Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000409774
Ethics application status
Approved
Date submitted
7/02/2022
Date registered
9/03/2022
Date last updated
17/11/2024
Date data sharing statement initially provided
9/03/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Cognitive-behavioural therapy for adolescent body dysmorphic disorder
Scientific title
The efficacy of cognitive-behavioural therapy for adolescent body dysmorphic disorder
Secondary ID [1] 305515 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Body dysmorphic disorder 323906 0
Condition category
Condition code
Mental Health 321422 321422 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
12 weekly, 90-minute cognitive behavioural therapy (CBT) sessions will be delivered via videoconference (Zoom). The intervention will be delivered by a registered clinical psychologist (Cassie Lavell, PhD candidate). All sessions require attendance by the adolescent and at least one parent/caregiver. CBT sessions will involve psycho-education about body dysmorphic disorder (BDD), cognitive restructuring, attention training, addressing family accommodation, social skill building, exposure with response prevention (ERP), and relapse prevention.
Intervention code [1] 321918 0
Behaviour
Intervention code [2] 322852 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 329197 0
Body dysmorphic disorder symptom severity (BDD-YBOCS)
Timepoint [1] 329197 0
1-week post treatment (primary time point), 2-months post treatment
Primary outcome [2] 329198 0
BDD diagnostic status (BDD Diagnostic Module)
Timepoint [2] 329198 0
1-week post-treatment (primary time point), 2 months post-treatment
Secondary outcome [1] 401748 0
Anxiety (Spence Children's Anxiety Scale - Parent and Child Report)
Timepoint [1] 401748 0
1-week post-treatment, 2 months post-treatment
Secondary outcome [2] 401749 0
Depression (Short Mood and Feelings Questionnaire - Parent and Child report)
Timepoint [2] 401749 0
1-week post-treatment, 2 months post-treatment
Secondary outcome [3] 401750 0
Parent-reported executive function (Behavior Rating Inventory of Executive Function [BRIEF] - Parent report)
Timepoint [3] 401750 0
1-week post-treatment, 2 months post-treatment
Secondary outcome [4] 401751 0
Family accommodation (parent-report Family Accomodation Scale - Anxiety [FASA-A])
Timepoint [4] 401751 0
1-week post-treatment, 2 months post-treatment
Secondary outcome [5] 401752 0
Perceived peer victimisation (Perceptions of Teasing Scale - POTS)
Timepoint [5] 401752 0
1-week post-treatment, 2 months post-treatment
Secondary outcome [6] 406937 0
Perceived social support (Child and Adolescent Social Support Scale - CASSS)
Timepoint [6] 406937 0
1-week post-treatment, 2-months post treatment
Secondary outcome [7] 406938 0
Co-rumination about appearance with peers (Co-Rumination about Appearance Scale)
Timepoint [7] 406938 0
1-week post-treatment, 2 months post-treatment
Secondary outcome [8] 407155 0
Self-report body dysmorphic symptoms - Appearance Anxiety Inventory (AAI)
Timepoint [8] 407155 0
1-week post-treatment, 2 months post-treatment
Secondary outcome [9] 407156 0
Disorder-Related Insight - Brown Assessment of Beliefs Scale (BABS)
Timepoint [9] 407156 0
1-week post-treatment, 2 months post-treatment
Secondary outcome [10] 407157 0
Comorbidity - Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-Kid)
Timepoint [10] 407157 0
1-week post-treatment, 2 months post-treatment
Secondary outcome [11] 407158 0
Global Severity - Clinical Global Impression Scale (CGI)
Timepoint [11] 407158 0
1-week post-treatment, 2 months post-treatment

Eligibility
Key inclusion criteria
1. Adolescents 12-17 years
2. Have a primary diagnosis of body dysmorphic disorder (BDD)
3. English preferred language
4. At least one parent available to attend all assessment and treatment appointments
Minimum age
12 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Intellectual Disability
2. Current risk of harm (e.g., active suicidal ideation, current abuse/neglect, unmanaged psychotic symptoms)
3. Body image concerns better accounted for by a current eating disorder e.g., anorexia nervosa, bulimia nervosa
4. Concurrent psychological therapy
5. Not on a stable dose of psycho-pharmacological medication (i.e., stable for 8 weeks prior to assessment and intent to stay on same dose)

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



Intervention assignment
Single group
Other design features
Single-subject, multiple baseline design. Participants will be randomised to 1, 2 or 3 weeks baseline period.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A series of repeated measures ANOVAs will be conducted followed by component pairwise comparisons, to examine participant changes over time on the primary and secondary outcomes. A Reliable Change Index (RCI; Jacobson & Truax, 1991) will be calculated to determine whether the magnitude of change in children's BDD severity (BDD-YBOCS) is clinically significant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
17/08/2021
Date of last participant enrolment
Anticipated
1/08/2022
Actual
5/12/2022
Date of last data collection
Anticipated
24/05/2023
Actual
30/06/2023
Sample size
Target
12
Accrual to date
Final
9
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 309790 0
University
Name [1] 309790 0
Macquarie University, Higher Degree Research Fund
Country [1] 309790 0
Australia
Primary sponsor type
Individual
Name
Ron Rapee, Distinguished Professor
Address
Macquarie University, Macquarie Park, NSW 2109, Australia
Country
Australia
Secondary sponsor category [1] 311769 0
Individual
Name [1] 311769 0
Cassie Lavell, PhD Candidate
Address [1] 311769 0
Macquarie University, Macquarie Park, NSW 2109, Australia
Country [1] 311769 0
Australia
Secondary sponsor category [2] 311937 0
Individual
Name [2] 311937 0
Ella Oar, Postdoctoral Research Fellow & Clinical Psychologist
Address [2] 311937 0
Macquarie University, Macquarie Park, NSW 2109, Australia
Country [2] 311937 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309541 0
Macquarie University Human Research Ethics Committee Medical Sciences
Ethics committee address [1] 309541 0
Ethics committee country [1] 309541 0
Australia
Date submitted for ethics approval [1] 309541 0
08/04/2021
Approval date [1] 309541 0
21/06/2021
Ethics approval number [1] 309541 0
52021948928846

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

Contacts
Principal investigator
Name 114518 0
Prof Ron Rapee
Address 114518 0
Macquarie University, Macquarie Park, NSW 2109, Australia
Country 114518 0
Australia
Phone 114518 0
+61 2 9850 8032
Fax 114518 0
Email 114518 0
[email protected]
Contact person for public queries
Name 114519 0
Cassie Lavell
Address 114519 0
Macquarie University, Macquarie Park, NSW 2109, Australia
Country 114519 0
Australia
Phone 114519 0
+61 432611172
Fax 114519 0
Email 114519 0
[email protected]
Contact person for scientific queries
Name 114520 0
Cassie Lavell
Address 114520 0
Macquarie University, Macquarie Park, NSW 2109, Australia
Country 114520 0
Australia
Phone 114520 0
+61 432611172
Fax 114520 0
Email 114520 0
[email protected]

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:
• Case-by-case basis at the discretion of the primary investigator

Conditions for requesting access:
• -

What individual participant data might be shared?
• De-identified individual participant data underlying published results only

What types of analyses could be done with individual participant data?
• for IPD meta-analyses

When can requests for individual participant data be made (start and end dates)?
From:
Feb 2023

To:
no end date.

Where can requests to access individual participant data be made, or data be obtained directly?
• Access subject to approvals by research team (Contact person: Cassie Lavell - [email protected])

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Ethical approval    Study-related document.pdf
Study protocol    Study assessment protocol Study-related document.docx
Informed consent form    Study-related document.pdf


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.