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Trial registered on ANZCTR


Registration number
ACTRN12607000440426
Ethics application status
Approved
Date submitted
30/08/2007
Date registered
31/08/2007
Date last updated
28/06/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
The Efficacy of Therapeutic Treatments in Chronic Anorexia Nervosa
Scientific title
A randomised control trial of nonspecific supportive clinical management (NSCM) versus Cognitive Behaviour Therapy (CBT) in chronic anorexia nervosa
Secondary ID [1] 252118 0
Andreea Heriseanu
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anorexia nervosa 2256 0
Condition category
Condition code
Mental Health 2102 2102 0 0
Eating disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will compare the established therapy, Cognitive Behaviour Therapy (CBT), with the most promising therapy to emerge in the recent anorexia nervosa (AN) literature, Non-specific Supportive Clinical Management (NSCM), in a chronic anorexia nervosa (C-AN) sample. To accomplish these aims, 90 females over the age of 18, meeting the Diagnostic and Statistical Manual of Mental Disorders 4th edition (DSM IV) criteria for AN for more than seven years will be randomly assigned to one of two manualised treatment conditions, CBT or NSCM. Both treatments will involve 30 individual treatment sessions over 6 months. All patients will be monitored for six months after the end of treatment. Assessments will occur at baseline, 15 weeks into treatment, end of treatment, and six months post-treatment. The primary outcome will be the change in measures assessing chronicity, i.e., Quality of Life (QoL), depression and social isolation. The secondary outcomes will include change in core eating disorder (ED) pathology, motivation for change and use of medical services (the number of hospital days, GP and specialist visits).
NSCM fosters a therapeutic relationship that promotes adherence to treatment, without imposing assumptions about change; it includes education, care and support for change, without necessitating it. The treatment does not aim to restore weight, but supports patients in making any changes that will improve QoL and physical well-being, including, but not exclusively, weight change. CBT actively targets food and weight increases by having the patient challenge Eating Disorder (ED) behaviours and underlying maladaptive cognitions around food, body, weight and shape. CBT is an active treatment aimed at acheiving some weight gain and the reumption of normal eating habits by challenging underlying beliefs and thoughts through cognitive restructuring and behaviour change. This trial will involve two treatments sites and one data management site. Treatment Site 1: University of Sydney, School of Psychology Treatment Site 2: University of London, St George's School of Medicine Data Management Site: University of Chicago, Pritzker School of Medicine This innovative project will provide the world's first information about potentially effective treatments for this highly debilitated group who have proved very difficult for professionals to treat thus far. It will be the largest study ever conducted on C-AN anywhere in the world.
Intervention code [1] 1986 0
Treatment: Other
Comparator / control treatment
There is no ‘control’ group – we are comparing 2 effective treatments
Control group
Active

Outcomes
Primary outcome [1] 3265 0
Change in measures assessing chronicity, i.e., QoL, depression and social isolation.
Timepoint [1] 3265 0
There will be 4 major assessment points (before treatment, 15 weeks into treatment, at the conclusion of treatment and 6 months after the completion of treatment). The assessment will involve standardised clinical interviews and questionnaires, physical examinations and clinical laboratory investigations. The initial psychological assessments will be conducted by a research assistant trained in their administration and scoring. This research assistant will not be involved in patient treatment. Subsequent assessments (15 weeks, completion of treatment, 6 month follow-up) will be conducted by an independent assessor trained by the research assistant and blind to the patient's treatment condition. Physical examinations will be carried out by the patient's GP and clinical investigations will be done through appropriate Pathology and Radiology services.
Secondary outcome [1] 5446 0
Change in core ED pathology, motivation for change and use of medical services (the number of hospital days, GP and specialist visits)
Timepoint [1] 5446 0
There will be 4 major assessment points (before treatment, 15 weeks into treatment, at the conclusion of treatment and 6 months after the completion of treatment). The assessment will involve standardised clinical interviews and questionnaires, physical examinations and clinical laboratory investigations. The initial psychological assessments will be conducted by a research assistant trained in their administration and scoring. This research assistant will not be involved in patient treatment. Subsequent assessments (15 weeks, completion of treatment, 6 month follow-up) will be conducted by an independent assessor trained by the research assistant and blind to the patient's treatment condition. Physical examinations will be carried out by the patient's GP and clinical investigations will be done through appropriate Pathology and Radiology services.

Eligibility
Key inclusion criteria
Subjects will meet the DSM-IV (Diagnostic and Statistical Manual of Mental Disorders 4th Edition) criteria for AN for more that 7 years (even if there have been periods of recovery). Females over the age of 18. Subjects up to a Body Mass Index (BMI) of 18.5 can participate as long as menstruation has not returned. Underweight patients who meet all criteria bar that for amenorrhea can participate. All subjects will have provided informed consent prior to their inclusion in the study.
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Current manic episode or psychosis, current alcohol or substance abuse or dependence, currently engaged in psychotherapy or self-help treatment modalities for the eating disorder and not willing to forego these for the duration of their participation in the trial, significant current medical or neurological illness (including seizure disorder), with the exception of nutrition-related alterations that impacts on weight, plans to move beyond commuting distance from the study site in the following 12 months, does not live within commuting distance to the study site.

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)
The subject will participate in an initial screening interview. If they meet eligibility criteria, consistent with the CONSORT statement, randomisation will be organised by the Chicago site, which will serve as the data centre for the two clinical sites. Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be individually randomised using an Excel Program, Ephron’s Biased Coin. Randomisation will be stratified by subtype of illness (AN-R vs AN-BP) and whether a participant is on psychotropic medication.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The people assessing the outcomes will be blind to treatment allocation
The data analyst will be blind to treatment allocation.
Phase
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 375 0
2000
Recruitment outside Australia
Country [1] 474 0
United Kingdom
State/province [1] 474 0

Funding & Sponsors
Funding source category [1] 2521 0
Government body
Name [1] 2521 0
National Health and Medical Research Council
Address [1] 2521 0
Canberra
Country [1] 2521 0
Australia
Primary sponsor type
University
Name
University of Sydney - School of Psychology
Address
University of Sydney,
Sydney 2006
Country
Australia
Secondary sponsor category [1] 2033 0
None
Name [1] 2033 0
Address [1] 2033 0
Country [1] 2033 0
Other collaborator category [1] 21 0
University
Name [1] 21 0
University of London, St George's School of Medicine
Address [1] 21 0
London
Country [1] 21 0
United Kingdom
Other collaborator category [2] 22 0
University
Name [2] 22 0
University of Chicago, Pritzker School of Medicine
Address [2] 22 0
Chicago
Country [2] 22 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4424 0
Human Research Ethics Committee - The University of Sydney
Ethics committee address [1] 4424 0
Ethics committee country [1] 4424 0
Australia
Date submitted for ethics approval [1] 4424 0
Approval date [1] 4424 0
01/02/2007
Ethics approval number [1] 4424 0
02-2007/9669

Summary
Brief summary
This study will compare Cognitive Behaviour Therapy (CBT) with Non-specific Supportive Clinical Management (NSCM), in a chronic anorexia nervosa (C-AN) sample. Subjects will include 90 females over the age of 18, meeting the Diagnostic and Statistical Manual of Mental Disorders 4th edition (DSM IV) criteria for AN for more than seven years (even if there have been periods of recovery). Individuals will be randomly assigned to either CBT or NSCM and will receive 30 treatment sessions over 6 months. All patients will be monitored for six months after the end of treatment. Assessments will occur at the start of treatment, 15 weeks into treatment, end of treatment, and six months after treatment. Interpretation of Results This study aims to compare outcomes between individuals with chronic anorexia (C-AN) who receive CBT and those who receive NSCM. It is hypothesised that these treatments will influence an individual's quality of life, level of depression and social isolation. It is also thought that there will be changes in an individual's core eating disorder pathology, in their motivation for change and a reduction in the use of medical services. This innovative project will provide the world's first information about potentially effective treatments for chronic anorexia nervosa. It will be the largest study ever conducted on C-AN anywhere in the world.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27501 0
Address 27501 0
Country 27501 0
Phone 27501 0
Fax 27501 0
Email 27501 0
Contact person for public queries
Name 10756 0
Rebecca Smith
Address 10756 0
The University of Sydney
Clinical Psychology Unit
Transient Building (F12)
Country 10756 0
Australia
Phone 10756 0
+61 2 9351 7329
Fax 10756 0
+61 2 9351 2984
Email 10756 0
rebeccas@psych.usyd.edu.au
Contact person for scientific queries
Name 1684 0
Professor Stephen Touyz
Address 1684 0
The University of Sydney
Clinical Psychology Unit
Transient Building (F12)
Country 1684 0
Australia
Phone 1684 0
+61 2 9351 2646
Fax 1684 0
+61 2 9351 2984
Email 1684 0
stephent@psych.usyd.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary