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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
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
Secondary ID [1] 309953 0
None
Universal Trial Number (UTN)
U1111-1293-8206
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
eating disorder 330359 0
body image concerns 330360 0
psychological distress 330361 0
Condition category
Condition code
Mental Health 327205 327205 0 0
Eating disorders

Intervention/exposure
Study type
Interventional
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).
Intervention code [1] 326336 0
Prevention
Intervention code [2] 326373 0
Treatment: Other
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.
Control group
Active

Outcomes
Primary outcome [1] 335097 0
Eating disorder symptom severity as measured by the Eating Disorder Examination Questionnaire - Short (EDE-QS; Gideon et al., 2016)
Timepoint [1] 335097 0
Baseline (pre-treatment), Post-treatment (post-conclusion of intervention), One-month follow-up post-conclusion of intervention.
Primary outcome [2] 335098 0
Eating disorder symptom severity as measured by the Inside Out Screener (Bryant et al., 2021).
Timepoint [2] 335098 0
Baseline (pre-treatment), Post-treatment (post-conclusion of intervention), One-month follow-up post-conclusion of intervention.
Secondary outcome [1] 422986 0
Perspectives on body image as measured by the Perceived Socio-cultural Pressure Scale (PSPS; Stice & Bearman, 2001)
Timepoint [1] 422986 0
Baseline (pre-treatment), Post-treatment (post-conclusion of intervention), One-month follow-up post-conclusion of intervention.
Secondary outcome [2] 422987 0
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).
Timepoint [2] 422987 0
Baseline (pre-treatment), Post-treatment (post-conclusion of intervention), One-month follow-up post-conclusion of intervention.
Secondary outcome [3] 423317 0
Psychological distress as measured by the Kessler Psychological Distress Scale (K10; Kessler et al., 2003)
Timepoint [3] 423317 0
Baseline (pre-treatment), Post-treatment (post-conclusion of intervention), One-month follow-up post-conclusion of intervention.
Secondary outcome [4] 423318 0
Positive self-body image as measured by the Body Appreciation Scale -2 (BAS-2; Tylka & Wood-Barcalow, 2015)
Timepoint [4] 423318 0
Baseline (pre-treatment), Post-treatment (post-conclusion of intervention), One-month follow-up post-conclusion of intervention.
Secondary outcome [5] 423319 0
Perspectives on body image as measured by the Ideal- Body Stereotype Scale-Revised – (IBSS-R; Stice et al., 2008).
Timepoint [5] 423319 0
Baseline (pre-treatment), Post-treatment (post-conclusion of intervention), One-month follow-up post-conclusion of intervention.
Secondary outcome [6] 423509 0
Depressive symptoms as measured by the Depression scale of the Depression, Anxiety and Stress Scale (DASS-21; Lovibond & Lovibond, 1995).
Timepoint [6] 423509 0
Baseline (pre-treatment), Post-treatment (post-conclusion of intervention), One-month follow-up post-conclusion of intervention.
Secondary outcome [7] 423510 0
Anxiety symptoms as measured by the Anxiety scale of the Depression, Anxiety and Stress Scale (DASS-21; Lovibond & Lovibond, 1995).
Timepoint [7] 423510 0
Baseline (pre-treatment), Post-treatment (post-conclusion of intervention), One-month follow-up post-conclusion of intervention.
Secondary outcome [8] 423511 0
Stress symptoms as measured by the Stress scale of the Depression, Anxiety and Stress Scale (DASS-21; Lovibond & Lovibond, 1995).
Timepoint [8] 423511 0
Baseline (pre-treatment), Post-treatment (post-conclusion of intervention), One-month follow-up post-conclusion of intervention.
Secondary outcome [9] 434887 0
Eating disorder related cognitions as measured by the Eating Disorder Core Beliefs Questionnaire - Revised (ED-CBQ-R; Hatoum, Burton, Abbott, 2022)
Timepoint [9] 434887 0
Secondary outcome [10] 434888 0
Eating disorder related cognitions as measured by the Eating Disorder Core Beliefs Questionnaire - Revised (ED-CBQ-R; Hatoum, Burton, Abbott, 2022)
Timepoint [10] 434888 0
Baseline (pre-treatment), Post-treatment (post-conclusion of intervention), One-month follow-up post-conclusion of intervention.

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.
Minimum age
12 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
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.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
24/07/2023
Actual
20/11/2023
Date of last participant enrolment
Anticipated
21/10/2024
Actual
Date of last data collection
Anticipated
16/12/2024
Actual
Sample size
Target
100
Accrual to date
6
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 40572 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 314081 0
University
Name [1] 314081 0
The University of Technology Sydney
Country [1] 314081 0
Australia
Primary sponsor type
University
Name
The University of Technology Sydney
Address
Graduate School of Health
Faculty of Health
100 Broadway
The University of Technology Sydney
Ultimo NSW 2007
Country
Australia
Secondary sponsor category [1] 315990 0
University
Name [1] 315990 0
The University of Sydney
Address [1] 315990 0
headspace Camperdown
The Brain and Mind Centre
The University of Sydney
97 Church St Camperdown NSW 2050
Country [1] 315990 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315267 0
UTS Health and Medical Research Ethics Committee
Ethics committee address [1] 315267 0
Ethics committee country [1] 315267 0
Australia
Date submitted for ethics approval [1] 315267 0
22/06/2023
Approval date [1] 315267 0
28/08/2023
Ethics approval number [1] 315267 0
ETH23-8405

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 127386 0
Dr Amy Burton
Address 127386 0
Graduate School of Health
Faculty of Health
100 Broadway
University of Technology Sydney
Broadway NSW 2007
Country 127386 0
Australia
Phone 127386 0
+61 02 9514 1448
Fax 127386 0
Email 127386 0
[email protected]
Contact person for public queries
Name 127387 0
Amy Burton
Address 127387 0
Graduate School of Health
Faculty of Health
100 Broadway
University of Technology Sydney
Broadway NSW 2007
Country 127387 0
Australia
Phone 127387 0
+61 02 9514 1448
Fax 127387 0
Email 127387 0
[email protected]
Contact person for scientific queries
Name 127388 0
Amy Burton
Address 127388 0
Graduate School of Health
Faculty of Health
100 Broadway
University of Technology Sydney
Broadway NSW 2007
Country 127388 0
Australia
Phone 127388 0
+61 02 9514 1448
Fax 127388 0
Email 127388 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified individual participant data collected throughout the study.
When will data be available (start and end dates)?
Following publication of the study results, no end date.
Available to whom?
Available to those who request it
Available for what types of analyses?
Any purpose
How or where can data be obtained?
Access subject to approvals by Principal Investigator ([email protected])


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.