ANZCTR - Registration

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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]

Andreea Heriseanu

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Anorexia nervosa

Condition category

Condition code

Mental Health

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]

Treatment: Other

Comparator / control treatment

There is no ‘control’ group – we are comparing 2 effective treatments

Control group

Active

Outcomes

Primary outcome [1]

Change in measures assessing chronicity, i.e., QoL, depression and social isolation.

Timepoint [1]

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]

Change in core ED pathology, motivation for change and use of medical services (the number of hospital days, GP and specialist visits)

Timepoint [1]

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

Sex

Females

Can healthy volunteers participate?

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

1/10/2007

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]

2000

Recruitment outside Australia

Country [1]

United Kingdom

State/province [1]

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council

Address [1]

Canberra

Country [1]

Australia

Primary sponsor type

University

Name

University of Sydney - School of Psychology

Address

University of Sydney,
Sydney 2006

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

University

Name [1]

University of London, St George's School of Medicine

Address [1]

London

Country [1]

United Kingdom

Other collaborator category [2]

University

Name [2]

University of Chicago, Pritzker School of Medicine

Address [2]

Chicago

Country [2]

United States of America

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Human Research Ethics Committee - The University of Sydney

Ethics committee address [1]

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

01/02/2007

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Rebecca Smith

Address

The University of Sydney
Clinical Psychology Unit
Transient Building (F12)

Country

Australia

Phone

+61 2 9351 7329

Fax

+61 2 9351 2984

[email protected]

Contact person for scientific queries

Name

Professor Stephen Touyz

Address

The University of Sydney
Clinical Psychology Unit
Transient Building (F12)

Country

Australia

Phone

+61 2 9351 2646

Fax

+61 2 9351 2984

[email protected]

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

Source	Title	Year of Publication	DOI
Dimensions AI	Predictors of therapeutic alliance in two treatments for adults with severe and enduring anorexia nervosa	2016	https://doi.org/10.1186/s40337-016-0102-6

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically