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Trial registered on ANZCTR


Registration number
ACTRN12613000183785
Ethics application status
Approved
Date submitted
13/02/2013
Date registered
15/02/2013
Date last updated
24/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Group Enhanced Cognitive Behaviour Therapy (CBT-E) for Eating Disorders
Scientific title
A randomised controlled trial of group Enhanced Cognitive Behaviour Therapy (CBT-E) versus a waitlist control condition for adult women with eating disorders: Outcomes for eating disorder symptoms and perfectionism, low self-esteem, mood intolerance and interpersonal difficulties
Secondary ID [1] 281953 0
None.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Eating disorders 288371 0
Condition category
Condition code
Mental Health 288716 288716 0 0
Eating disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Enhanced cognitive behavioural therapy (CBT-E) is a psychological treatment that is suitable for use with all forms of eating disorders. The treatment focuses on addressing the behaviours, emotions, thoughts and beliefs associated with eating disorders. The treatment also addresses additional mechanisms that, for some, act as a barrier for change and maintain eating disorder symptoms.

In this trial, the intervention will consist of group CBT-E delivered on an outpatient basis. Groups will run once per week for 2 hours, over a 20 week period. Approximately 10 adult women will take part in each group, and groups will be led by 2 facilitators. Individual research assessments will be scheduled pre-treatment, mid-treatment, post-treatment and at 3-months post-treatment follow-up.

The research assessments will involve completing a series of self-report questionnaires regarding depressive, anxiety and stress symptoms (the Depression Anxiety Stress Scale); perfectionism (the Clinical Perfectionism Questionnaire); self-esteem (the Rosenberg Self-Esteem Scale); self-efficacy (General Perceived Self-Efficacy Scale); relationship difficulties (Inventory of Interpersonal Problems); problems with tolerating emotions (Distress Tolerance Scale and Tolerance of Mood States Scale); problems with tolerating uncertainty (Intolerance of Uncertainty Scale); repetitive thinking (Repetitive Thinking Questionnaire); quality of life (Quality of Life and Satisfaction Questionnaire); the tendency to think in 'all of nothing' terms (Dichotomous Thinking Scale); goal setting (Conditional Goal Setting); personality traits (Screening Test for Comorbid Personality Disorders); body image (Body Image Concern Inventory); and eating disorder symptoms (Eating Disorder Examination-Questionnaire).

These self-report questionnaires may be completed in participant's own time if preferred, and should take approximately 30 minutes at each assessment point.

At pre-treatment only, the research assessment will also include an individual clinical interview with a psychologist. This interview will cover general background information, current eating disorder symptoms (assessed using the Eating Disorder Examination, a semi-structured interview), and other psychological difficulties (assessed using the MINI Neuropsychiatric Interview, a semi-structured interview). Height and weight will be measured. This assessment will last approximately 90 minutes.
Intervention code [1] 286516 0
Treatment: Other
Intervention code [2] 286517 0
Behaviour
Comparator / control treatment
A waitlist control condition will be used. Participants randomised to waitlist control will have a wait of 8 weeks before commencing treatment. They will attend a research assessment before and after the waitlist period. After the waitlist period, they will commence group CBT-E following the same protocols as outlined for the intervention group. Thus, they will receive 20 weeks of group treatment with follow-up research assessments at mid-treatment, post-treatment and 3-months post-treatment.

The research assessments will involve completing a series of self-report questionnaires regarding depressive, anxiety and stress symptoms (the Depression Anxiety Stress Scale); perfectionism (the Clinical Perfectionism Questionnaire); self-esteem (the Rosenberg Self-Esteem Scale); self-efficacy (General Perceived Self-Efficacy Scale); relationship difficulties (Inventory of Interpersonal Problems); problems with tolerating emotions (Distress Tolerance Scale and Tolerance of Mood States Scale); problems with tolerating uncertainty (Intolerance of Uncertainty Scale); repetitive thinking (Repetitive Thinking Questionnaire); quality of life (Quality of Life and Satisfaction Questionnaire); the tendency to think in 'all of nothing' terms (Dichotomous Thinking Scale); goal setting (Conditional Goal Setting); personality traits (Screening Test for Comorbid Personality Disorders); body image (Body Image Concern Inventory); and eating disorder symptoms (Eating Disorder Examination-Questionnaire).

These self-report questionnaires may be completed in participant's own time if preferred, and should take approximately 30 minutes at each assessment point.

At the initial assessment, before randomisation to the 8 week waiting period, the research assessment will also include an individual clinical interview with a psychologist. This interview will cover general background information, current eating disorder symptoms (assessed using the Eating Disorder Examination, a semi-structured interview), and other psychological difficulties (assessed using the MINI Neuropsychiatric Interview, a semi-structured interview). Height and weight will be measured. This assessment will last approximately 90 minutes.
Control group
Active

Outcomes
Primary outcome [1] 288858 0
Presence of binge eating and purging symptoms. These will be assessed using the items regarding frequency of binge eating episodes (eating a large amount of food with the experience of loss of control over eating) and frequency of purging episodes (self-induced vomiting and/or laxative misuse) on the Eating Disorder Examination-Questionnaire. Participants will self-complete the Eating Disorder Examination-Questionnaire at each of the research assessment points.
Timepoint [1] 288858 0
Baseline (assessment), 8 weeks after assessment, post-treatment and at 3-months post-treatment follow-up.
Primary outcome [2] 288859 0
Mean Eating Disorder Examination-Questionnaire score.
Timepoint [2] 288859 0
Baseline (assessment), 8 weeks after assessment, post-treatment and at 3-months post-treatment follow-up.
Secondary outcome [1] 301178 0
Mean Clinical Perfectionism Questionnaire score.
Timepoint [1] 301178 0
Baseline (assessment), 8 weeks after assessment, post-treatment and at 3-months post-treatment follow-up.
Secondary outcome [2] 301179 0
Mean Rosenberg Self-Esteem Scale score.
Timepoint [2] 301179 0
Baseline (assessment), 8 weeks after assessment, post-treatment and at 3-months post-treatment follow-up.
Secondary outcome [3] 301180 0
Mean Tolerance of Mood States Scale score.
Timepoint [3] 301180 0
Baseline (assessment), 8 weeks after assessment, post-treatment and at 3-months post-treatment follow-up.
Secondary outcome [4] 301181 0
Mean Inventory of Interpersonal Problems score.
Timepoint [4] 301181 0
Baseline (assessment), 8 weeks after assessment, post-treatment and at 3-months post-treatment follow-up.

Eligibility
Key inclusion criteria
Inclusion criteria are being female; aged 18 years or older; meeting DSM-5 criteria for an eating disorder; having a Body Mass Index >18.5 and <30 (healthy weight or overweight); and having no other medical or psychiatric difficulties requiring urgent attention.

Addtionally, all participants will provide informed consent and will be required to have their physical health monitored by a General Practitioner for the duration of group treatment and must not be involved in any other concurrent eating disorder treatments.
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria are being medically compromised (as determined by medical doctor); having a Body Mass Index (BMI) that indicates underweight (BMI <18.5) or obesity (BMI >30); being at risk of suicide (assessed during pre-treatment clinical assessment); the presence of severe psychological comorbidity that requires more immediate treatment; or inability to attend the full duration of 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
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)
WA

Funding & Sponsors
Funding source category [1] 286731 0
University
Name [1] 286731 0
University of Western Australia
Address [1] 286731 0
UWA
35 Stirling Hwy
Crawley
WA Australia 6009
Country [1] 286731 0
Australia
Primary sponsor type
Individual
Name
Dr Karina Allen
Address
School of Psychology M304
UWA
35 Stirling Hwy
Crawley
WA Australia 6009
Country
Australia
Secondary sponsor category [1] 285506 0
Individual
Name [1] 285506 0
Stephanie Wade
Address [1] 285506 0
School of Psychology M304
UWA
35 Stirling Hwy
Crawley
WA Australia 6009
Country [1] 285506 0
Australia
Secondary sponsor category [2] 285507 0
Individual
Name [2] 285507 0
Associate Professor Sue Byrne
Address [2] 285507 0
School of Psychology M304
UWA
35 Stirling Hwy
Crawley
WA Australia 6009
Country [2] 285507 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288803 0
University of Western Australia Human Research Ethics Committee
Ethics committee address [1] 288803 0
UWA Human Research Ethics Committee
35 Stirling Hwy
Crawley
WA Australia 6009
Ethics committee country [1] 288803 0
Australia
Date submitted for ethics approval [1] 288803 0
18/01/2013
Approval date [1] 288803 0
01/04/2013
Ethics approval number [1] 288803 0
Ethics committee name [2] 288804 0
North Metropolitan Health Service Research Ethics and Governance Office
Ethics committee address [2] 288804 0
Secretary
Human Research Ethics Committee
Graylands Hospital
Locked Bag No. 1
PO CLAREMONT WA 6910
Ethics committee country [2] 288804 0
Australia
Date submitted for ethics approval [2] 288804 0
08/02/2013
Approval date [2] 288804 0
Ethics approval number [2] 288804 0

Summary
Brief summary
This study aims to evaluate the efficacy of group Enhanced Cognitive Behaviour Therapy (CBT-E) for eating disorders in adults. It is hypothesised that, on average, group CBT-E will result in significant pre- to post-treatment improvements in eating disorder symptoms and in symptoms relating to perfectionism, low self-esteem, mood intolerance and interpersonal problems. It is also hypothesised that group CBT-E will be significantly more effective than a waitlist control condition in producing changes in symptoms.
Trial website
Trial related presentations / publications
Public notes
The proposed project timeline outlined that final data collection would occur 32 weeks after the date of last participant enrollment. To fit with final timelines there were some participants who had their finial data collection 30 weeks after enrollment.

Contacts
Principal investigator
Name 37850 0
Dr Karina Allen
Address 37850 0
School of Psychology, M304
The University of Western Australia
35 Stirling Hwy
Crawley
WA Australia 6009
Country 37850 0
Australia
Phone 37850 0
+61 8 6499 7428
Fax 37850 0
Email 37850 0
karina.allen@uwa.edu.au
Contact person for public queries
Name 37851 0
Miss Stephanie Wade
Address 37851 0
School of Psychology, M304
The University of Western Australia
35 Stirling Hwy
Crawley
WA Australia 6009
Country 37851 0
Australia
Phone 37851 0
+61 8 6488 1419
Fax 37851 0
Email 37851 0
20167468@student.uwa.edu.au
Contact person for scientific queries
Name 37852 0
Dr Karina Allen
Address 37852 0
School of Psychology, M304
The University of Western Australia
35 Stirling Hwy
Crawley
WA Australia 6009
Country 37852 0
Australia
Phone 37852 0
+61 8 6499 7428
Fax 37852 0
Email 37852 0
karina.allen@uwa.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