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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.
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.
Secondary ID [1] 283689 0
Nil known
Universal Trial Number (UTN)
U1111-1151-0077
Trial acronym
ATT (attention training therapy)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bulimia Nervosa 290654 0
Binge Eating Disorder 290655 0
Condition category
Condition code
Mental Health 291034 291034 0 0
Eating disorders

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 288390 0
Treatment: Other
Intervention code [2] 294793 0
Behaviour
Comparator / control treatment
A waitlist condition of 6 weeks will exist for the control treatment.
Control group
Active

Outcomes
Primary outcome [1] 291019 0
Change in body dissatisfaction as assessed by the EDE-Q
Timepoint [1] 291019 0
6 weeks (after treatment group or waitlist), and 4 weeks later
Primary outcome [2] 298354 0
Change in frequency of binge eating as assessed by EDE-Q
Timepoint [2] 298354 0
6 weeks (after treatment group or waitlist), and 4 weeks later
Primary outcome [3] 298355 0
A change in implicit attention bias towards trigger food words as measured by the Dot Probe
Timepoint [3] 298355 0
6 weeks (after treatment group or waitlist), and 4 weeks later
Secondary outcome [1] 305853 0
Change in co-morbidity of anxiety as assessed by DASS-21
Timepoint [1] 305853 0
6 weeks (after treatment group or waitlist), and 4 weeks later
Secondary outcome [2] 323926 0
Change in co-morbidity of depression as assessed by DASS-21
Timepoint [2] 323926 0
6 weeks (after treatment group or waitlist), and 4 weeks later

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
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
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.

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)
Allocation is not concealed
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.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
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.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
29/10/2013
Date of last participant enrolment
Anticipated
Actual
15/05/2015
Date of last data collection
Anticipated
Actual
22/05/2015
Sample size
Target
46
Accrual to date
Final
49
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 7607 0
2000 - Sydney

Funding & Sponsors
Funding source category [1] 288377 0
University
Name [1] 288377 0
University of Western Sydney
Country [1] 288377 0
Australia
Primary sponsor type
Individual
Name
Professor Stephen Touyz
Address
Psychology Clinic,
University of Sydney
Level 3
94 Mallett St
Camperdown
NSW 2050
Country
Australia
Secondary sponsor category [1] 287080 0
Individual
Name [1] 287080 0
Dr. Evelyn Smith
Address [1] 287080 0
Dr. Evelyn Smith
University of Western Sydney
Bankstown Campus
School of Social Sciences and Psychology
24.1.05
Bullecourt Ave,
Milperra
NSW 2214,
Australia
Country [1] 287080 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290257 0
Human Research Ethics Committee, University of Sydney
Ethics committee address [1] 290257 0
Ethics committee country [1] 290257 0
Australia
Date submitted for ethics approval [1] 290257 0
28/10/2011
Approval date [1] 290257 0
19/11/2012
Ethics approval number [1] 290257 0
HREC APPROVAL NUMBER 5338

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

Contacts
Principal investigator
Name 44726 0
Prof Stephen Touyz
Address 44726 0
University of Sydney
Psychology Clinic,
Level 3
94 Mallett St
Camperdown
NSW 2050
Country 44726 0
Australia
Phone 44726 0
+61 421 922 678
Fax 44726 0
Email 44726 0
[email protected]
Contact person for public queries
Name 44727 0
Nadine-Devaki Wright
Address 44727 0
C/o Prof Touyz
University of Sydney
Psychology Clinic,
Level 3
94 Mallett St
Camperdown
NSW 2050
Country 44727 0
Australia
Phone 44727 0
+61 421 922 678
Fax 44727 0
Email 44727 0
[email protected]
Contact person for scientific queries
Name 44728 0
Nadine-Devaki Wright
Address 44728 0
C/o Prof Touyz
University of Sydney
Psychology Clinic,
Level 3
94 Mallett St
Camperdown
NSW 2050
Country 44728 0
Australia
Phone 44728 0
+61 421 922 678
Fax 44728 0
Email 44728 0
[email protected]

No information has been provided regarding IPD availability


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No Supporting Document Provided



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