The PHAstER Trial: Physical Health Assistance in Early Recovery of Psychosis
orygenDataset description
The dataset captures a range of variables from a randomized controlled trial (RCT) evaluating the impact of a physical health nurse on improving the physical health of young people experiencing a first episode of psychosis. Key variables include participant demographics, metabolic health indicators (e.g., body weight, BMI, waist circumference, blood pressure, fasting glucose, cholesterol), and measures of physical activity tracked via actigraphs and the Simple Physical Activity Questionnaire (SIMPAQ). The dataset also includes secondary outcomes such as symptom severity (assessed via BPRS and SANS), psychological functioning (SOFAS), sexual health, substance use (ASSIST), and sleep quality (PSQI, ISI, MEQ). Additionally, satisfaction with services is recorded through the Youth (Mental Health) Service Satisfaction Scale (YSSS). Measurements were taken at multiple timepoints: baseline, 4 weeks, 8 weeks, 12 weeks, and 26 weeks post-intervention.
Source Study
Purpose:
Phase:
Trial acronym
Not available
Trial ID
ACTRN12618001222235
Funding
University, University of Melbourne Early Career Researcher Grant
Scientific enquiries
Dr Orygen Research office
Brief Summary
The aim of this research is to determine whether the inclusion of a physical health nurse will improve the physical health of young people with a first episode of psychosis. The rationale behind this study is that numerous studies have demonstrated that young people who develop a first episode of psychosis have poorer physical health compared to their peers who do not have psychotic disorders, specifically, they are more likely to be overweight or obese, to be inactive, to have a poor diet and t .... Read more
Key Inclusion Criteria
- Eligible for EPPIC and this involves: residing within the geographically defined catchment area, be aged between 15 and 24 and experiencing a first episode of psychosis, defined as experiencing at least one positive psychotic symptom on a daily basis for at least one week, - Ability to provide informed consent. - Have at least 12 weeks of care remaining at EPPIC
Key Exclusion Criteria
- More than 30 days total exposure to the minimum effective dose for a psychotic disorder (reference – Maudsley guidelines)
Can healthy volunteers participate?
No
Population
Sample Size 88
Min. age 15 Years
Max. age 24 Years
Sex Both males and females
Condition category Weight gain during first episode of psychosis
Condition code Mental Health
Intervention
Intervention code Prevention , Lifestyle
Brief name: Physical health nurse Description: Participants allocated to the intervention group will have a physical health nurse as part of their treating team for a 12-week period. The purpose of the physical health nurse is to provide coordination of the physical health services for the young people who attend the Early Psychosis Prevention and Intervention Centre (EPPIC) at Orygen Youth Health. This role includes performing physical health screening (metabolic monitoring) and facilitating cl .... Read more
Comparison
Control group Active
The control group will be "treatment as usual". That is, a physical health nurse will not be assigned to their treating team (so it will consist of a case manager and doctor). All people in this group will still have access to all of the physical health interventions available to the intervention group.
Outcomes
Outcome: proportion of individuals who gain >7% of body weightTimepoint: at commencement of intervention, and at 4 weeks, 8 weeks, 12 weeks (primary time point), and 26 weeks post-commencement
Will the study consider sharing individual participant data?
Yes
Who can request access to individual participant data?
Data will potentially be available to researchers from not-for profit organisations, commercial organisations or other based in any location. All data requests will be considered by the data custodian and the primary sponsor on a case-by-case basis. Requests must include a methodologically sound proposal. Specific conditions of use may apply and will be specified in a data sharing agreement (or similar) that the requester must agree to before access is granted. For further information, see Orygen data management policy.
Are there any conditions for requesting access to individual participant data?
-
What individual participant data might be shared?
Individual participant data not covered above
All data, anonymised
What types of analyses could be done with individual participant data?
To any type of analyses. Assessed on a case-by-case basis.
Are there extra considerations when requesting access to individual participant data?
No
When can requests for individual data be made (start and end dates)?
From: Data are available immediately for an indefinite time.
To: -