ANZCTR - Registration

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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]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Body dysmorphic disorder

Condition category

Condition code

Mental Health

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]

Behaviour

Intervention code [2]

Treatment: Other

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Body dysmorphic disorder symptom severity (BDD-YBOCS)

Timepoint [1]

1-week post treatment (primary time point), 2-months post treatment

Primary outcome [2]

BDD diagnostic status (BDD Diagnostic Module)

Timepoint [2]

1-week post-treatment (primary time point), 2 months post-treatment

Secondary outcome [1]

Anxiety (Spence Children's Anxiety Scale - Parent and Child Report)

Timepoint [1]

1-week post-treatment, 2 months post-treatment

Secondary outcome [2]

Depression (Short Mood and Feelings Questionnaire - Parent and Child report)

Timepoint [2]

1-week post-treatment, 2 months post-treatment

Secondary outcome [3]

Parent-reported executive function (Behavior Rating Inventory of Executive Function [BRIEF] - Parent report)

Timepoint [3]

1-week post-treatment, 2 months post-treatment

Secondary outcome [4]

Family accommodation (parent-report Family Accomodation Scale - Anxiety [FASA-A])

Timepoint [4]

1-week post-treatment, 2 months post-treatment

Secondary outcome [5]

Perceived peer victimisation (Perceptions of Teasing Scale - POTS)

Timepoint [5]

1-week post-treatment, 2 months post-treatment

Secondary outcome [6]

Perceived social support (Child and Adolescent Social Support Scale - CASSS)

Timepoint [6]

1-week post-treatment, 2-months post treatment

Secondary outcome [7]

Co-rumination about appearance with peers (Co-Rumination about Appearance Scale)

Timepoint [7]

1-week post-treatment, 2 months post-treatment

Secondary outcome [8]

Self-report body dysmorphic symptoms - Appearance Anxiety Inventory (AAI)

Timepoint [8]

1-week post-treatment, 2 months post-treatment

Secondary outcome [9]

Disorder-Related Insight - Brown Assessment of Beliefs Scale (BABS)

Timepoint [9]

1-week post-treatment, 2 months post-treatment

Secondary outcome [10]

Comorbidity - Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-Kid)

Timepoint [10]

1-week post-treatment, 2 months post-treatment

Secondary outcome [11]

Global Severity - Clinical Global Impression Scale (CGI)

Timepoint [11]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors

Funding source category [1]

University

Name [1]

Macquarie University, Higher Degree Research Fund

Address [1]

Macquarie University, Macquarie Park, NSW 2109, Australia

Country [1]

Australia

Primary sponsor type

Individual

Name

Ron Rapee, Distinguished Professor

Address

Macquarie University, Macquarie Park, NSW 2109, Australia

Country

Australia

Secondary sponsor category [1]

Individual

Name [1]

Cassie Lavell, PhD Candidate

Address [1]

Macquarie University, Macquarie Park, NSW 2109, Australia

Country [1]

Australia

Secondary sponsor category [2]

Individual

Name [2]

Ella Oar, Postdoctoral Research Fellow & Clinical Psychologist

Address [2]

Macquarie University, Macquarie Park, NSW 2109, Australia

Country [2]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Macquarie University Human Research Ethics Committee Medical Sciences

Ethics committee address [1]

Macquarie University, Macquarie Park, NSW 2109, Australia

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

08/04/2021

Approval date [1]

21/06/2021

Ethics approval number [1]

52021948928846

Summary

Brief summary

This study aims to evaluate the effectiveness of a new online treatment for body dysmorphic disorder (BDD) in adolescents. BDD is an underrecognised and undertreated mental health condition, characterised by a preoccupation with perceived flaws in physical appearance. There is a paucity of research exploring the disorder among youth. In adults with BDD, cognitive-behavioural therapy (CBT) has been shown to be an effective treatment. There is some evidence that CBT can be effective for some youth with BDD, however many young people remain impaired by their BDD following treatment. Therefore, this study aims to test a developmentally-tailored CBT approach to treating adolescent BDD. The therapy will be delivered via videoconference to families, to increase accessibility to the study.

Trial website

https://www.mq.edu.au/research/research-centres-groups-and-facilities/healthy-people/centres/centre-for-emotional-health-ceh/our-projects/body-dysmorphic-disorder-in-adolescents

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Ron Rapee

Address

Macquarie University, Macquarie Park, NSW 2109, Australia

Country

Australia

Phone

+61 2 9850 8032

Fax

[email protected]

Contact person for public queries

Name

Cassie Lavell

Address

Macquarie University, Macquarie Park, NSW 2109, Australia

Country

Australia

Phone

+61 432611172

Fax

[email protected]

Contact person for scientific queries

Name

Cassie Lavell

Address

Macquarie University, Macquarie Park, NSW 2109, Australia

Country

Australia

Phone

+61 432611172

Fax

[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?

What supporting documents are/will be available?

Doc. No.	Type	Other Details	Attachment
14703	Ethical approval		Study-related document.pdf
14704	Study protocol	Study assessment protocol	Study-related document.docx
14705	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.

Trial Review

Documents added manually

Documents added automatically