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Trial registered on ANZCTR
Registration number
ACTRN12623000695606
Ethics application status
Approved
Date submitted
14/06/2023
Date registered
29/06/2023
Date last updated
9/05/2024
Date data sharing statement initially provided
29/06/2023
Type of registration
Prospectively registered
Titles & IDs
Public title
Getting into a good headspace: Trial of a brief group-based eating disorder prevention program for young Australians at risk of developing an eating disorder
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Scientific title
Getting into a good headspace: Efficacy trial of implementing a brief group-based eating disorder prevention program in an Australian youth mental health service
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Secondary ID [1]
309953
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None
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Universal Trial Number (UTN)
U1111-1293-8206
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
eating disorder
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body image concerns
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psychological distress
330361
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Condition category
Condition code
Mental Health
327205
327205
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0
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Eating disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Intervention: Attendance at 4 x 1.5hour group psychology sessions following the manualised program of 'The Body Project' by Stice, Rohde & Shaw (2012).
Body Project Group sessions will take place weekly at headspace Camperdown, over 4 weeks. Sessions will last 90mins. Groups will consist of up to 10 participants.
Allocation to the intervention group occurs by 'participant choice' - All consenting participants of the study will be invited to attend the group program and places in the groups will be allocated on a 'first-come' basis.
Groups will be facilitated by a clinical psychology Masters student (under supervision of a senior clinical psychologist) and supported by a co-facilitator (either a second clinical psychology Masters student under supervision or a mental health professional such as a psychologist or social worker).
Group session contents and structure will follow the outlined procedure in the Body Project treatment manual by Stice, Rohde & Shaw (2012).
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Intervention code [1]
326336
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Prevention
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Intervention code [2]
326373
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Treatment: Other
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Comparator / control treatment
Control: treatment-as-usual control group
Consenting participants who complete the measures but who do not partake in the body project intervention group will be able to attend their standard care at the centre and will provide a treatment-as-usual (TAU) control sample.
Standard care at a headspace centre involves completing a comprehensive clinical assessment (the headdss assessment) with a Youth Access Clinician (YAC). Based on the assessment, the YAC and the headspace clinical team make recommendations for suitable treatment and support options for the client both internal and external to the service which may include a consult with the GP, a referral to see a psychologist, work and study support, a psychiatry assessment, referrals to group programs within headspace, and/or referrals to external specialised services. The YAC plays a care coordination role during the client's time access treatment and services via headspace.
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Control group
Active
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Outcomes
Primary outcome [1]
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Eating disorder symptom severity as measured by the Eating Disorder Examination Questionnaire - Short (EDE-QS; Gideon et al., 2016)
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Assessment method [1]
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Timepoint [1]
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Baseline (pre-treatment), Post-treatment (post-conclusion of intervention), One-month follow-up post-conclusion of intervention.
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Primary outcome [2]
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Eating disorder symptom severity as measured by the Inside Out Screener (Bryant et al., 2021).
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Assessment method [2]
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Timepoint [2]
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Baseline (pre-treatment), Post-treatment (post-conclusion of intervention), One-month follow-up post-conclusion of intervention.
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Secondary outcome [1]
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Perspectives on body image as measured by the Perceived Socio-cultural Pressure Scale (PSPS; Stice & Bearman, 2001)
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Assessment method [1]
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Timepoint [1]
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Baseline (pre-treatment), Post-treatment (post-conclusion of intervention), One-month follow-up post-conclusion of intervention.
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Secondary outcome [2]
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Psychological distress (composite outcome encapsulating symptoms of depression, anxiety and stress) as measured by the Depression, Anxiety and Stress Scale (DASS-21; Lovibond & Lovibond, 1995).
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Assessment method [2]
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Timepoint [2]
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Baseline (pre-treatment), Post-treatment (post-conclusion of intervention), One-month follow-up post-conclusion of intervention.
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Secondary outcome [3]
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Psychological distress as measured by the Kessler Psychological Distress Scale (K10; Kessler et al., 2003)
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Assessment method [3]
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Timepoint [3]
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Baseline (pre-treatment), Post-treatment (post-conclusion of intervention), One-month follow-up post-conclusion of intervention.
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Secondary outcome [4]
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Positive self-body image as measured by the Body Appreciation Scale -2 (BAS-2; Tylka & Wood-Barcalow, 2015)
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Assessment method [4]
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Timepoint [4]
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Baseline (pre-treatment), Post-treatment (post-conclusion of intervention), One-month follow-up post-conclusion of intervention.
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Secondary outcome [5]
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Perspectives on body image as measured by the Ideal- Body Stereotype Scale-Revised – (IBSS-R; Stice et al., 2008).
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Assessment method [5]
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Timepoint [5]
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Baseline (pre-treatment), Post-treatment (post-conclusion of intervention), One-month follow-up post-conclusion of intervention.
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Secondary outcome [6]
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Depressive symptoms as measured by the Depression scale of the Depression, Anxiety and Stress Scale (DASS-21; Lovibond & Lovibond, 1995).
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Assessment method [6]
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Timepoint [6]
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Baseline (pre-treatment), Post-treatment (post-conclusion of intervention), One-month follow-up post-conclusion of intervention.
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Secondary outcome [7]
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Anxiety symptoms as measured by the Anxiety scale of the Depression, Anxiety and Stress Scale (DASS-21; Lovibond & Lovibond, 1995).
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Assessment method [7]
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Timepoint [7]
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Baseline (pre-treatment), Post-treatment (post-conclusion of intervention), One-month follow-up post-conclusion of intervention.
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Secondary outcome [8]
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Stress symptoms as measured by the Stress scale of the Depression, Anxiety and Stress Scale (DASS-21; Lovibond & Lovibond, 1995).
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Assessment method [8]
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Timepoint [8]
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Baseline (pre-treatment), Post-treatment (post-conclusion of intervention), One-month follow-up post-conclusion of intervention.
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Secondary outcome [9]
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Eating disorder related cognitions as measured by the Eating Disorder Core Beliefs Questionnaire - Revised (ED-CBQ-R; Hatoum, Burton, Abbott, 2022)
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Assessment method [9]
434887
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Timepoint [9]
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Secondary outcome [10]
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Eating disorder related cognitions as measured by the Eating Disorder Core Beliefs Questionnaire - Revised (ED-CBQ-R; Hatoum, Burton, Abbott, 2022)
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Assessment method [10]
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Timepoint [10]
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Baseline (pre-treatment), Post-treatment (post-conclusion of intervention), One-month follow-up post-conclusion of intervention.
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Eligibility
Key inclusion criteria
Participants must be young people seeking support from headspace Camperdown.
• Age range: 12-25 years.
• Willingness to give informed consent, and willingness to participate to and comply with the study.
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Minimum age
12
Years
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Maximum age
25
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
The following criteria will be applied but are also a pre-existing criteria for clients attending headspace Camperdown therefore any interested participants are very unlikely to be screened out based on the below criteria.
• Patients with a history of a psychological illness or condition such as to interfere with the patient's ability to understand the requirements of the study.
• Patients with a disease that is likely to interfere with the evaluation of the patient's safety and of the study outcome.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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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
Descriptive statistics will be gathered to analyze general sample characteristics and gain a broad understanding of the sample and population. To investigate the treatment outcomes (questionnaires of psychological distress, eating disorder symptomatology and body image related questionnaires) F-tests (two-way ANOVAS, repeated measures) will be conducted to investigate within group differences (pre, post, 1 month follow up) and between group differences (Body Project versus Control) and interaction effects.
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
24/07/2023
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Actual
20/11/2023
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Date of last participant enrolment
Anticipated
21/10/2024
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Actual
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Date of last data collection
Anticipated
16/12/2024
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Actual
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Sample size
Target
100
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Accrual to date
6
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment postcode(s) [1]
40572
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2050 - Camperdown
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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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The University of Technology Sydney
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Address [1]
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Graduate School of Health
Faculty of Health
100 Broadway
The University of Technology Sydney
Ultimo NSW 2007
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Country [1]
314081
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Australia
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Primary sponsor type
University
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Name
The University of Technology Sydney
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Address
Graduate School of Health
Faculty of Health
100 Broadway
The University of Technology Sydney
Ultimo NSW 2007
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Country
Australia
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Secondary sponsor category [1]
315990
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University
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Name [1]
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The University of Sydney
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Address [1]
315990
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headspace Camperdown
The Brain and Mind Centre
The University of Sydney
97 Church St Camperdown NSW 2050
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Country [1]
315990
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
315267
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UTS Health and Medical Research Ethics Committee
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Ethics committee address [1]
315267
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https://www.uts.edu.au/research-and-teaching/research/our-approach/ethics-and-integrity/human-research-ethics
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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22/06/2023
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Approval date [1]
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28/08/2023
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Ethics approval number [1]
315267
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ETH23-8405
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Summary
Brief summary
The current study aims to investigate the outcomes, benefits and feasibility of a brief evidence-based eating disorder prevention program within an Australian youth mental health service (at headspace Camperdown).
This program is the Body Project program, which is a well-established eating disorder (ED) prevention program. The study aims to investigate the feasibility of this program in a sample of young Australians (between ages 12-25). Specifically, this study aims to compare outcomes (including body image concerns/outcomes, eating disorder symptomatology and general psychological distress) between the those who complete the Body Project program at headspace (our Treatment Group) and those who do not complete the Body Project program but who do continue to access their standard care at headspace (Treatment-as-usual Control group), and compare outcomes pre-treatment, post-treatment and at one month follow-up.
By conducting this study we hope to assess the potential utility of such a brief and low-cost program within the headspace centre setting which, if found to be effective, could be rolled out nationally (to the 150+ headspace centres around Australia) as an early intervention approach to preventing the development of eating disorders amongst Australian youth.
We hypothesise that our study results will demonstrate that attending the Body Project group program embedded into the headspace youth mental health service model will effectively reduce symptoms of eating disorders, body image concerns and psychological distress for young Australians at risk of developing an eating disorder.
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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 Amy Burton
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Address
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Graduate School of Health
Faculty of Health
100 Broadway
University of Technology Sydney
Broadway NSW 2007
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Country
127386
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Australia
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Phone
127386
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+61 02 9514 1448
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Fax
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Email
127386
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[email protected]
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Contact person for public queries
Name
127387
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Dr Amy Burton
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Address
127387
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Graduate School of Health
Faculty of Health
100 Broadway
University of Technology Sydney
Broadway NSW 2007
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Country
127387
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Australia
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Phone
127387
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+61 02 9514 1448
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Fax
127387
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Email
127387
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[email protected]
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Contact person for scientific queries
Name
127388
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Dr Amy Burton
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Address
127388
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Graduate School of Health
Faculty of Health
100 Broadway
University of Technology Sydney
Broadway NSW 2007
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Country
127388
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Australia
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Phone
127388
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+61 02 9514 1448
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Fax
127388
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Email
127388
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
De-identified individual participant data collected throughout the study.
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When will data be available (start and end dates)?
Following publication of the study results, no end date.
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Available to whom?
Available to those who request it
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Available for what types of analyses?
Any purpose
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How or where can data be obtained?
Access subject to approvals by Principal Investigator (
[email protected]
)
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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