Increasing physical activity levels in adults with severe mental ill health (SMI) Mental and Behavioural Disorders
Conditions
Interventions
Participants are randomised via block randomisation with a separate schedule for each site/centre to receive either:
1. Usual care alone
2. Usual care plus an 18-week physical activity intervention de
Sponsors
Sheffield Health and Social Care NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Aged =18 years 2. Schizophrenia and other non-organic psychoses (ICD F20 -F29 and subcodes or DSM equivalent), and Bipolar Disorder and manic episodes (ICD F30 and F31 and subcodes and DSM equivalent) 3. Able to walk unaided
Exclusion criteria
Exclusion criteria: 1. Lack capacity to participate 2. Primary diagnosis of drug or alcohol abuse 3. Have a medical contraindication of physical activity 4. Already physically active, defined as currently doing >300 min/week of self-reported moderate to vigorous physical activity 5. Unwilling to wear accelerometer 6. Non-English speakers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Acceptability of the intervention measured using: 1.1. The Acceptability Intervention Measure (AIM) at 6 months post-randomisation (intervention participants only) 1.2. Intervention uptake, attendance, and attrition throughout the study 1.3. Interviews with intervention participants and intervention facilitators at 6 months post-randomisation 2. Feasibility of a full-scale trial measured using: 2.1. Participant recruitment data at the end of recruitment 2.2. Monitoring the quantity and quality of accelerometer-derived physical activity data collected at baseline, 3 months post-randomisation, and 6 months post-randomisation 2.3. Interviews with intervention participants and intervention facilitators at 6 months post-randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Physical activity measured using accelerometer data at baseline, 3, and 6 months post-randomisation 2. Sedentary behaviour measured using accelerometer data at baseline, 3, and 6 months post-randomisation 3. Body mass index (BMI) calculated using height and weight measurements at baseline, 3, and 6 months post-randomisation 4. Severity of depression measured using the Patient Health Questionnaire-9 (PHQ-9) at baseline, 3, and 6 months post-randomisation 5. Severty of generalised anxiety disorder measured using the General Anxiety Disorder-7 (GAD-7) questionnaire at baseline, 3, and 6 months post-randomisation 6. Self-reported physical activity and edentary behaviour measured using the Simple Physical Activity Questionnaire (SIMPAQ) at baseline, 3, and 6 months post-randomisation 7. Health-related quality-of-life measured using the EuroQoL 5D-5L (EQ5D-5L) questionnaire at baseline, 3, and 6 months post-randomisation 8. Health-related quality-of-life measured using the Short Form Health Questionnaire - 12 (SF-12) at baseline, 3, and 6 months post-randomisation 9. Mental health-related quality-of-life measured using the Recovering Quality of Life (ReQol) at baseline, 3, and 6 months post-randomisation 10. Healthcare resource use measured using a bespoke healthcare service use questionnaire (collecting participant’s use of primary, secondary, and community healthcare services, with special attention paid to physical activity and mental health related services) at baseline, 3, and 6 months post-randomisation | — |
Countries
England, United Kingdom
Contacts
Public ContactEmily Peckham
Outcome results
None listed