Comparing CBT-T to CBT-E in Non-low-weight Adults With Eating Disorders

NCT03984539 | Unknown

• 1 other identifier: 6278
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Eating disorders are a difficult to treat illness with significant psychological and physical sequelae. Cognitive behavioural therapy (CBT) has been the most researched and supported intervention for eating disorders. A particular version of CBT for eating disorders, CBT-E (Fairburn, 2008), has been the focus of much research over the past decade. Despite promising results from initial CBT-E trials these findings have not always replicated well and evidence points to high drop-out in real-world settings. Further, CBT-E is a resource-intensive intervention, which may contribute to poorer access to care. In an attempt to overcome some of these barriers related to CBT-E, Waller and colleagues (2018) recently developed a brief (10 session) version of CBT for non-low-weight eating disorders (e.g., bulimia nervosa and binge eating disorder), referred to as CBT-T. Preliminary evidence from a case series of adult patients suggests that CBT-T has similar efficacy to CBT-E with low rates of drop-out. However, further evaluation of this brief treatment is needed, including direct comparisons with CBT-E. Indeed, given that no comparison group was included in the initial case series, it is unknown whether either CBT-T or CBT-E may be superior to the other. Thus, the aim of the current project is to examine CBT-T's efficacy in comparison to CBT-E as it has been implemented at the eating disorders service at London Health Science's Centre, and to determine whether either intervention is superior based on treatment outcome and treatment drop-out. Non-low-weight individuals with eating disorders assessed at the Adult Eating Disorders Service will be eligible to participate in the study. The principle investigator is Dr. Philip Masson, Ph.D., C. Psych., 519-685-8500 ext. 74866.

Conditions

Eating Disorders

Outcome Measures

Primary Outcomes (3)

• Change in the frequency of Binge Eating

  Assessed using EDE (Fairburn, Cooper, \& O'Connor, 2008) objective binge eating frequency for past month. Clients can answer anywhere from 0 binges to an infinite number of binges.

  Will be assessed Pre-Treatment; Post-Treatment (On average 10 weeks for CBT-T and 25 weeks for CBT-E), 3, 6, 12, 24 months post treatment. Treatment is on Average 10 weeks for CBT-T and 25 weeks for CBT-E

• Change in the frequency of Vomiting

  Assessed using EDE (Fairburn, Cooper, \& O'Connor, 2008) vomiting frequency for past month. Clients can answer anywhere from 0 vomiting episodes to an infinite number of vomiting episodes.

  Pre-Treatment; Post-Treatment (On average 10 weeks for CBT-T and 25 weeks for CBT-E) 3, 6, 12, 24 months post treatment. Treatment is on Average 10 weeks for CBT-T and 25 weeks for CBT-E

• Change in Eating Disorder Cognitions

  Assessed using EDE-Q (Fairburn \& Beglin, 2008) Global Score. Lowest possible global score is 0 and highest possible global score is 6. The higher the score the more severe the eating disorder cognitions.

  Pre-Treatment; Post-Treatment (On average 10 weeks for CBT-T and 25 weeks for CBT-E), 3, 6, 12, 24 months post treatment. Treatment is on Average 10 weeks for CBT-T and 25 weeks for CBT-E

Secondary Outcomes (9)

• Binge Eating Change over the Course of Treatment

  Pre-treatment and weekly while receiving treatment. Once a week for up to 10 weeks of treatment for CBT-T and up to 25 weeks of treatment for CBT-E.

• Vomiting Change over the Course of Treatment

  Pre-treatment and weekly while receiving treatment. Once a week for up to 10 weeks of treatment for CBT-T and up to 25 weeks of treatment for CBT-E.

• Working Alliance change over the Course of Treatment

  Pre-treatment and weekly while receiving treatment. Once a week for up to 10 weeks of treatment for CBT-T and up to 25 weeks of treatment for CBT-E.

• Change in Depression symptoms

  Pre-Treatment; Post-Treatment (On average 10 weeks for CBT-T and 25 weeks for CBT-E), 3, 6, 12, 24 months post treatment. Treatment is on Average 10 weeks for CBT-T and 25 weeks for CBT-E

• Change in anxiety symptoms

  Pre-Treatment; Post-Treatment (On average 10 weeks for CBT-T and 25 weeks for CBT-E), 3, 6, 12, 24 months post treatment. Treatment is on Average 10 weeks for CBT-T and 25 weeks for CBT-E

Study Arms (2)

CBT-E

ACTIVE COMPARATOR

Participants will be randomly assigned to one of two conditions (CBT-E or CBT-T). CBT-E will occur over the course of 25 weeks and be delivered as it typically is in the clinic setting of the investigators.

Behavioral: Cognitive Behavioural Therapy-Enhanced

CBT-T

EXPERIMENTAL

Participants will be randomly assigned to one of two conditions (CBT-E or CBT-T). Participants who agree to participate will receive 10 weeks of CBT-T.

Behavioral: Cognitive Behavioural Therapy-Ten

Interventions

Cognitive Behavioural Therapy-Enhanced BEHAVIORAL

CBT-E is a 20-session transdiagnostic eating disorders treatment based on the principles of cognitive behavioural therapy which has been developed over the past 40 years. The treatment focusses on tracking and modifying eating behaviours, providing psychoeducation, addressing overvaluation of weight and shape, body image, food restriction and restraint, emotion regulation, and relapse prevention.

CBT-E

Cognitive Behavioural Therapy-Ten BEHAVIORAL

CBT-T is a 10-session treatment based on cognitive behavioural therapy. It was developed based on clinical experience as well as core components of evidence-based versions of CBT for eating disorders, including CBT-E. The aim of the intervention is to provide only the hypothesized critical elements of CBT for eating disorders so that the interventions can be provided quicker.

CBT-T

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Non-underweight (BMI \> 19) adults (aged \> 17 years)
• Diagnosis of bulimia nervosa (BN), binge eating disorder (BED), or otherwise specified feeding or eating disorder (e.g., subthreshold BN, subthreshold BED, purging disorder)

You may not qualify if:

• Imminent risk for suicide
• Profound cognitive impairment
• Limited English language ability

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• University of Western Ontario, Canada: collaborator

Study Sites (1)

The Adult Eating Disorders Service

London, Ontario, N6J 1A2, Canada

RECRUITING

Related Publications (28)

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  BACKGROUND

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MeSH Terms

Conditions

Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Elizabeth Phoenix

  London Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elizabeth Phoenix, MScN

CONTACT

(519) 685-8500; Elizabeth.Phoenix@lhsc.on.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: At the beginning of client's appointments with the staff psychometrist, patients will be reminded of the study, provided information about the study and asked if to participate in the study. If interest is indicated, then the psychometrist will thoroughly review the letter of information with patients. If patients agree to participate and sign the consent form, study measures will be given. The psychometrist will then inform their assigned therapist that the client wishes to participate in the study. To ensure the psychometrist is not aware of randomization, Philip Masson (study PI) will randomize the client to one of the two interventions using the website random.org. Philip Masson will inform the therapist of the randomization, and the therapist will then proceed with the appropriate treatment intervention. The PI will then keep track of randomization assignment in a separate excel file that the psychometrist does not have access to.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is a randomized controlled trial comparing the efficacy of two outpatient psychological treatments for eating disorders that primarily differ in length. Investigators will use a longitudinal design that includes both interview and questionnaire measures to assess eating disorder symptoms and other mental health-related outcomes.

Study Record Dates

• First Submitted: May 29, 2019
• First Posted: June 13, 2019
• Study Start: June 15, 2021
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2023
• Last Updated: May 20, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)