Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001098527
Ethics application status
Approved
Date submitted
29/09/2015
Date registered
19/10/2015
Date last updated
6/03/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
10-session Cognitive Behavioural Therapy (CBT-T): Pilot study of a newer, shorter psychotherapy for the treatment of eating disorders
Scientific title
In clients with eating disorders, does CBT-T, compared with a wait-list control period, increase the rate of remission?
Secondary ID [1] 287566 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Eating Disorders 296347 0
Condition category
Condition code
Mental Health 296623 296623 0 0
Eating disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The aim of this research is to investigate a new treatment for eating disorders, a 10-session Cognitive Behavioural Therapy (CBT-T), formulated by Professor Glenn Waller in the United Kingdom, which is a shorter version of the current best psychological treatment targeting all eating disorders. CBT-T is an interview style psychotherapy which aims to identify and change unhelpful behaviours and thinking related to eating disorders. Participation involves being assessed on six occasions. On the first occasion this will involve an assessment appointment as well as completing a self-report questionnaire. You will then be given information to read from Glenn Waller’s book discussing getting ready for change. Four weeks after that you will be assessed again with the questionnaire and an interview and treatment will begin. The treatment will involve attending weekly face-to-face sessions of one hour duration for ten weeks, and experimenting with changing the way that you manage eating and mood. After the fourth session of CBT-T treatment you will be assessed for a third time with the questionnaire, and then again after the last session of treatment with the questionnaire and interview. You will be assessed a fifth time 4 weeks after the CBT-T treatment has finished, and again for a sixth and final time after another 8 weeks. Each assessment will take approximately 1.5 hours of your time. Therapists will be supervised provisional psychologists. Adherence will be monitored by registering attendance of CBT-T sessions and completion of assessments. GPs and other involved professionals will be corresponded with at the beginning and end of treatment to inform them of your progress or if you have withdrawn from the study.
Intervention code [1] 292968 0
Treatment: Other
Comparator / control treatment
Participants will each act as their own control. After the initial assessment there will be a 4 week period of no treatment prior to commencing CBT-T.
Control group
Active

Outcomes
Primary outcome [1] 296238 0
Eating disorder remission is the primary outcome. Remission will be defined as a score of less than one standard deviation away from community norms on the Eating Disorder Examination Questionnaire. In addition, remission will be defined as no bingeing, vomiting, or laxative abuse and a BMI of greater than or equal to 18.5 (the cut-off for healthy weight).
Timepoint [1] 296238 0
Remission will be specified when the above is met during the month prior to assessment. The criteria for remission will be assessed at baseline, immediately prior to treatment, after the fourth treatment session, after the last treatment session, 4 weeks post end of treatment and 12 weeks post end of treatment.
Secondary outcome [1] 317917 0
Eating disorder psychopathology as measured by the Eating Disorder Examination Questionaire (EDE-Q) and the 15-Item Eating Disorder Measure (ED15).
Timepoint [1] 317917 0
The EDE-Q will be assessed at baseline, immediately prior to treatment, after the fourth treatment session, after the last treatment session, 4 weeks post end of treatment and 12 weeks post end of treatment. The ED15 will be assessed at baseline, at all ten CBT-T sessions, 4 weeks post end of treatment and 12 weeks post end of treatment.
Secondary outcome [2] 317918 0
Psychosocial impairment due to eating disorder psychopathology as measured by the Clinical Impairment Assessment.
Timepoint [2] 317918 0
Assessed at baseline, immediately prior to treatment, after the fourth treatment session, after the last treatment session, 4 weeks post end of treatment and 12 weeks post end of treatment.
Secondary outcome [3] 317919 0
General psychopathology as measured by the Depression Anxiety and Stress Scales 21 and the Outcome Rating Scale.
Timepoint [3] 317919 0
Assessed at baseline, immediately prior to treatment, after the fourth treatment session, after the last treatment session, 4 weeks post end of treatment and 12 weeks post end of treatment.
Secondary outcome [4] 317920 0
Quality of therapeutic alliance as measured by the Working Alliance Inventory - Short Revised (WAI-SR) and the Session Rating Scale (SRS)
Timepoint [4] 317920 0
The WAI-SR will be assessed at the first treatment session, after the fourth treatment session, after the seventh treatment session, after the last treatment session, 4 weeks post end of treatment and 12 weeks post end of treatment. The SRS will be assessed at all CBT-T treatment sessions.
Secondary outcome [5] 317921 0
Motivation as measured using two 10-point Likert scales.
Timepoint [5] 317921 0
Motivation will be assessed at baseline, immediately prior to treatment, after the fourth treatment session, after the last treatment session, 4 weeks post end of treatment and 12 weeks post end of treatment.
Secondary outcome [6] 317922 0
Body image as measured by the Body Image Acceptance and Action Questionnaire, the Body Checking Questionnaire, and the Body Image Avoidance Questionnaire.
Timepoint [6] 317922 0
Assessed at baseline, immediately prior to treatment, after the fourth treatment session, after the last treatment session, 4 weeks post end of treatment and 12 weeks post end of treatment.
Secondary outcome [7] 317923 0
Perfectionism as measured by the Multidimensional Perfectionism Scale.
Timepoint [7] 317923 0
Assessed at baseline, immediately prior to treatment, after the fourth treatment session, after the last treatment session, 4 weeks post end of treatment and 12 weeks post end of treatment.
Secondary outcome [8] 317924 0
Self-compassion as measured by the Fears of Compassion Scales and the Forms of Self-Criticising/Attacking and Self-Reassuring Scales.
Timepoint [8] 317924 0
Assessed at baseline, immediately prior to treatment, after the fourth treatment session, after the last treatment session, 4 weeks post end of treatment and 12 weeks post end of treatment.
Secondary outcome [9] 317926 0
Personality traits related to psychopathology as measured by the Personality Beliefs Questionnaire.
Timepoint [9] 317926 0
Assessed at baseline only.
Secondary outcome [10] 317927 0
DSM-IV Axis 1 disorders as measured by the MINI International Neuropsychiatric Interview.
Timepoint [10] 317927 0
Administered at treatment sessions 1 and 10.
Secondary outcome [11] 318289 0
Weight
Timepoint [11] 318289 0
Weight will be assessed at baseline, at all ten CBT-T sessions, 4 weeks post end of treatment and 12 weeks post end of treatment.
Secondary outcome [12] 318290 0
BMI
Timepoint [12] 318290 0
BMI will be calculated at baseline, at all ten CBT-T sessions, 4 weeks post end of treatment and 12 weeks post end of treatment.

Eligibility
Key inclusion criteria
Have a BMI greater than 17.5, be willing for their therapist to communicate with GP and other treating professionals, and meet DSM-5 critieria for Anorexia Nervosa (AN), Bulimia Nervosa (BN), Binge Eating Disorder (BED), or Other Specified Feeding and Eating Disorders (OSFED).
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Severe physical and/or psychiatric conditions that would interfere with treatment (e.g. high suicidality, active psychosis, if already receiving psychotherapy for an eating disorder, or if difficulty speaking or understanding English.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
26/05/2015
Date of last participant enrolment
Anticipated
14/04/2017
Actual
31/03/2017
Date of last data collection
Anticipated
14/10/2017
Actual
14/10/2017
Sample size
Target
30
Accrual to date
Final
105
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 292131 0
University
Name [1] 292131 0
Flinders University
Country [1] 292131 0
Australia
Primary sponsor type
Individual
Name
Mia Pellizzer
Address
Flinders University
School of Psychology
Sturt Road
Bedford Park SA 5042
Country
Australia
Secondary sponsor category [1] 290808 0
Individual
Name [1] 290808 0
Prof Tracey Wade
Address [1] 290808 0
Flinders University
School of Psychology
Sturt Road
Bedford Park SA 5042
Country [1] 290808 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293611 0
Southern Adelaide Clinical Human Research Ethics Comittee
Ethics committee address [1] 293611 0
Ethics committee country [1] 293611 0
Australia
Date submitted for ethics approval [1] 293611 0
Approval date [1] 293611 0
07/07/2015
Ethics approval number [1] 293611 0
204.15

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

Contacts
Principal investigator
Name 60678 0
Ms Mia Pellizzer
Address 60678 0
Flinders University
School of Psychology
Bedford Park SA 5042
Country 60678 0
Australia
Phone 60678 0
+61 8 8201 7993
Fax 60678 0
Email 60678 0
[email protected]
Contact person for public queries
Name 60679 0
Mia Pellizzer
Address 60679 0
Flinders University
School of Psychology
Bedford Park SA 5042
Country 60679 0
Australia
Phone 60679 0
+61 8 8201 7993
Fax 60679 0
Email 60679 0
[email protected]
Contact person for scientific queries
Name 60680 0
Mia Pellizzer
Address 60680 0
Flinders University
School of Psychology
Bedford Park SA 5042
Country 60680 0
Australia
Phone 60680 0
+61 8 8201 7993
Fax 60680 0
Email 60680 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
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseA randomized controlled trial of unguided internet cognitive behaviour therapy for perfectionism in adolescents: Impact on risk for eating disorders.2019https://dx.doi.org/10.1016/j.brat.2019.103429
EmbasePredictors of outcome in cognitive behavioural therapy for eating disorders: An exploratory study.2019https://dx.doi.org/10.1016/j.brat.2019.02.005
N.B. These documents automatically identified may not have been verified by the study sponsor.