Supporting Physical Activity through Co-production in people with Severe Mental Illness (SPACES): a pragmatic randomised controlled trial

Not Applicable

• Conditions: Increase in physical activity in people with severe mental illness; Mental and Behavioural Disorders

• Registration Number: ISRCTN23019026
• Lead Sponsor: Sheffield Health and Social Care NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-08-07
• Last Update Posted: 19 August 2024
• Study Completion: 2027-03-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 736

Inclusion Criteria

1.Aged 18 years or older
2.ICD-10 or DSM-V diagnosis of SMI as documented in GP or psychiatric notes (schizophrenia (F20 and subcodes); schizoaffective disorder (F25 and subcodes); other psychotic and delusional disorders (not of organic origin) (F21-F24 and F26-F29 and subcodes); bipolar and manic episodes (F30 and F31 and subcodes)).
3.Are able to walk unaided
4.Willing to wear an accelerometer

Exclusion Criteria

1.People who lack capacity to participate
2.Primary diagnosis of drug or alcohol abuse
3.Medical contraindication of physical activity as ascertained by GP or mental health team
4.Already physically active, defined as >300 minutes/week of self-reported moderate-to-vigorous physical activity (MVPA)
5.Non-English speakers
6.People who took part in the feasibility study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Objective accelerometer-derived minutes per day of Moderate to Vigorous Physical Activity (MVPA) measured at 6-months post randomisation

Secondary Outcome Measures

Name	Time	Method
1. Data on physical activity (light physical activity and MVPA) and sedentary behaviour will be collected by wrist worn accelerometers at baseline, 3-, 6- and 12-months post randomisation. <br>2. The Simple Physical Activity Questionnaire (SIMPAQ) will be used to measure self-reported physical activity and sedentary behaviour at baseline, 3-, 6- and 12-months post randomisation. <br><br>Other secondary outcomes measured at 3, 6 and 12 months:<br>3. Health behaviours (diet and smoking)<br>4. Body mass index (kg/m²)<br>5. Depression (PHQ-9)<br>6. Anxiety (GAD-7)<br>7. Loneliness (UCLA-3 item)<br>8. Health-related quality of life (EQ5D, REQoL)<br>9. Healthcare resource use and predictive behavioural questionnaire.