Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000274279
Ethics application status
Approved
Date submitted
16/02/2018
Date registered
22/02/2018
Date last updated
8/08/2019
Date data sharing statement initially provided
29/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A visual training program for body dysmorphic disorder: A novel intervention trial
Scientific title
A visual training program to remediate perceptual abnormalities in body dysmorphic disorder: A novel intervention trial
Secondary ID [1] 294075 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Body dysmorphic disorder 306632 0
Condition category
Condition code
Mental Health 305735 305735 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Visual training program for body dysmorphic disorder: A novel intervention trial
Up to 20 participants diagnosed with body dysmorphic disorder (BDD) will be recruited to participate in a visual training program. The visual training program will involve three phases presented in a bottom up sequence, consisting of 1) basic visual processing, 2) face specific visual processing, and 3) self-perception. Phases 1 and 2 will be administered using computer tasks from Posit Science (Brain HQ), and phase 3 involves 'perceptual mirror retraining' activities drawn from the Cognitive-Behavioral Therapy for Body Dysmorphic Disorder manual (Phillips, Wilhelm & Steketee, 2012).
Phase 1 will be delivered during weeks 1-4 using the Posit Science computer training module. This phase will be administered in a one-on-one face-to-face consultation between the therapist and participant, where the therapist will provide instructions and answer any questions. Adherence will be monitored using feedback from posit science.
Phase 2 will be delivered during weeks 5-8 using the Posit Science computer training module. This phase will be administered in a one-on-one face-to-face consultation between the therapist and participant, where the therapist will provide instructions and answer any questions. Adherence will be monitored using feedback from posit science.
Phase 3 will be delivered during weeks 9 and 10 using perceptual mirror retraining principles. This phase will be administered in a one-on-one face-to-face consultation between the therapist and participant, where the therapist will instruct, and guide the participant through the exercise and answer any questions.
This visual training program will be presented over a series of 10 weekly sessions, with each session running for one to two hours, resulting in a total of 16.8 hours in line with recommendations from Posit Science. Participants will complete a comprehensive pre- and post-assessment, including a range of self-report questionnaires, clinical interview measures, and a full eye-tracking battery. Between each phase, participants will also complete a brief assessment to track for any change throughout the program, including a brief symptom severity measure and eye tracking task. This program will be conducted by a provisional psychologist who has received specialised training in BDD in both clinical and research-specific contexts. The provisional psychologist will be blind to all assessment results. This training program will be administered face-to-face at Swinburne University of Technology, Melbourne, Australia.
Intervention code [1] 300344 0
Treatment: Other
Intervention code [2] 300345 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 304808 0
Change in 'Body dysmorphic disorder modification of the Yale Brown Obsessive Compulsive Scale' (BDD-YBOCS) scores
Timepoint [1] 304808 0
Baseline and at 7 days post completion of intervention
Primary outcome [2] 304809 0
Changes in patterns of eye movements will be assessed using an eye tracking device
Timepoint [2] 304809 0
Baseline and at 7 days post complintervention
Primary outcome [3] 304810 0
Change in diagnostic criteria met as qualified by the Mini International Neuropsychiatric Interview (MINI), including the Body Dysmorphic Disorder Module (BDDM)
Timepoint [3] 304810 0
Baseline and at 7 days post completion of intervention
Secondary outcome [1] 343262 0
Change in 'Dysmorphic concern questionnaire' (DCQ) scores
Timepoint [1] 343262 0
Baseline (prior to commencement of treatment), weeks 4, 8, 10, and 7 days post intervention
Secondary outcome [2] 343263 0
Change in the 'memory-guided' task assessed using an eye tracking machine. In this task, participants will be asked to fixate on a cross in the centre of the screen whilst another stimulus is presented in the periphery. The stimulus will disappear after a short period and then the participant will be required to look at (make a saccade towards) where they recall the stimulus in the periphery to have appeared. Performance on this task is assessed by inhibitory error rate and eye movement parameters.
Timepoint [2] 343263 0
Baseline (prior to commencement of treatment), weeks 4, 8, 10, and 7 days post intervention
Secondary outcome [3] 343264 0
Change in 'Depression Anxiety Stress Scales' (DASS-21) scores
Timepoint [3] 343264 0
Baseline and at 7 days post completion of the intervention
Secondary outcome [4] 343265 0
Change in 'Social Interaction Anxiety Scale' (SIAS) scores
Timepoint [4] 343265 0
Baseline and at 7 days post completion of the intervention
Secondary outcome [5] 343266 0
Change in 'Body Appreciate Scale' (BAS 2) scores
Timepoint [5] 343266 0
Baseline and at 7 days post completion of the intervention
Secondary outcome [6] 343267 0
Changes in 'Mirror gazing: cognition and affect rating scale' (MG-CARS) scores
Timepoint [6] 343267 0
Baseline and at 7 days post completion of the intervention
Secondary outcome [7] 343268 0
Changes in 'Assessment of Quality of Life' (AQoL) scores
Timepoint [7] 343268 0
Baseline and at 7 days post completion of the intervention

Eligibility
Key inclusion criteria
1. between the ages of 18 to 65 years old
2. have a primary diagnosis of BDD
3. have a preferred language of English
4. are available to attend 10 weekly treatment sessions at Swinburne University, Melbourne, Australia
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. unable to provide informed consent
2. history of neurological or eye conditions
3. lifetime diagnosis of anorexia nervosa, bulimia nervosa, substance dependence disorder, or a psychotic disorder

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Due to the innovative and novel aspects of this visual training program to be used in BDD, a single-group open label trial will be conducted. As this will be an exploratory study of the effectiveness and feasibility of the visual training program, sample size calculations were not conducted.
Repeated measures analysis of variance (ANOVA) will be conducted to compare performance on the measures used within the change tracking assessments, including the brief eye tracking measure and the DCQ. This will assess the impact each phase has upon last, by examining the participants’ eye movements and symptom severity. A one-way analysis of variance will also be performed to compare results from the pre- and post-assessments (clinical interview, self-report questionnaires and battery of eye tracking tasks), to determine the overall impact of the 10-week visual training program.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
12/03/2018
Actual
13/04/2018
Date of last participant enrolment
Anticipated
11/02/2019
Actual
30/01/2019
Date of last data collection
Anticipated
30/04/2019
Actual
15/03/2019
Sample size
Target
20
Accrual to date
Final
11
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 21562 0
3122 - Hawthorn

Funding & Sponsors
Funding source category [1] 298704 0
Government body
Name [1] 298704 0
Australian Government Research Training Program Scholarship
Country [1] 298704 0
Australia
Primary sponsor type
University
Name
Swinburne University of Technology
Address
John St Hawthorn VIC 3122
Country
Australia
Secondary sponsor category [1] 297873 0
None
Name [1] 297873 0
Address [1] 297873 0
Country [1] 297873 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299653 0
Swinburne University Human Research Ethics Committee (SUHREC)
Ethics committee address [1] 299653 0
Ethics committee country [1] 299653 0
Australia
Date submitted for ethics approval [1] 299653 0
23/11/2017
Approval date [1] 299653 0
18/12/2017
Ethics approval number [1] 299653 0
SUHREC 2017/333

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

Contacts
Principal investigator
Name 81182 0
Prof Susan Rossell
Address 81182 0
ATC916, Centre for Mental Health, Swinburne University of Technology, John Street, Hawthorn VIC 3211
Country 81182 0
Australia
Phone 81182 0
+61 3 9214 8173
Fax 81182 0
Email 81182 0
[email protected]
Contact person for public queries
Name 81183 0
Francesca Beilharz
Address 81183 0
400B, Centre for Mental Health, Swinburne University of Technology, John Street, Hawthorn VIC 3211
Country 81183 0
Australia
Phone 81183 0
+61 3 9214 5614
Fax 81183 0
Email 81183 0
[email protected]
Contact person for scientific queries
Name 81184 0
Francesca Beilharz
Address 81184 0
400B, Centre for Mental Health, Swinburne University of Technology, John Street, Hawthorn VIC 3211
Country 81184 0
Australia
Phone 81184 0
+61 3 9214 5614
Fax 81184 0
Email 81184 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Only group results will be available, as within the consent form


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
1199Study protocol    https://doi.org/10.1186/s40814-018-0384-3



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseVisual training program for body dysmorphic disorder: Protocol for a novel intervention pilot and feasibility trial.2018https://dx.doi.org/10.1186/s40814-018-0384-3
N.B. These documents automatically identified may not have been verified by the study sponsor.