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Trial registered on ANZCTR
Registration number
ACTRN12616001294448
Ethics application status
Approved
Date submitted
17/05/2016
Date registered
14/09/2016
Date last updated
14/09/2016
Type of registration
Retrospectively registered
Titles & IDs
Public title
Assessing the effectiveness of attention training therapy in the treatment of binge eating within bulimia nervosa and binge eating disorder - a randomised controlled trial.
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Scientific title
Assessing the effectiveness of attention training therapy in the treatment of binge eating within bulimia nervosa and binge eating disorder in females aged 18-45 years - a randomised controlled trial.
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Secondary ID [1]
283689
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Nil known
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Universal Trial Number (UTN)
U1111-1151-0077
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Trial acronym
ATT (attention training therapy)
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Bulimia Nervosa
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Binge Eating Disorder
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Condition category
Condition code
Mental Health
291034
291034
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0
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Eating disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
This study aims to evaluate the efficacy of manual-based Attention Training Therapy (ATT) for individuals with BN and BED compared to a waitlist control condition.
The ATT program employed is a modified version of ATT designed and evaluated for social phobia (Donald et. al., 2012).
a) The treatment resources and materials to trialed involve a clinician’s manual. This includes the rationale for the session, in session activities, worksheets and homework tasks to be given to the participants on a weekly basis
b) Participants in the ATT programme will be introduced to the graded attention and concentration training program task. The three main areas of the program are focusing, strengthening and shifting of attention. ATT will aim at helping participants train their attention away from unhelpful thoughts and re-direct their attention to the ‘task at hand’. Participants will be introduced to attentional exercises using internal stimuli. This includes a body scan exercise to help participants accept their body’s feelings and associated triggers, rather than react emotively to them. Participants are introduced to the idea of ‘symptom surfing’, which is a way of accepting or ‘riding out’ the emotions or triggers, rather than focusing on them or fighting against them. Participants are led through a ‘three minute breathing space’ exercise in which they are trained to remain in the moment, to help them disengage from unhelpful thoughts.
Participants will complete a tracking questionnaire each week. Participants will also complete 1) the therapeutic alliance, 2) the group alliance/cohesion assessment, and 3) confidence in treatment questionnaire after week 1, week 3 and week 6.
c) A clinical psychologist with a minimum of two years experience working with the treatment of Eating Disorders will deliver the treatment. A co-facilitator will be present who will be a clinical psychology student.
d) The mode of delivery is face to face and it will be provided in a group (maximum 8 people per group).
e) This treatment is a two hour session once a week over six weeks.
f) The location where the intervention occurs is in an urban psychology clinic
3. Given the manual aspect of this intervention, it is not personalized, titrated or adapted to individuals.
4. Group attendance is taken and participants who do not attend will contacted and offered a make up session before the next week to ensure they keep up. No strategies will be used to maintain or improve fidelity.
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Intervention code [1]
288390
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Treatment: Other
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Intervention code [2]
294793
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Behaviour
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Comparator / control treatment
A waitlist condition of 6 weeks will exist for the control treatment.
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Control group
Active
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Outcomes
Primary outcome [1]
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Change in body dissatisfaction as assessed by the EDE-Q
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Assessment method [1]
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Timepoint [1]
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6 weeks (after treatment group or waitlist), and 4 weeks later
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Primary outcome [2]
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Change in frequency of binge eating as assessed by EDE-Q
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Assessment method [2]
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Timepoint [2]
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6 weeks (after treatment group or waitlist), and 4 weeks later
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Primary outcome [3]
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A change in implicit attention bias towards trigger food words as measured by the Dot Probe
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Assessment method [3]
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Timepoint [3]
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6 weeks (after treatment group or waitlist), and 4 weeks later
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Secondary outcome [1]
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Change in co-morbidity of anxiety as assessed by DASS-21
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Assessment method [1]
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Timepoint [1]
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6 weeks (after treatment group or waitlist), and 4 weeks later
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Secondary outcome [2]
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Change in co-morbidity of depression as assessed by DASS-21
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Assessment method [2]
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Timepoint [2]
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6 weeks (after treatment group or waitlist), and 4 weeks later
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Eligibility
Key inclusion criteria
Key inclusion is
- female
- Between the age of 18-45
- fluent English speaker
- a diagnosis of BN or BED (determined by a clinician trained in administering and interpreting the EDE (Eating Disorder Examination)
- able to attend the face-to-face group sessions
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Minimum age
18
Years
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Maximum age
45
Years
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusion criteria will include any major medical condition that would interfere with treatment or require alternative treatment, alcohol or drug dependence in the last three months and any current significant suicidal ideation or intent, or active psychosis.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Suitable participants are randomly allocated to one of the two conditions with the help of an online research randomiser (www.randomizer.org) via block randomisation.
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
We are expecting a medium size effect, at power 0.8, alpha of 0.05, and one tailed approach, G3 suggest 23 people per group.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
29/10/2013
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Date of last participant enrolment
Anticipated
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Actual
15/05/2015
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Date of last data collection
Anticipated
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Actual
22/05/2015
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Sample size
Target
46
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Accrual to date
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Final
49
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment postcode(s) [1]
7607
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2000 - Sydney
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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University of Western Sydney
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Address [1]
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Dr. Evelyn Smith
University of Western Sydney
Bankstown Campus
School of Social Sciences and Psychology
24.1.05
Bullecourt Ave,
Milperra
NSW 2214,
Australia
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Country [1]
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Australia
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Primary sponsor type
Individual
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Name
Professor Stephen Touyz
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Address
Psychology Clinic,
University of Sydney
Level 3
94 Mallett St
Camperdown
NSW 2050
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Country
Australia
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Secondary sponsor category [1]
287080
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Individual
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Name [1]
287080
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Dr. Evelyn Smith
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Address [1]
287080
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Dr. Evelyn Smith
University of Western Sydney
Bankstown Campus
School of Social Sciences and Psychology
24.1.05
Bullecourt Ave,
Milperra
NSW 2214,
Australia
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Country [1]
287080
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Human Research Ethics Committee, University of Sydney
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Ethics committee address [1]
290257
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HRECS
Level 6
Jane Foss Russell
G02 Building
The University of Sydney
NSW 2006 AUSTRALIA
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Ethics committee country [1]
290257
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Australia
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Date submitted for ethics approval [1]
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28/10/2011
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Approval date [1]
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19/11/2012
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Ethics approval number [1]
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HREC APPROVAL NUMBER 5338
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Summary
Brief summary
Primary purpose of this study is to evaluate the efficacy of manual-based ATT for individuals with BN and BED compared to a waitlist control condition.
Brief statement intended for the lay public:
Researchers at the University of Sydney and the University of Western Sydney are conducting a study examining the effect of attention training on binge eating. We
hope to learn whether Attention Training Therapy (ATT) is helpful in reducing symptoms of binge eating, characteristic of individuals with Bulimia Nervosa and Binge Eating Disorder.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Stephen Touyz
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Address
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University of Sydney
Psychology Clinic,
Level 3
94 Mallett St
Camperdown
NSW 2050
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Country
44726
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Australia
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Phone
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+61 421 922 678
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Ms Nadine-Devaki Wright
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Address
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C/o Prof Touyz
University of Sydney
Psychology Clinic,
Level 3
94 Mallett St
Camperdown
NSW 2050
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Country
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Australia
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Phone
44727
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+61 421 922 678
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
44728
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Ms Nadine-Devaki Wright
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Address
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C/o Prof Touyz
University of Sydney
Psychology Clinic,
Level 3
94 Mallett St
Camperdown
NSW 2050
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Country
44728
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Australia
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Phone
44728
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+61 421 922 678
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Fax
44728
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Email
44728
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[email protected]
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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
No additional documents have been identified.
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