Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000009415
Ethics application status
Approved
Date submitted
20/12/2006
Date registered
8/01/2007
Date last updated
17/08/2007
Type of registration
Prospectively registered

Titles & IDs
Public title
The Impact of Inpatient Weight Restoration in Adoelscent Anorexia Nervosa
Scientific title
Does inpatient weight restoration prior to outpatient family therapy improve psychological and physical outcomes in adolescent anorexia nervosa
Universal Trial Number (UTN)
Trial acronym
EDRCT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Adolescent Anorexia Nervosa 1512 0
Condition category
Condition code
Mental Health 1610 1610 0 0
Eating disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study examines the effect of length of hospital admission for refeeding, prior to manualised outpatient family therapy on outcomes for patients with AN. Subjects will include 72 children and adolescents aged 10 to 18 years admitted for medical management of AN of less than 3 years duration. This study aims to randomly allocate and compare outcomes between individuals with AN admitted for medical stabilisation, approximately 2 to 3 weeks, followed by 20 one hour sessions of outpatient family therapy over a 12 month period versus those admitted for full weight restoration, approximately 9 to 12 weeks also followed by 20 one hour sessions of outpatient family therapy. Physical and psychological outcomes will be measured at admission, at discharge from hospital, completion of outpatient treatment and at 6 and 12 months following outpatient treatment.

Medical Compromise
Medical compromise will be defined by the presence of one or more of the following:
Heart rate of less than 50 beats per minute
Blood pressure below 80mm Hg diastolic and 40 systolic mm Hg
A postural blood pressure drop of greater than 10mm of Hg
The presence of cardiac arrhythmia’s on electrocardiograph
A temperature below 35.5 C
Electrolyte abnormalities
A weight below 75% of predicted IBW

Medical Stability
Medical stability will be defined as the absence of any of the aforementioned indicators for a period of 72 hours.

Minimum Healthy Weight
Minimum healthy weight will be defined as reaching 90% of predicted IBW

Manualised Family-Based Treatment
Family-based treatment will be conducted using a three phase model as defined in “Treatment Manual for Anorexia Nervosa: A Family-Based Approach”. Each family will attend 20 one hour sessions, over a 12 month period. Family-based treatment will commence one week after discharge from hospital. The Maudsley Model of family treatment was developed by Dare and colleagues at the Maudsley hospital in London in the early 1980’s as an out-patient treatment for AN and was subsequently manualised by Lock and colleagues in the United States in 2002. The treatment is of one year duration and consists 20 one hour face to face therapy sessions grouped into three phases. Therapy sessions involve the young person with anorexia nervosa and all members of their family being seen by a family therapist. The model incoorporates aspects of structural and narrative therapy. In the first phase AN is externalised and parents mobilised to refeed their child in the home setting. Parents are seen as a central resource in the process of recovery and notions of familial aetiology are rejected. Siblings are allied with the patient to assist with distress arising as a result of parental control. Phase 1 consists of weekly family thearpy sessions for 12 weeks. Phase two is instigated once the child has reached 90% Ideal Body Weight (IBW) and a transition is made from parental to adolescent control of eating. Sessions during phase 2 are held fortnightly. Once full weight restoration and menstruation is achieved phase three commences which aims to assist the family to restart the normal adolescent life-cycle transition that has been stalled since the onset of the illness. Sessions during phase 3 are held on a monthly basis.
Intervention code [1] 1439 0
Treatment: Other
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 2219 0
The change in the core psychopathology of anorexia nervosa (AN)
Timepoint [1] 2219 0
There will be five major assessment points (imediately before treatment, 24 hours prior to discharge from hospital at the completion of hospital based treatment, at the completion of family therapy on the day of the final family therapy session and 6 and 12 months after the completion of treatment). The assessment will involve standardised research interviews and questionnaires, physical examination and clinical laboratory investigations. Psychological assessments will be conducted by a research assistant trained in their administration and scoring. This assistant will not be involved in patient treatment. Physical examination will be carried out by an experienced adolescent physician and clinical investigations will be carried through the Departments of Pathology and Radiology at The Children’s Hospital at Westmead.
Primary outcome [2] 2220 0
Change in weight as measured by percentage ideal body weight (%IBW).
Timepoint [2] 2220 0
There will be five major assessment points (imediately before treatment, 24 hours prior to discharge from hospital at the completion of hospital based treatment, at the completion of family therapy on the day of the final family therapy session and 6 and 12 months after the completion of treatment). The assessment will involve standardised research interviews and questionnaires, physical examination and clinical laboratory investigations. Psychological assessments will be conducted by a research assistant trained in their administration and scoring. This assistant will not be involved in patient treatment. Physical examination will be carried out by an experienced adolescent physician and clinical investigations will be carried through the Departments of Pathology and Radiology at The Children’s Hospital at Westmead.
Secondary outcome [1] 3873 0
Secondary measures will include rates of readmission, treatment completion, patient and family satisfaction with treatment, return to school and measures of self-esteem, depression and anxiety. Further measures of medical well-being will include menstrual status, measures of bone health and body composition measured by Dual X-Ray Absorptiometry (DXA), and hormonal levels.
Timepoint [1] 3873 0
There will be five major assessment points (imediately before treatment, 24 hours prior to discharge at the completion of hospital based treatment, at the completion of family therapy on the day of the finally family therapy session and 6 and 12 months after the completion of treatment).

Eligibility
Key inclusion criteria
Subjects will meet criteria for DSM-IV (Diagnostic and Statistical Manual of Mental Disorders 4th edition (DSM-IV)) AN, be medically unstable, have a duration of illness of less than 3 years. All subjects and their families will have provided informed consent prior to their inclusion in the study.
Minimum age
12 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Subjects will be excluded from the study if they show evidence of psychosis, mania, substance abuse, are currently engaged in psychotherapy or have significant current medical illnesses with the exception of nutrition related complications of AN.

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 Tamper Proof Envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised in clusters of using a fixed block size to receive one of two treatment regimens using a randomisation table created by computer sequence generation by The Clinical Epidemiology Unit at The Children’s Hospital, Westmead.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Therapists, assessor and data analyst will be blind to treatment allocation
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
4/06/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
72
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1754 0
Government body
Name [1] 1754 0
National Health and Medical Research Council
Country [1] 1754 0
Australia
Primary sponsor type
Hospital
Name
The Departments of Psychological Medicine and Adolescent Medicine at The Children's Hospital at Westmead and the Department of Adolescent Medicine at Westmead Hospital.
Address
The Children's Hospital at Westmead Locked Bag 4001 Westmead NSW 2145
Country
Australia
Secondary sponsor category [1] 1555 0
University
Name [1] 1555 0
The Department of Psychology, The University of Sydney
Address [1] 1555 0
School of Psychology
Brennan MacCallum Building (A18)
University of Sydney NSW 2006
Australia
Country [1] 1555 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3279 0
The Children's Hospital at Westmead
Ethics committee address [1] 3279 0
Ethics committee country [1] 3279 0
Australia
Date submitted for ethics approval [1] 3279 0
Approval date [1] 3279 0
20/12/2006
Ethics approval number [1] 3279 0
2006/114

Summary
Brief summary
Simple Description of the Project
This study examines the effect of length of hospital admission for refeeding, prior to manualised outpatient family therapy on outcomes for patients with AN. Subjects will include 72 children and adolescents aged 10 to 18 years admitted for medical management of AN of less than 3 years duration. This study aims to randomly allocate and compare outcomes between individuals with AN admitted for medical stabilisation, approximately 2 to 3 weeks, followed by 20 one hour sessions of outpatient family therapy over a 12 month period versus those admitted for full weight restoration, approximately 9 to 12 weeks also followed by 20 one hour sessions of outpatient family therapy. Physical and psychological outcomes will be measured at admission, at discharge from hospital, completion of outpatient treatment and at 6 and 12 months following outpatient treatment.
Interpretation of Results
If hospitalisation to a minimum healthy weight produces equivalent outcomes this has the potential to reduce the standard length of current hospital treatment for AN in adolescents from approximately 9 to 12 weeks to 2 to 3 weeks, resulting in benefits including savings of hospital based resources and reductions in the disruptions to schooling, peer and family relationships, adolescent development and family life. Should this not be the case this would support this would support the need for increased periods of hospitalisation with the possible benefits including reduced hospital readmission rates, decreased length of illness, decreased medical complications from malnutrition and lower levels of family and patient distress.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27373 0
Address 27373 0
Country 27373 0
Phone 27373 0
Fax 27373 0
Email 27373 0
Contact person for public queries
Name 10628 0
Jane Miskovic
Address 10628 0
The Children's Hospital at Westmead
Locked Bag 4001
Westmead NSW 2145
Country 10628 0
Australia
Phone 10628 0
+61 2 9845 1284
Fax 10628 0
+61 2 98452009
Email 10628 0
[email protected]
Contact person for scientific queries
Name 1556 0
Dr Sloane Madden
Address 1556 0
The Children's Hospital at Westmead
Locked Bag 4001
Westmead NSW 2145
Country 1556 0
Australia
Phone 1556 0
+61 2 98452005
Fax 1556 0
+61 2 98452009
Email 1556 0
[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
Current Study Results
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Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
4216Study results articleYes xxii. Madden S, Miskovic-Wheatley J, Wallis A, Koh... [More Details] 81684-(Uploaded-06-11-2018-12-52-51)-Journal results publication.pdf

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