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Trial registered on ANZCTR
Registration number
ACTRN12618001222235
Ethics application status
Approved
Date submitted
17/07/2018
Date registered
20/07/2018
Date last updated
18/07/2024
Date data sharing statement initially provided
18/07/2024
Date results provided
18/07/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
Effect of involving a physical health nurse in the care of young people with a first episode of psychosis on the prevention of weight gain
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Scientific title
Effect of involving a physical health nurse in the care of young people with a first episode of psychosis on the prevention of weight gain compared to treatment as usual: A randomised trial
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Secondary ID [1]
295388
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None
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Universal Trial Number (UTN)
U1111-1216-6816
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Trial acronym
PHAstER (Physical Health Assistance in Early Recovery of Psychosis)
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Weight gain during first episode of psychosis
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Condition category
Condition code
Mental Health
307584
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Psychosis and personality disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
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 clients attending the services at Orygen Youth Health that have been established to address the physical health of young people, including but not limited to exercise physiologists, dieticians, gym group, yoga group, and 'Tackling tobacco' intervention in conjunction with QUIT Victoria. The physical health nurse will have weekly contact with participants via a combination of face-to-face and telephone contact, typically separate to the treating team appointments.
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Intervention code [1]
301758
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Prevention
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Intervention code [2]
301759
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Lifestyle
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Comparator / control treatment
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.
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Control group
Active
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Outcomes
Primary outcome [1]
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proportion of individuals who gain >7% of body weight
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Assessment method [1]
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Timepoint [1]
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at commencement of intervention, and at 4 weeks, 8 weeks, 12 weeks (primary time point), and 26 weeks post-commencement
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Secondary outcome [1]
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proportion of participants with components of metabolic syndrome, assessed via BMI (using a stadiometer and digital scale to measure height and weight), waist circumference (tape measure), blood pressure (digital sphygmomanometer), and fasting glucose, HbA1c and fasting cholesterol (determined via a fasting blood test that will be sent to a pathology lab).
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Assessment method [1]
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Timepoint [1]
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height, fasting glucose, HbA1c, fasting cholesterol: at commencement of intervention, and at 12 weeks and 26 weeks post-commencement weight, waist circumference, blood pressure: at commencement of intervention, and at 4 weeks, 8 weeks, 12 weeks, and 26 weeks post-commencement
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Secondary outcome [2]
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level of physical activity assessed using the Simple Physical Activity Questionnaire (SIMPAQ) and an actigraph that will measure number of steps and quantity of exercise
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Assessment method [2]
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Timepoint [2]
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at commencement of intervention, and at 12 weeks and 26 weeks post-commencement
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Secondary outcome [3]
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level of symptomology assessed via the Brief Psychiatric Rating Scale (BPRS) and the Schedule for Assessment of Negative Symptoms (SANS)
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Assessment method [3]
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Timepoint [3]
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at commencement of intervention, and at 12 weeks and 26 weeks post-commencement
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Secondary outcome [4]
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level of psychological functioning assessed via the Social and Occupational Functioning Assessment Scale (SOFAS)
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Assessment method [4]
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Timepoint [4]
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at commencement of intervention, and at 12 weeks and 26 weeks post-commencement
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Secondary outcome [5]
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level of sexual health and contraceptive use, assessed via an internal questionnaire developed at Orygen Youth Health
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Assessment method [5]
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Timepoint [5]
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at commencement of intervention, and at 12 weeks and 26 weeks post-commencement
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Secondary outcome [6]
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level of substance use assessed via the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)
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Assessment method [6]
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Timepoint [6]
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at commencement of intervention, and at 12 weeks and 26 weeks post-commencement
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Secondary outcome [7]
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quality of sleep assessed via an actigraph, the Pittsburgh Sleep Quality index (PSQI), the Insomnia Severity Index (ISI), and the Morningness-Eveningness questionnaire (MEQ)
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Assessment method [7]
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Timepoint [7]
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at commencement of intervention, and at 12 weeks and 26 weeks post-commencement
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Secondary outcome [8]
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satisfaction with services assessed via the Youth (Mental Health) Service Satisfaction Scale (YSSS)
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Assessment method [8]
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Timepoint [8]
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at commencement of intervention, and at 12 weeks and 26 weeks post-commencement
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Eligibility
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
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Minimum age
15
Years
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Maximum age
24
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- More than 30 days total exposure to the minimum effective dose for a psychotic disorder (reference – Maudsley guidelines)
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The researchers involved in the diagnosis and eligibility screening of participants will not be privy to the allocation sequence, which will be centrally randomised by a separate statistician who will allocate on a per-participant basis following informed consent.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation), stratified according to sex and BMI.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
SAMPLE SIZE ESTIMATION & JUSTIFICATION
A total of 88 participants will be recruited, which will allow for attrition of just over 10%. The power analysis conducted to obtain this sample size is presented below.
POWER CALCULATIONS
It has been demonstrated that at least 50% of young people with a first episode of psychosis will gain >7% of their body weight in the first 12 weeks of treatment, even with medications that have been marketed as ‘weight neutral’. The HeAL declaration sets out a target of no more than 25% of young people with a first episode of psychosis gaining >7% of their body weight following treatment for a first episode of psychosis. Therefore, with an estimated proportion of 50% in the non-intervention group and 20% in the intervention group gaining clinically significant weight gain (>7% body weight), with 80% power at 95% significance level would require a total sample size of 78 with 39 in each group. Therefore, this study will aim to recruit a total of 88 participants with a first episode of psychosis from the Early Psychosis Prevention and Intervention Centre (EPPIC) at Orygen Youth Health to allow for approximately 10% attrition. Disengagement rates can be as high as 30% in those with a first episode of psychosis, however this tends to occur in the periods six months after initial presentation. Furthermore, the primary outcome of weight gain is measured routinely by the treating team and therefore it will be possible to obtain information on individuals for the intention to treat analysis.
STATISTICAL METHODS TO BE UNDERTAKEN
The primary outcome will be determined using chi-square analysis comparing the two expected vs observed outcome of proportion of individuals who gained >7% of body weight in the two groups.
In order to control for some potential confounders, which may not have been addressed by randomization, a further binary logistic regression analysis will be performed, with all of the potential confounders (such as age and medication prescribed ) in the first block and the treatment allocation in the second block.
Chi-square analysis will also be conducted for certain secondary outcomes (components of metabolic syndrome, tobacco use, contraception use). Descriptive statistics will be calculated for all measures. Key sleep measures will be compared to actigraph measures using Bland-Altman concordance analysis.
Young people who become pregnant during the course of the study can still remain involved in the study and can complete the study intervention and follow-up assessments. However they will be excluded from the primary outcome analysis, as their expected weight gain during the pregnancy would confound the primary outcome. However, the data collected from any participant who becomes pregnant will contribute towards secondary outcomes (excluding contraception use).
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
25/07/2018
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Actual
22/08/2018
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Date of last participant enrolment
Anticipated
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Actual
14/04/2021
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Date of last data collection
Anticipated
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Actual
19/10/2021
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Sample size
Target
88
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Accrual to date
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Final
88
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Orygen Youth Health - Sunshine - Sunshine
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Recruitment postcode(s) [1]
23226
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3020 - Sunshine
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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University of Melbourne Early Career Researcher Grant
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Address [1]
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Centre for Youth Mental Health The University of Melbourne 35 Poplar Rd, Parkville VIC 3052
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Country [1]
299980
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Australia
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Funding source category [2]
300138
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Charities/Societies/Foundations
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Name [2]
300138
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Morris Family Foundation
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Address [2]
300138
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Eltham VIC 3095
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Country [2]
300138
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Australia
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Primary sponsor type
Other Collaborative groups
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Name
Orygen, the National Centre of Excellence in Youth Mental Health
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Address
Centre for Youth Mental Health
The University of Melbourne
35 Poplar Rd, Parkville VIC 3052
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Country
Australia
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Secondary sponsor category [1]
299360
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Individual
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Name [1]
299360
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Dr Brian O'Donoghue
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Address [1]
299360
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Centre for Youth Mental Health The University of Melbourne 35 Poplar Rd, Parkville VIC 3052
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Country [1]
299360
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
300837
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Melbourne Health Human Research Ethics Committee
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Ethics committee address [1]
300837
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Office for Research The Royal Melbourne Hospital Level 2 South West 300 Grattan Street Parkville VIC 3050
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Ethics committee country [1]
300837
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Australia
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Date submitted for ethics approval [1]
300837
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Approval date [1]
300837
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24/05/2018
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Ethics approval number [1]
300837
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HREC/18/MH/77
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Summary
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 to smoke. In addition, some of the medications that are prescribed for psychosis can lead to weight gain, therefore it is important that we address or prevent these physical health problems. We also know that young people with a first episode of psychosis are more likely to have poorer sexual health than their peers, in that they are more likely to engage in high risk sexual behaviours, such as not using contraception. Furthermore, there is evidence emerging that sleep is a very important component of physical and mental well being, so we would like to learn more about the characteristics of sleep in young people with a first episode of psychosis.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Brian O'Donoghue
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Address
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St Vincent's University Hospital Elm Park Dublin 4
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Country
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Ireland
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Phone
84978
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+353876301145
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Fax
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Email
84978
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[email protected]
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Contact person for public queries
Name
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Orygen Research office
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Address
84979
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Orygen, 35 Poplar Rd, Parkville VIC 3052
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Country
84979
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Australia
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Phone
84979
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+61 0399669100
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Fax
84979
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Email
84979
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[email protected]
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Contact person for scientific queries
Name
84980
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Orygen Research office
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Address
84980
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Orygen, 35 Poplar Rd, Parkville VIC 3052
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Country
84980
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Australia
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Phone
84980
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+61 03 99669100
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Fax
84980
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Email
84980
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
•
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.
Conditions for requesting access:
•
-
What individual participant data might be shared?
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All data, anonymised
What types of analyses could be done with individual participant data?
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To any type of analyses. Assessed on a case-by-case basis.
When can requests for individual participant data be made (start and end dates)?
From:
Data are available immediately for an indefinite time.
To:
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Where can requests to access individual participant data be made, or data be obtained directly?
•
Access can be requested via the Health Data Australia catalogue (https://researchdata.edu.au/health). Search for the ANZTRN number in the catalogue to find datasets associated with this trial.
Are there extra considerations when requesting access to individual participant data?
No
What supporting documents are/will be available?
No Supporting Document Provided
Type
Citation
Link
Email
Other Details
Attachment
Study protocol
https://onlinelibrary.wiley.com/doi/10.1111/eip.12884
Results publications and other study-related documents
Documents added manually
Type
Is Peer Reviewed?
DOI
Citations or Other Details
Attachment
Plain language summary
No
Factors that contribute to the early mortality obs...
[
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Study results article
Yes
O'Donoghue B, Mifsud N, Castagnini E, Langstone A,...
[
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Documents added automatically
No additional documents have been identified.
Download to PDF