Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000585022
Ethics application status
Approved
Date submitted
1/03/2010
Date registered
21/07/2010
Date last updated
13/09/2023
Date data sharing statement initially provided
13/09/2023
Date results provided
13/09/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Moving forward in anorexia nervosa treatment.
Scientific title
A randomised controlled trial of the Loughborough Eating disorders Activity therapy versus general cognitive behavior therapy efficacy in reducing pathological exercise behaviours and cognitions.
Secondary ID [1] 1159 0
National Health and Medical Research Council (NHMRC) protocol 634922
Universal Trial Number (UTN)
U1111-1112-6553
Trial acronym
LEAP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anorexia nervosa 252314 0
Condition category
Condition code
Mental Health 252494 252494 0 0
Eating disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention tested is an extended manualised cognitive behaviour therapy.The overarching aim is the promotion of ‘healthy’ (i.e., non-excessive/non-eating disorder related) attitudes, beliefs, and behaviours toward both structured exercise and physical activity in general. It is important to emphasise that the aim of the treatment program is not to make patients stop exercising, but rather to educate them about what constitutes ‘healthy/non-excessive’ exercise and equip them with the knowledge and skills that will enable them to regain control of their exercise behaviour in order to participate in age, goal and health-status appropriate exercise. The program is designed around four core themes of education, guided discovery, cognitive skills, and relapse prevention. Specifically the following are addressed:
Education about the cognitive view on the maintenance of excessive exercise
Promotion of insight into the factors affecting (maintaining) the patient’s attitudes, beliefs and behaviours toward exercise
Education about what constitutes ‘healthy’ exercise
Introduction to the cognitive skills and strategies necessary to challenge maladaptive attitudes, beliefs and behaviours toward exercise
Introduction to alternative (adaptive) emotion coping strategies
Education about relapse prevention

We expect reduced driven exercise behaviour and cognitions.
The intervention will be administered during day time hours by a trained therapist. The therapy will comprise 8 weekly one hour sessions and is followed by 6-8 months of weekly cognitive behaviour therapy and then 6 months follow-up after that. The cognitive behaviour therapy admistered in the next 6-8 months (or 8-10 months in the control therapy group) is that developed by Pike et al. (Pike KM, Walsh BT, Vitousek K, et al. Cognitive behavior therapy in the post-hospitalization treatment of anorexia nervosa. Am J Psychiatry,2003; 160, 2046-2049.) All therapy is administered on an individual basis.
Intervention code [1] 255621 0
Treatment: Other
Comparator / control treatment
Cognitive behaviour therapy (CBT) is an active treatment aimed at restoring weight and normal eating habits by challenging underlying beliefs and thoughts through cognitive restructuring and behaviour change. The CBT utilised in this study follows three clearly defined phases of treatment and to accommodate the present study aims the phases are 34 weeks duration. The three broad phases are:
Phase I: Building trust and setting treatment parameters. In the first phase of treatment, the principal aims are to build a positive therapeutic alliance, assessing key features of the eating disorder, providing education about starvation symptoms and other related topics, giving a rationale and advice for restoring normal nutrition and body weight, and prescribing eating patterns and establishing a regular eating pattern. Interventions are aimed at regulating the chronic dieting with the focus on helping patients to eat regular meals at regular times.
Phase II: Changing beliefs related to food and weight, then broadening the scope of therapy. The principal aims of this phase of treatment are to continue the emphasis on weight gain and normalising eating and to bring these about by reframing relapse, identifying dysfunctional thoughts, schemas and thinking patterns, developing cognitive restructuring skills, modifying self-concept, and developing an interpersonal focus in therapy.
Phase III: Preventing relapse and preparing for termination. The final phase, relapse prevention, clarifies the changes the patient has already made, and prepares the patient for residual problems that may be found once treatment has been terminated.
We expect improved weight and reduced eating disorder thoughts and behaviours after the CBT therapy.
CBT will be delivered once over 8-10 months in 50 minute weekly sessions and followup is to 6 months. It is delivered on an individual (not group) basis by a psychologist. Both the intervention and the comparator group recieve the same cognitive behaviour therapy but it is shorter in the intervention group to allow for additional sessions of Loughborough Eating and Activity TheraPy (LEAP).
Control group
Active

Outcomes
Primary outcome [1] 253381 0
Reduction in pathological exercise behaviours and cognitions by questionnaires (The Commitment to Exercise Scale , Compulsive Exercise Test , Exercise Beliefs Questionnaire )
Timepoint [1] 253381 0
After 10 sessions and after 20 sessions, end therapy after 34 sessions or final session, 3 and 6 months follow-up
Secondary outcome [1] 262467 0
Improved weight , by measurement weight with balance beam scales.
Timepoint [1] 262467 0
After 10 sessions and after 20 sessions, end therapy after 34 sessions or final session, 3 and 6 months follow-up
Secondary outcome [2] 263442 0
Reduction in eating disorder cognitions by interview (the Eating Disorder Examination)
Timepoint [2] 263442 0
After 10 sessions and after 20 sessions, end therapy after 34 sessions or final session, 3 and 6 months follow-up

Eligibility
Key inclusion criteria
Age >18 years with primary diagnosis of anorexia nervosa according to American Psychiatric Association Diagnostic and Statistical Manual version IV (DSM-IV) of either the restrictive or binge-purge type.
Engaging in some form of exercise behaviour over the previous week. Therefore, they will each score >/=1 on item 2 on the Exercise Participation Screening Questionnaire.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Diagnosis of psychosis or bipolar disorder
A high level of suicide risk and/or medical compromise precluding outpatient care and/or body mass index (BMI) < 14.

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)
Initial contact will be by clinic referral or inquiry from advertising. Potential subjects will be screened for eligibility either over the phone or via email. Screening will identify those patients at least 18 years and likely to meet eligibility criteria, particularly current exercise. Those deemed eligible will be scheduled for further assessment including obtaining informed consent. Assessment procedures will include an exercise frequency measure, BMI and the structured clinical interview for the diagnostic and statistical manual of mental disorders (Spitzer et al., 1992)) to determine diagnosis/co-morbid diagnoses and suicide risk. Allocation will be by an independent investigator blind to the findings of the assessment (accepting that the person is eligible).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization will use an internet assisted scheme (sealedenvelope.com) according to biased coin method and will be stratified by location, subtype of illness and whether a participant is on psychotropic medication.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2010
Actual
19/08/2010
Date of last participant enrolment
Anticipated
28/02/2015
Actual
30/01/2015
Date of last data collection
Anticipated
Actual
2/05/2016
Sample size
Target
100
Accrual to date
Final
78
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 2344 0
United Kingdom
State/province [1] 2344 0
Loughborough
Country [2] 7247 0
United States of America
State/province [2] 7247 0
New York

Funding & Sponsors
Funding source category [1] 256103 0
Government body
Name [1] 256103 0
NHMRC
Country [1] 256103 0
Australia
Primary sponsor type
University
Name
University of Western Sydney
Address
Locked Bag 1797
Penrith South DC
1797 NSW
Country
Australia
Secondary sponsor category [1] 256203 0
None
Name [1] 256203 0
Address [1] 256203 0
Country [1] 256203 0
Other collaborator category [1] 982 0
University
Name [1] 982 0
University of Sydney
Address [1] 982 0
The University of Sydney
NSW 2006
Australia
Country [1] 982 0
Australia
Other collaborator category [2] 983 0
University
Name [2] 983 0
University of Loughborough
Address [2] 983 0
Leicestershire, UK
LE11 3TU
Country [2] 983 0
United Kingdom
Other collaborator category [3] 278661 0
Individual
Name [3] 278661 0
Prof Evelyn Attia
Address [3] 278661 0
Department of Psychiatry
Columbia University
21 Bloomingdale Road
White Plains, NY 10605
USA
Country [3] 278661 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258615 0
University of Western Sydney Human Research Ethics Committee
Ethics committee address [1] 258615 0
Ethics committee country [1] 258615 0
Australia
Date submitted for ethics approval [1] 258615 0
Approval date [1] 258615 0
24/02/2010
Ethics approval number [1] 258615 0
H7732

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

Contacts
Principal investigator
Name 30560 0
Prof Phillipa Hay
Address 30560 0
Centre for Health Research
School of Medicine
Locked Bag 1797
Penrith UWS 2751
Country 30560 0
Australia
Phone 30560 0
+61 412330428
Fax 30560 0
+61 2 46203891
Email 30560 0
[email protected]
Contact person for public queries
Name 13807 0
Professor Phillipa Hay
Address 13807 0
School of Medicine
University of Western Sydney (UWS)
Locked bag 1797
Penrith South DC NSW 1797
Country 13807 0
Australia
Phone 13807 0
+61 412330428
Fax 13807 0
Email 13807 0
[email protected]
Contact person for scientific queries
Name 4735 0
Professor Phillipa Hay
Address 4735 0
School of Medicine
University of Western Sydney (UWS)
Locked bag 1797
Penrith South DC NSW 1797
Country 4735 0
Australia
Phone 4735 0
+61 412330428
Fax 4735 0
Email 4735 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


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
Dimensions AICurrent treatment for anorexia nervosa: efficacy, safety, and adherence2010https://doi.org/10.2147/prbm.s13814
N.B. These documents automatically identified may not have been verified by the study sponsor.