Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000721606
Ethics application status
Approved
Date submitted
16/09/2005
Date registered
9/11/2005
Date last updated
12/01/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Enhancing psychotherapy for bulimia nervosa and binge eating disorder
Scientific title
A randomised trial of cognitive behaviour therapy, schema focussed therapy and appetite enhanced cognitive therapy in the treatment for bulimia nervosa and binge eating disorder to reduce the frequency of binge eating episodes after six months of weekly and six months of monthly therapy
Secondary ID [1] 290422 0
Nil known
Universal Trial Number (UTN)
Trial acronym
BEP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bulimia nervosa and binge eating disorder 871 0
Binge eating disorder 872 0
Condition category
Condition code
Diet and Nutrition 939 939 0 0
Other diet and nutrition disorders
Mental Health 940 940 0 0
Eating disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
CBT-B (Beck); CBT-S (Schema focused); CBT-A (Appetite enhanced).
Duration: 12 months.
Intervention code [1] 644 0
None
Comparator / control treatment
CBT-B
Control group
Active

Outcomes
Primary outcome [1] 1233 0
To examine whether it is possible to improve the outcome of BN and BED treatment by enhancing cognitive component of standard CBT. Standard CBT will be compared with two enhanced forms of CBT - schema therapy and nutrition and appetite enhanced CBT.
Timepoint [1] 1233 0
End of treatment (12 months)
Primary outcome [2] 1234 0
To examine whether it is possible to improve the outcome of BN and BED treatment by enhancing the nutritional component of standard CBT. Standard CBT will be compared with two enhanced forms of CBT - schema therapy and nutrition and appetite enhanced CBT.
Timepoint [2] 1234 0
End of treatment (12 months)
Primary outcome [3] 1235 0
Binge eating (frequency of binges per week)
Timepoint [3] 1235 0
End of treatment (12 months)
Secondary outcome [1] 2246 0
i) Recovery, defined as abstinence from binging, purging and the absence of any eating disorder diagnosis
Timepoint [1] 2246 0
Outcomes are measured at end of treatment (12 months).
Secondary outcome [2] 2247 0
ii) Clinician-rated EDE subscales (sum): Restraint, bulimia, eating concerns, weight concerns, shape concerns
Timepoint [2] 2247 0
Outcomes are measured at end of treatment (12 months).
Secondary outcome [3] 2248 0
iii) Clinician-rated: Global Assessment of Functioning, Axis V of DSM-IV
Timepoint [3] 2248 0
Outcomes are measured at end of treatment (12 months).
Secondary outcome [4] 2249 0
iv) Weight
Timepoint [4] 2249 0
Outcomes are measured at end of treatment (12 months).
Secondary outcome [5] 2250 0
v) Number of days per week on which binge eating occurs
Timepoint [5] 2250 0
Outcomes are measured at end of treatment (12 months).
Secondary outcome [6] 2251 0
vi) Cliinician-rated: Global Eating Disorder Status
Timepoint [6] 2251 0
Outcomes are measured at end of treatment (12 months).
Secondary outcome [7] 2252 0
vii) Eating disorder symptoms: number of purges, dietary restriction
Timepoint [7] 2252 0
Outcomes are measured at end of treatment (12 months).
Secondary outcome [8] 2253 0
viii) Self-report: EDI subscales: Drive for Thiness, Body Dissatisfaction, Bulimia.
Timepoint [8] 2253 0
Outcomes are measured at end of treatment (12 months).

Eligibility
Key inclusion criteria
i) current primary diagnosis of BN or BED; ii) Body mass index (BMI) > 17.5.
Minimum age
16 Years
Maximum age
Not stated
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Current severe major depression (HDRS>20); ii) current severe psychoactive substance dependence; iii) current or past bipolar I disorder or schizophrenia; iv) developmental learning disorder or cognitive impairment; v) major medical or neurological illness; vi) current severe medical complications of an eating disorder; vii) currently taking psychoactive medication and unwilling to undergo a supervised drug wash-out period (the longer of two weeks or five drug half-lives); viii) failure to respond to a previous adequate trial of one of the psychotherapies in this study.

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)
Sealed envelope.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated permutated block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
17/05/2005
Actual
17/05/2005
Date of last participant enrolment
Anticipated
Actual
5/10/2010
Date of last data collection
Anticipated
Actual
2/03/2016
Sample size
Target
200
Accrual to date
Final
112
Recruitment outside Australia
Country [1] 8359 0
New Zealand
State/province [1] 8359 0
Canterbury

Funding & Sponsors
Funding source category [1] 1038 0
Government body
Name [1] 1038 0
Health Research Council of New Zealand
Country [1] 1038 0
New Zealand
Primary sponsor type
Government body
Name
Health Research Council of New Zealand
Address
Level 3 - ProCARE Building, Grafton Mews, at 110 Stanley Street, Auckland 1010
Postal Address PO Box 5541, Wellesley Street, Auckland 1141
Country
New Zealand
Secondary sponsor category [1] 900 0
None
Name [1] 900 0
Not applicable
Address [1] 900 0
Country [1] 900 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2338 0
Christchurch
Ethics committee address [1] 2338 0
Ministry of Health
PO Box 3877
Christchurch 8013
Ethics committee country [1] 2338 0
New Zealand
Date submitted for ethics approval [1] 2338 0
03/08/2004
Approval date [1] 2338 0
10/09/2004
Ethics approval number [1] 2338 0
CTB/04/08/139

Summary
Brief summary
Bulimia nervosa (BN) and binge eating disorder (BED) are eating disorders that share a pattern of binge eating or overeating within discrete short time periods. CBT is the most effective treatment for BN and BED, and uses both cognitive and behavioural strategies. However, in spite of CBT being the most effective treatment for BN and BED, fewer than half of individuals fully recover. The proposed study aims to evaluate whether the effectiveness of standard CBT may be enhanced in two different ways. Schema therapy (ST) enhances the cognitive component of CBT by focusing on changing deeper level beliefs or schemas. Appetite enhanced CBT (CBT-A) enhances the behavioural component of CBT by focusing on hunger and satiety. The study will randomise women with BN or BED to standard CBT, ST or CBT-A
Trial website
Trial related presentations / publications
McIntosh, V. V. W., Jordan, J., Carter, J. D., Frampton, C. M. A., McKenzie, J. M., Latner, J. D., & Joyce, P. R. Psychotherapy for transdiagnostic binge eating: A randomized controlled trial of cognitive-behavioural therapy, appetite-focused cognitive-behavioural therapy, and schema therapy. Psychiat Res 2016; 240, 412-420.

Jordan J, McIntosh VVW, Carter JD, Rowe S, Taylor K, Frampton CMA, et al. Bulimia nervosa-non purging subtype: Closer to the bulimia nervosa-purging subtype or to binge eating disorder? Int J Eat Disord. 2014, 47(3):231-238.
Public notes

Contacts
Principal investigator
Name 35964 0
Prof Peter Joyce
Address 35964 0
Department of Psychological Medicine, UOC, PO Box 4345, Christchurch 8001
Country 35964 0
New Zealand
Phone 35964 0
+64 3 372 0400
Fax 35964 0
Email 35964 0
[email protected]
Contact person for public queries
Name 9833 0
Dr Virginia McIntosh
Address 9833 0
Psychology Department,
University of Canterbury
Private Bag 4800
Christchurch 8140
New Zealand
Country 9833 0
New Zealand
Phone 9833 0
: +64,3,3694333
Fax 9833 0
+64 3 3642181
Email 9833 0
[email protected]
Contact person for scientific queries
Name 761 0
Dr Virginia McIntosh
Address 761 0
Psychology Department,
University of Canterbury
Private Bag 4800
Christchurch 8140
New Zealand
Country 761 0
New Zealand
Phone 761 0
+64,3,3,694333
Fax 761 0
+64 3 3642181
Email 761 0
[email protected]

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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