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Trial registered on ANZCTR


Registration number
ACTRN12614000867695
Ethics application status
Approved
Date submitted
3/07/2014
Date registered
13/08/2014
Date last updated
21/05/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The use of patient symptom feedback to enhance therapy outcomes in a sample of eating disorder outpatients.
Scientific title
The use of patient symptom feedback to enhance therapy outcomes (remission and retention rates) in a sample of eating disorder outpatients.
Secondary ID [1] 284908 0
Nil
Universal Trial Number (UTN)
U1111-1158-7700
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Eating disorders 292373 0
Condition category
Condition code
Mental Health 292689 292689 0 0
Eating disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A clinical feedback tool that provides a trajectory of eating disorder symptomatology for both "good" and "poor" outcomes over the course of therapy. It will be implemented into a regime of enhanced CBT for individuals with eating disorders.

A subset of Eating Disorder Examination- Questionnaire (EDE-Q; Fairburn & Beglin, 2008) items will be administered at pre-treatment and every subsequent week during treatment. (duration 20-40 weeks). This brief questionnaire will take approximately 2-3 minutes to complete. The scores will be utilised by the clinician between sessions to monitor the patient's progress. This will enable the clinician to to examine whether clients are making reliable change in their questionnaire scores (and thus eating disorder psychopathology), and to monitor when clients are approaching, or have reached, a score indicative of reaching the "healthy" range.. Patients' individual progress will be monitored weekly by the clinician.
Intervention code [1] 289726 0
Treatment: Other
Comparator / control treatment
Use of a similar existing feedback tool that focuses on general process-based outcomes as opposed to specific eating disorder symptoms.

The Outcome Rating Scale (ORS; Miller et al., 2003) is a self-report, brief visual analogue measure, providing a measure of general patient progress in relation to overall wellbeing, and individual, interpersonal, and social wellbeing.

In the control group this questionnaire will be administered weekly over the course of treatment, (duration 20-40 weeks), and takes no more than 2-3 minutes to complete.
Control group
Active

Outcomes
Primary outcome [1] 292534 0
Change in eating disorder psychopathology over the course of treatment. To assess this, the EDE-Q global score will be used to assess change in eating disorder psychopathology over the course of treatment.
Timepoint [1] 292534 0
Pre and post-treatment, and at 5-session intervals over the course of treatment
Secondary outcome [1] 309164 0
Remission versus non-remission. Full Remission is defined as complete absence of eating disorder symptoms in the last 28 days, that is, 1) cessation of all key eating disorder behaviours, 2) BMI > or equal to 18.5, 3) not meeting the DSM criteria for an Eating Disorder Partial remission is defined as meeting all but 1 of the above criteria for full remission
Timepoint [1] 309164 0
End of treatment (post-treatment, at 20 weeks for patients with a BMI > 18.5, post-treatment at 40 weeks for patients with a BMI < 18.5)
Secondary outcome [2] 347113 0
Treatment completion versus drop out
Timepoint [2] 347113 0
End of treatment (post-treatment, at 20 weeks for patients with a BMI > 18.5, post-treatment at 40 weeks for patients with a BMI < 18.5)

Eligibility
Key inclusion criteria
Diagnosis of an eating disorder according to DSM 5
Minimum age
16 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
BMI < 14
Unsuitable for outpatient eating disorder treatment

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2016
Actual
1/05/2016
Date of last participant enrolment
Anticipated
Actual
19/07/2017
Date of last data collection
Anticipated
Actual
21/05/2018
Sample size
Target
140
Accrual to date
Final
56
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 289533 0
University
Name [1] 289533 0
University of Western Australia
Country [1] 289533 0
Australia
Primary sponsor type
University
Name
University of Western Australia
Address
Stirling Highway
Crawley, WA, 6009
Country
Australia
Secondary sponsor category [1] 288220 0
None
Name [1] 288220 0
Address [1] 288220 0
Country [1] 288220 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291274 0
West Australian Department of Health
Ethics committee address [1] 291274 0
Department of Health
189 Royal Street
East Perth WA 6004
Australia
Ethics committee country [1] 291274 0
Australia
Date submitted for ethics approval [1] 291274 0
14/08/2014
Approval date [1] 291274 0
Ethics approval number [1] 291274 0
Ethics committee name [2] 291279 0
University of Western Australia
Ethics committee address [2] 291279 0
Stirling Hwy
Crawley
WA
6009
Ethics committee country [2] 291279 0
Australia
Date submitted for ethics approval [2] 291279 0
23/07/2014
Approval date [2] 291279 0
03/02/2015
Ethics approval number [2] 291279 0
09_2014

Summary
Brief summary
Eating Disorders are a very serious illness with severe and psychiatric and health consequences. Current treatment outcomes are less than optimal, with room for improvement. Research is required to find out ways in which these outcomes can be improved.

Research has shown that the provision of patient progress feedback to clinicians can enhance therapy outcomes, although the body of literature into the provision of feedback within an eating disorder treatment setting is minimal. This study seeks to implement a symptom based clinical feedback tool into the course of eating disorder therapy, and compare it to an already established, more general, therapy process-based feedback tool.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 49630 0
A/Prof Sue Byrne
Address 49630 0
School of Psychology
The University of Western Australia (M304)
35 Stirling Highway
CRAWLEY WA 6009
Australia
Country 49630 0
Australia
Phone 49630 0
+61 (08) 6488 8079
Fax 49630 0
Email 49630 0
[email protected]
Contact person for public queries
Name 49631 0
A/Prof Sue Byrne
Address 49631 0
School of Psychology
The University of Western Australia (M304)
35 Stirling Highway
CRAWLEY WA 6009
Australia
Country 49631 0
Australia
Phone 49631 0
+61 (08) 6488 8079
Fax 49631 0
Email 49631 0
[email protected]
Contact person for scientific queries
Name 49632 0
A/Prof Sue Byrne
Address 49632 0
School of Psychology
The University of Western Australia (M304)
35 Stirling Highway
CRAWLEY WA 6009
Australia
Country 49632 0
Australia
Phone 49632 0
+61 (08) 6488 8079
Fax 49632 0
Email 49632 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
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Documents added automatically
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