intervention components; e.g. 100% of the intervention group participants wore the wrist-worn activity monitor and 90% attended all six coaching sessions. There were no unexpected or serious adverse events related to the intervention.

Conclusions: Findings of this feasibility randomised controlled trial suggest that the WORtH multi-component health behaviour change intervention is a feasible and acceptable approach to improve activity levels in adults with SMI.

Implications: Findings of this study will be used to refine the study design and intervention for a definitive randomised controlled trial evaluating the effectiveness and cost-effectiveness of the WORtH intervention.

Funding acknowledgements: Cross-border Healthcare Intervention Trials in Ireland Network (CHITIN) programme, Special EU Programmes Body (SEUPB), European Union’s INTERREG VA Programme.

Keywords:
Physical activity
Sedentary behaviour
Mental Health

Topics:
Mental health
Health promotion & wellbeing/healthy ageing/physical activity
Non-communicable diseases (NCDs) & risk factors

Did this work require ethics approval? Yes

Institution: Ulster University

Committee: Office for Research Ethics Committees Northern Ireland

Ethics number: 18/NI/0212