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Trial registered on ANZCTR


Registration number
ACTRN12622000945729
Ethics application status
Approved
Date submitted
29/06/2022
Date registered
5/07/2022
Date last updated
3/02/2023
Date data sharing statement initially provided
5/07/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating a Group Cognitive Behavioural Therapy Program for Adults with Muscle Dysmorphia
Scientific title
Evaluation of a Pilot Online Group Cognitive Behavioural Therapy (CBT) Program for Muscle Dysmorphia Symptoms in Adults with Muscle Dysmorphia
Secondary ID [1] 307456 0
X22-0147
Universal Trial Number (UTN)
N/A
Trial acronym
N/A
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Muscle Dysmorphia 326837 0
Condition category
Condition code
Mental Health 324048 324048 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This intervention is a pilot online 8-week group cognitive behavioural therapy (CBT) program for adults with muscle dysmorphia living in Australia. To date, no treatment studies have been conducted in muscle dysmorphia.

The CBT program will be delivered online in a group format using Zoom with 8 90-minute weekly sessions. There is no control group for this pilot study, so it is a single-arm trial. We are aiming to recruit 8-14 participants who will be split across two treatment groups. Session attendance checklists will be used to monitor adherence to the intervention.

The initial template for the program came from the Individual Intensive Outpatient Program and Overcoming Binge Eating groups run by the Peter Beumont Eating Disorders Non-Admitted Service at RPA Hospital, which are 8- and 10-week, respectively, structured group programs for outpatients with an eating disorder. Both programs are standardised and have been running at RPA Hospital for at least the past decade. Both programs are grounded in principles of CBT and have been modified in this study for the treatment of muscle dysmorphia.

The program will be facilitated by a PhD student and registered general psychologist. The study facilitator will receive weekly clinical supervision from a registered clinical psychologist throughout the 8-week program.

A brief summary of the content to be covered in each weekly session is outlined below:

1 - Introduction
• Group orientation
• Introduction to CBT
• Setting SMART goals
• Introduction to CBT formulation of muscle dysmorphia

2 – Addressing strict dieting and establishing flexible eating
• Dieting and restrictive eating
• Calorie/protein tracking
• Behavioural experiment to address food avoidance and/or challenge dietary rules

3 – Addressing compulsive exercise
• Healthy vs. unhealthy exercise
• Compulsive exercise
• Exposure and response prevention to challenge compulsive exercise

4 – Developing alternate emotion regulation strategies
• Mood intolerance
• Developing alternate emotion regulation strategies to diet/exercise

5 – Building up marginalised areas of life
• Overvaluation of weight/shape
• Identifying overvalued/marginalised areas of life (pie chart exercise)
• Overvaluation of control of weight/shape

6 – Addressing checking and avoidance behaviours
• Body image
• Checking behaviours and response prevention
• Avoidance behaviours and graded exposure hierarchy

7 – Addressing feeling small/skinny and comparison making
• Feeling small or skinny
• Cognitive reappraisal of feeling small
• Comparison making and associated biases
• Behavioural experiment(s) to address comparison making

8 – Relapse prevention planning
• Realistic expectations of recovery
• Dealing with relapse and setbacks
• Relapse prevention planning
Intervention code [1] 323909 0
Treatment: Other
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 331837 0
Change in mean muscle dysmorphia symptomology assessed using the Muscle Dysmorphia Inventory (MDI)
Timepoint [1] 331837 0
Pre-intervention, post-intervention (primary endpoint), and 3-month follow-up post-intervention
Primary outcome [2] 331865 0
Change in mean muscle dysmorphia symptomology assessed using the Muscle Dysmorphic Disorder Inventory (MDDI)
Timepoint [2] 331865 0
Pre-intervention, post-intervention (primary endpoint), and 3-month follow-up post-intervention.
Primary outcome [3] 331866 0
Change in mean muscle dysmorphia symptomology assessed using the Muscle Appearance Satisfaction Scale (MASS)
Timepoint [3] 331866 0
Pre-intervention, post-intervention (primary endpoint), and 3-month follow-up post-intervention
Secondary outcome [1] 411345 0
Changes in mean compulsive exercise scores (Compulsive Exercise Test)
Timepoint [1] 411345 0
Pre-intervention, post-intervention, and 3-month follow-up post-intervention
Secondary outcome [2] 411418 0
Changes in mean disordered eating scores (Eating Pathology Symptoms Inventory)
Timepoint [2] 411418 0
Pre-intervention, post-intervention, and 3-month follow-up post-intervention
Secondary outcome [3] 411419 0
Changes in mean depression scores (PHQ-9)
Timepoint [3] 411419 0
Pre- to post-intervention
Secondary outcome [4] 411420 0
Changes in mean psychological distress scores (K-10)
Timepoint [4] 411420 0
Pre- to post-intervention

Eligibility
Key inclusion criteria
• Age greater than or equal to 18 years.
• Currently living in Australia.
• Self-report that they think about not being big enough at least once per day (assessed on a pre-screening webpage).
• Meet diagnostic criteria for MD (based on both DSM-5 and Pope et al., 1997 criteria) – assessed via a clinical diagnostic interview.
• Receive a letter of medical clearance from their GP – includes blood test assessment.
• Willingness to provide informed consent and attend the entire 8-week treatment program.
• Access to a private space with sufficiently technology to engage in telehealth sessions (i.e., laptop or phone with video camera and stable internet connection).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Non-proficient English speaker.
• Presence of significant medical instability (i.e., GP unable to provide a letter of medical clearance).
• Active suicidality, or self-harm behaviours, or meeting clinical threshold for suicide risk – assessed via the clinical diagnostic interview and the Suicide Behaviors Questionnaire-Revised (SBQ-R) where a score greater than or equal to 7 indicates notable suicide risk in the general population.
• Comorbid Major Depressive Disorder (MDD) – assessed via Patient Health Questionnaire-9 (PHQ-9) where a score greater than or equal to 10 indicates clinical depression that warrants treatment and could interfere with participation in the treatment program.
• Prescribed a new psychotropic medication (e.g., SSRIs) in the past month or expects to be prescribed a new psychotropic medication at any point throughout the 8-week treatment program.
• Currently involved in other active psychological treatment or plans to engage in other active psychological treatment over the course of the 8-week treatment program.

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)
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
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
We will use quantitative methods to analyse data collected for this pilot treatment study. The main outcome of interest is changes in MD symptomology across the three assessment periods: pre-intervention, post-intervention, and follow-up. Changes in MD symptomology will be assessed using Generalized Linear Mixed Models (GLMM). GLMM will also be used to assess the extent to which changes in compulsive exercise and disordered eating are associated with changes in MD symptomology.

Process issues that emerged when conducting the group treatment program will be discussed in the manuscript but will not be analysed using formal methods. Discussions will focus on the lead investigator’s subjective experience of running the group program as well as reflections on which aspects of the CBT-E program resonated most/least with participants.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
9/01/2023
Actual
Date of last participant enrolment
Anticipated
3/02/2023
Actual
Date of last data collection
Anticipated
13/07/2023
Actual
Sample size
Target
14
Accrual to date
0
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 311727 0
Other Collaborative groups
Name [1] 311727 0
InsideOut Institute for Eating Disorders
Country [1] 311727 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
The University of Sydney, City Road, Camperdown/Darlington, NSW Sydney 2006
Country
Australia
Secondary sponsor category [1] 313187 0
None
Name [1] 313187 0
Address [1] 313187 0
Country [1] 313187 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311175 0
Ethics Review Committee (RPAH Zone) of the Sydney Local Health District
Ethics committee address [1] 311175 0
Ethics committee country [1] 311175 0
Australia
Date submitted for ethics approval [1] 311175 0
24/05/2022
Approval date [1] 311175 0
11/07/2022
Ethics approval number [1] 311175 0

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

Contacts
Principal investigator
Name 120218 0
A/Prof Sarah Maguire
Address 120218 0
InsideOut Institute for Eating Disorders, Level 2, The Charles Perkins Centre, D17, John Hopkins Drive, Camperdown, Sydney NSW 2006
Country 120218 0
Australia
Phone 120218 0
+61 2 86275690
Fax 120218 0
Email 120218 0
sarah.maguire@sydney.edu.au
Contact person for public queries
Name 120219 0
Jordan Martenstyn
Address 120219 0
InsideOut Institute for Eating Disorders, Level 2, The Charles Perkins Centre, D17, John Hopkins Drive, Camperdown, Sydney NSW 2006
Country 120219 0
Australia
Phone 120219 0
+61 431503270
Fax 120219 0
Email 120219 0
jmar5023@uni.sydney.edu.au
Contact person for scientific queries
Name 120220 0
Jordan Martenstyn
Address 120220 0
InsideOut Institute for Eating Disorders, Level 2, The Charles Perkins Centre, D17, John Hopkins Drive, Camperdown, Sydney NSW 2006
Country 120220 0
Australia
Phone 120220 0
+61 431503270
Fax 120220 0
Email 120220 0
jmar5023@uni.sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We are interested in changes in group means and to protect client confidentiality.


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.