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Trial registered on ANZCTR


Registration number
ACTRN12614000894695
Ethics application status
Approved
Date submitted
7/08/2014
Date registered
22/08/2014
Date last updated
22/08/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Randomised Controlled Trial for the Efficacy of Treating Binge Eating Disorder with Eye Movement Desensitization Reprocessing
Scientific title
A Randomized Controlled Trial of Treating Binge Eating Disorder (B.E.D.) with Eye Movement Desensitization Reprocessing (EMDR)
Secondary ID [1] 285150 0
Nil known
Universal Trial Number (UTN)
U-01111-1160-6069
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Binge Eating Disorder 292681 0
Obesity 292682 0
Condition category
Condition code
Mental Health 292996 292996 0 0
Eating disorders
Diet and Nutrition 292997 292997 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A psychological treatment method Eye Movement Desensitization Reprocessing, usually used in the treatment of trauma, is used in a modified manner to target binge eating, comorbid mental health symptoms (e.g. depression, anxiety), self-esteem, body image, exercise motivation and weight. It will be used in ten 55-minute sessions one week apart by trained, qualified and experienced, registered psychologists in one-on-one sessions. They are required to pay $10 per session. Sessions will be audio-taped. Participants will be given pre- and post-treatment questionnaires to assess changes.
Intervention code [1] 289974 0
Treatment: Other
Intervention code [2] 290067 0
Behaviour
Comparator / control treatment
Wait-list control/no treatment group will be offered treatment after the wait period of 10 weeks.
Control group
Active

Outcomes
Primary outcome [1] 292860 0
Binge eating symptoms (ie eating quickly, eating until uncomfortably full, eating when not physically hungry, feeling embarrassed about eating, feeling disgusted/depressed or guilty about oneself) will be assessed by the Eating Disorder Examination
Timepoint [1] 292860 0
Pre-treatment and post-treatment (after session 10), at 3 months, 6 months and 12 months post-treatment
Primary outcome [2] 292861 0
Body weight will be measured with a scale and tape measure
Timepoint [2] 292861 0
Body weight and measurements will be taken after session 10, at 3 months, 6 months and 12 months post treatment
Secondary outcome [1] 309817 0
Trauma Symptoms (as measured by the Trauma Symptom Checklist/TSC 40),
Timepoint [1] 309817 0
TSC at post-treatment (session 10), 3 month, 6 month and 12 month post-treatment
Secondary outcome [2] 309882 0
Self-Esteem (as measured by Rosenberg Self-Esteem Scale),
Timepoint [2] 309882 0
Post-treatment (session 10), 3 month, 6-month and 12-month post-treatment follow-up
Secondary outcome [3] 309883 0
Physical Activity (as measured by the International Physical Activity Questionnaire/IPAQ)
Timepoint [3] 309883 0
Post-treatment (session 10, 3 month, 6-month and 12-month follow-up
Secondary outcome [4] 309884 0
Mental Health Symptoms as measured by the Depression, Anxiety and Stress/DASS21
Timepoint [4] 309884 0
Post-treatment (session 10), 3-month, 6-month and 12 month follow up

Eligibility
Key inclusion criteria
Male and female adults over 18 who are overweight or obese who have Binge Eating Disorder
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Borderline Personality Disorder; Alcohol or other Substance Dependence Disorder or use of Benzodiazepines or other drugs; epilepsy; on medication that affects weight/appetite; psychotic disorder; active suicidal ideation; underweight or normal weight; not meeting criteria for Binge Eating Disorder; pregnant or planning pregnancy in 6 months; legal problems related to weight/eating; not English speaking; not living in Sydney to be able to attend 10 sessions; unable to pay $10 per session; engaged in other weight control program; engaged with other mental health professional or struggling with other stressor

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
After screening out unsuitable candidates by the researcher, potential participants will be randomly assigned to treatment or wait-list control group by another researcher (central randomization by computer)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Participants are randomly allocated to receive either no intervention (wait-list control group) or the EMDR treatment (by one of 3 therapists providing the same treatment)
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Clinical and Statistical significance will be analyzed using a repeated ANOVA to compare change from pre to post treatment of 2 groups (treatment or no treatment). Analyses will be conducted on completers vs intent to treat analyses for all relevant variables. Groups will also be compared using t-tests and chi square analyses for demographic variables and baseline symptom measures.
Effect size to achieve sufficient power will be achieved at 52 participants. Sample Size calculations are based on power analyses conducted using GPower with alpha set at 0.05 and power=0.8 needing 52 participants for a large effect size between groups (n=26 per group)

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
21/08/2014
Actual
Date of last participant enrolment
Anticipated
11/12/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
52
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 289734 0
University
Name [1] 289734 0
University of Sydney
Country [1] 289734 0
Australia
Primary sponsor type
Individual
Name
Dr Katie Richard
Address
University of Sydney
Mackie Building Ko1
Arundel Street
Forest Lodge
NSW 2006
Country
Australia
Secondary sponsor category [1] 288427 0
None
Name [1] 288427 0
None
Address [1] 288427 0
Country [1] 288427 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291469 0
HREC University of Sydney
Ethics committee address [1] 291469 0
Ethics committee country [1] 291469 0
Australia
Date submitted for ethics approval [1] 291469 0
16/01/2014
Approval date [1] 291469 0
05/08/2014
Ethics approval number [1] 291469 0
2014/025

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

Contacts
Principal investigator
Name 50538 0
Dr Katie Richard
Address 50538 0
University of Sydney c/o Dr Maree Abbott
Mackie Building K01
Arundel Street
Forest Lodge
Sydney NSW 2006
Country 50538 0
Australia
Phone 50538 0
61-2-93512644
Fax 50538 0
Email 50538 0
[email protected]
Contact person for public queries
Name 50539 0
Katie Richard
Address 50539 0
University of Sydney
Psychology Dept
Mackie Building K01
Arundel Street
Forest Lodge
Sydney NSW 2006
Country 50539 0
Australia
Phone 50539 0
61-402676186
Fax 50539 0
Email 50539 0
[email protected]
Contact person for scientific queries
Name 50540 0
Maree Abbott
Address 50540 0
University of Sydney Psychology Dept
Mackie Building K01
Arundel Street
Forest Lodge
NSw 2006
Country 50540 0
Australia
Phone 50540 0
61-2-93512644
Fax 50540 0
Email 50540 0
[email protected]

No information has been provided regarding IPD availability


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
SourceTitleYear of PublicationDOI
EmbaseTreating binge eating disorder and obesity with eye movement desensitisation reprocessing.2018https://dx.doi.org/10.1159/000489691
N.B. These documents automatically identified may not have been verified by the study sponsor.