Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000111875
Ethics application status
Approved
Date submitted
8/12/2020
Date registered
4/02/2021
Date last updated
4/02/2021
Date data sharing statement initially provided
4/02/2021
Date results provided
4/02/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
STED: Shorter therapies for non-underweight Eating Disorders
Scientific title
Comparison of two 10-session cognitive behaviour therapies for non-underweight eating disorders on symptom severity: A randomised controlled trial
Secondary ID [1] 302975 0
None
Universal Trial Number (UTN)
U1111-1262-4919
Trial acronym
STED
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-underweight eating disorders 320027 0
Condition category
Condition code
Mental Health 317949 317949 0 0
Eating disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Two ten session face-to-face cognitive behaviour therapies for non-underweight eating disorders delivered over 10 consecutive weeks were compared. The first was Ten-session cognitive behaviour therapy (CBT-T), using the protocol outlined in Waller G, Turner H, Tatham M, Mountford VA, Wade TD. (2019). Brief Cognitive Behavioural Therapy for Non-Underweight Patients: CBT-T for Eating Disorders. Abingdon: Routledge, Taylor & Francis Group. The second was CBT using guided self-help (GSH) based primarily on the self-help books Cooper, P. (2009). Overcoming Bulimia Nervosa and Binge Eating (3rd ed). London, UK: Little, Brown Book Group and Cooper, M., Todd, G., & Wells, A. (2001). Bulimia Nervosa: A Cognitive Therapy Programme for Clients. London, UK: Jessica Kingsley Publisher Ltd. Both were delivered by postgraduate trainee therapists. Both therapies are conducted weekly over 10 weeks (50 minute sessions) and both address eating diaries to promote regular eating and to connect in-session weighing to changes in eating. The CBT-T addresses changes to eating more quickly than GSH and also includes content on body image. The GSH includes several initial sessions on motivation. The number of sessions attended was recorded.
Intervention code [1] 319262 0
Treatment: Other
Comparator / control treatment
CBT-T was compared to a "reference comparatory" intervention (GSH).
Control group
Active

Outcomes
Primary outcome [1] 325958 0
The global score on the Eating Disorder Examination Questionnaire
Timepoint [1] 325958 0
10 weeks following start of intervention
Secondary outcome [1] 390332 0
Eating disorder behaviours: EDE-Q
Timepoint [1] 390332 0
10 weeks following start of intervention
Secondary outcome [2] 390333 0
Body mass index - height and weight assessed in session by therapist using digital scales and stadiometer
Timepoint [2] 390333 0
10 weeks following start of intervention
Secondary outcome [3] 390334 0
The Body Image Acceptance and Action Questionnaire
Timepoint [3] 390334 0
10 weeks following start of intervention
Secondary outcome [4] 390335 0
Body Image Avoidance Questionnaire
Timepoint [4] 390335 0
10 weeks following start of intervention
Secondary outcome [5] 390336 0
Body Checking Questionnaire
Timepoint [5] 390336 0
10 weeks following start of intervention
Secondary outcome [6] 390337 0
Negative Affect (depression, anxiety and stress): DASS21
Timepoint [6] 390337 0
10 weeks following start of intervention
Secondary outcome [7] 390338 0
Clinical impairment: Clinical Impairment Assessment
Timepoint [7] 390338 0
10 weeks following start of intervention

Eligibility
Key inclusion criteria
1. Be at least 16 years in age
2. Have a body mass index (BMI) more than 17.5,
3. Meet DSM-5 criteria for an eating disorder
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. A severe physical/ psychiatric condition that would hinder treatment (e.g., psychosis, substance dependence)
2. Those already engaged with psychological treatment for an eating disorder
3. Difficulty speaking English

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)
Allocation was concealed using sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Linear mixed models including all participants randomized to the two treatment groups.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
5/06/2017
Date of last participant enrolment
Anticipated
Actual
30/04/2020
Date of last data collection
Anticipated
Actual
9/11/2020
Sample size
Target
100
Accrual to date
Final
98
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 307391 0
Commercial sector/Industry
Name [1] 307391 0
Australian Psychological Society - Clinical College
Country [1] 307391 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
GPO Box 2100, Adelaide, 5001, SA
Country
Australia
Secondary sponsor category [1] 308049 0
University
Name [1] 308049 0
Sheffield University
Address [1] 308049 0
Western Bank
Sheffield
S10 2TN
UK
Country [1] 308049 0
United Kingdom

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307478 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 307478 0
Ethics committee country [1] 307478 0
Australia
Date submitted for ethics approval [1] 307478 0
05/05/2015
Approval date [1] 307478 0
07/07/2015
Ethics approval number [1] 307478 0
204.15

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

Contacts
Principal investigator
Name 107370 0
Prof Tracey Wade
Address 107370 0
Flinders University, GPO Box 2100, Adelaide, SA, 5001, Australia
Country 107370 0
Australia
Phone 107370 0
+61882013736
Fax 107370 0
+61882013877
Email 107370 0
[email protected]
Contact person for public queries
Name 107371 0
Tracey Wade
Address 107371 0
Flinders University, GPO Box 2100, Adelaide, SA, 5001, Australia
Country 107371 0
Australia
Phone 107371 0
+61882013736
Fax 107371 0
+61882013877
Email 107371 0
[email protected]
Contact person for scientific queries
Name 107372 0
Tracey Wade
Address 107372 0
Flinders University, GPO Box 2100, Adelaide, SA, 5001, Australia
Country 107372 0
Australia
Phone 107372 0
+61882013736
Fax 107372 0
+61882013877
Email 107372 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
after de-identification; individual participant data underlying published results only
When will data be available (start and end dates)?
After publication of the results for a maximum of 5 years
Available to whom?
Any reasonable requests directed to Tracey Wade
Available for what types of analyses?
Meta-analyses
How or where can data be obtained?
Request to Tracey Wade, [email protected]


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
EmbaseA randomized controlled trial of two 10-session cognitive behaviour therapies for eating disorders: An exploratory investigation of which approach works best for whom.2021https://dx.doi.org/10.1016/j.brat.2021.103962
N.B. These documents automatically identified may not have been verified by the study sponsor.