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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]

None.

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Eating disorders

Condition category

Condition code

Mental Health

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]

Treatment: Other

Intervention code [2]

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]

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]