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

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ClinicalTrials.gov Identifier: NCT03984539
Recruitment Status : Not yet recruiting
First Posted : June 13, 2019
Last Update Posted : July 8, 2019
Sponsor:
Collaborator:
University of Western Ontario, Canada
Information provided by (Responsible Party):
Lawson Health Research Institute

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.

Condition or disease Intervention/treatment Phase
Eating Disorders Behavioral: Cognitive Behavioural Therapy-Enhanced Behavioral: Cognitive Behavioural Therapy-Ten Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: Single (Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of the Effectiveness of CBT-T vs CBT-E in a Community Clinic of Individuals With Eating Disorders
Estimated Study Start Date : January 1, 2020
Estimated Primary Completion Date : January 1, 2023
Estimated Study Completion Date : January 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eating Disorders

Arm Intervention/treatment
Active Comparator: CBT-E
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-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.

Experimental: CBT-T
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
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.




Primary Outcome Measures :
  1. Change in the frequency of Binge Eating [ Time Frame: Will be assed 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 ]
    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.

  2. Change in the frequency of Vomiting [ Time Frame: 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 ]
    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.

  3. Change in Eating Disorder Cognitions [ Time Frame: 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 ]
    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.


Secondary Outcome Measures :
  1. Binge Eating Change over the Course of Treatment [ Time Frame: Pre-treatment and weekly while recieving treatment. Once a week for up to 10 weeks of treatment for CBT-T and up to 25 weeks of treatment for CBT-E. ]
    Binge eating symptoms recorded weekly via the Eating Disorder-15 (Tatham et al., 2015). Clients will indicate frequency of binging on this measure. The higher the number the more often clients are binging. Binge eating frequency is not part of a scale rather, the number indicated represents the number of binges clients report having.

  2. Vomiting Change over the Course of Treatment [ Time Frame: Pre-treatment and weekly while recieving 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 symptoms recorded weekly via the Eating Disorder-15 (Tatham et al., 2015). The higher the number the more often clients are vomiting. Vomiting frequency is not part of a scale rather, the number indicated represents the number of vomiting episodes clients report having.

  3. Working Alliance change over the Course of Treatment [ Time Frame: Pre-treatment and weekly while recieving 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 as measured by the Working Alliance Short-Form (Hatcher & Gillaspy, 2006). Each item is rated on a 1-7 scale, where 1 = 'Not at all', and 7 = 'Completely'. The highest possible score is 84 and the lowest possible score is 12. The higher the score the better working alliance towards therapist and client.

  4. Change in Depression symptoms [ Time Frame: 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 ]
    Assess via the Patient Health Questionnaire (PHQ-9; Kroenke, Spitzer, & Williams, 2001). The highest possible score is 27 and the lowest possible score is 0. The lower the score the less depression symptoms.

  5. Change in anxiety symptoms [ Time Frame: 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 ]
    Assess via the Generalized Anxiety Disorder Questionnaire (Spitzer, Kroenke, Williams, & Lowe, 2006). The highest possible score is 21 and the lowest possible score is 0. The lower the score the less anxiety symptoms.

  6. Change in Loss of Control over Eating [ Time Frame: 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 ]
    Assessed using the Loss of Control over Eating Scale-Brief (LOCES-B; Latner et al., 2014). The brief version of the LOCES is a 7-item measure used to assess severity of loss of control over eating. Example items include "I continued to eat past the point when I wanted to stop" and "I felt I could not do anything other than eat." Items are scored on 5-point Likert scale ranging from 1=never to 5=Always. 7 is the lowest possible score and 35 is the highest possible score. The lower the score the better as this indicates better control over eating. The higher the score the worse as this indicates the inability to control eating.

  7. Change in Motivation [ Time Frame: 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 ]
    Assessed via the Readiness and Motivation Questionnaire (Geller et al., 2013). Overall scores can be calculated to determine precontemplation, action, internality, and confidence for changing symptoms. Scores range from 0% to 100%, where higher scores indicate more of the construct.

  8. Change in Impulsivity [ Time Frame: 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 ]
    Assessed via the the negative urgency scale (from the full version of the UPPS-P). Ranges from 1 strongly agree, 2 somewhat agree, 3 Disagree and 4 Disagree Strongly. 12 is the lowest possible score and 44 is the highest possible score. The lower the score the better as this indicates less impulsivity. The higher the score the worse, as this indicates high impulsivity.

  9. Change in overall perceived quality of life [ Time Frame: 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 ]
    Assessed via the world health organization quality of life scale-brief (WHOQOL-BREF). The WHOQOL-BREF produces a quality of life profile. It is possible to derive 4 domains. 2 items are examined separately- question 1 asks about an individuals overall perception of quality of life and question 2 asks about an individuals overall perception of their health. The 4 domain scores denote an individuals perception of quality of life in each particular domain. Domain scores are scaled in a positive direction (higher scores denote higher quality of life). The mean score of items within each domain is used to calculate the domain score. Mean scores are then multiplied by 4 in order to make domain scores comparable with the scores in the WHOQOL-100 (full version of the scale).



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Ages Eligible for Study:   17 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Imminent risk for suicide
  2. Profound cognitive impairment
  3. Limited English language ability

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03984539


Contacts
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Contact: Philip Masson, Dr. (519) 685-8500 ext 74866 Philip.Masson@lhsc.on.ca

Sponsors and Collaborators
Lawson Health Research Institute
University of Western Ontario, Canada
Investigators
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Principal Investigator: Philip Masson, Dr. London Health Sciences Centre

Publications:
Butler, A. C., Beck, A. T., & Cohen, L. H. (2007). The personality belief questionnaire-short form: Development and preliminary findings. Cognitive Therapy and Research, 31, 357-370. http://dx.doi.org/10.1007/s10608-006-9041-x
Fairburn, C. G. (2008). Cognitive behavior therapy and eating disorders. New York, NY: Guilford.
Fairburn, C. G., & Beglin, S. J. (2008) Eating Disorder Examination Questionnaire (6.0). In Fairburn CG. Cognitive Behavior Therapy and Eating Disorders. New York: Guilford Press.
Fairburn, C. G., Cooper, Z., & O'Connor, M. (2008). Eating Disorder Examination (16.0D). In Fairburn C. G., Cognitive Behavior Therapy and Eating Disorders. New York: Guilford Press.
Hatcher, R. L., & Gillaspy, J. A. (2006). Development and validation of a revised short version of the working alliance inventory. Psychotherapy Research, 16, 12-25. http://dx.doi.org/10.1080/10503300500352500
Newman, M., Zuellig, A. R., Kachin, K. E., Constanitno, M. J., Przeworski, A., Erickson, T., & Cashman-McGrath, L. (2002). Preliminary reliability and validity of the generalized anxiety disorder questionnaire-IV: A revised self-report diagnostic measure of generalized anxiety disorder. Behavior Therapy, 33, 215-233. https://doi.org/10.1016/S0005-7894(02)80026-0
National Institute of Clinical Excellence. (2017). Eating disorders: Recognition and Treatment. NICE Guideline (NG69)
Rounsaville BJ, Carroll KM, Onken LS. A stage model of behavioral therapies research: Getting started and moving on from stage I. Clinical Psychology: Science and Practice. 2001;8(2):133-142.

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Responsible Party: Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT03984539     History of Changes
Other Study ID Numbers: 6278
First Posted: June 13, 2019    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Disease
Feeding and Eating Disorders
Pathologic Processes
Mental Disorders