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Comparing a Group-based Guided Self-help Approach to Pure Self-help for the Treatment of BED

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04432311
Recruitment Status : Not yet recruiting
First Posted : June 16, 2020
Last Update Posted : June 17, 2020
Sponsor:
Information provided by (Responsible Party):
Aaron Keshen, Nova Scotia Health Authority

Brief Summary:

Binge eating disorder (BED) is the most common eating disorder in adults, affecting 2.8% of the population. The disorder is characterized by recurrent episodes of binge eating which are not followed by inappropriate compensatory behaviours such as self-induced vomiting. BED is associated with an increased risk of health complications, significant impairment to social and occupational functioning, and reduced quality of life. Despite the negative consequences associated with this disorder, standard therapy for BED is often inaccessible and costly.

To address the limitations of standard therapy for BED our research team has developed Binge Focused Therapy (BFT) as an innovative, guided self-help approach to BED treatment. BFT was derived from elements of "The Brain Over Binge Recovery Guide" by Kathryn Hansen, which incorporates fundamental aspects of Acceptance and Commitment Therapy, Dialectical Behaviour Therapy, Motivational Enhancement Therapy, and addictions treatment. We further streamlined this approach into a protocol that can be delivered by non eating disorder specialists (e.g., honours psychology students, nurses, occupational therapists).

In 2018, our research team conducted a proof-of-concept pilot study with a sample of 40 individuals with BED. Unpublished results of this uncontrolled study indicated that the sample experienced significant reductions in binge episodes per month, binge eating severity, general eating disorder symptomology, and improved confidence in changing binge eating behaviours.

Although the results from this small, uncontrolled, proof-of-concept study are encouraging, qualitative and quantitative data highlighted several aspects of the BFT intervention that could be altered and tested in a randomized controlled trial that compares BFT to an active comparator.


Condition or disease Intervention/treatment Phase
Binge Eating Disorder Behavioral: Binge Focused Therapy (BFT) Behavioral: CBT Unguided Self Help (CBT USH) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 254 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial Comparing a Group-based Guided Self-help Approach to Pure Self-help for the Treatment of Binge Eating Disorder
Estimated Study Start Date : September 1, 2020
Estimated Primary Completion Date : December 1, 2021
Estimated Study Completion Date : December 1, 2021

Arm Intervention/treatment
Experimental: Binge Focused Therapy (BFT)
Guided self-help - Three online group sessions, homework, and self-guided check-ins to monitor continued progress and/or signs of relapse.
Behavioral: Binge Focused Therapy (BFT)
The BFT group will be provided Binge Focused Therapy, a group-based, guided-self help intervention. Participants in this group will attend three online group sessions spread over six weeks (Week 1, Week 2, and Week 6) and complete homework between sessions. Following Session 3, there is a four week period where participants complete self-guided check-ins once per week to monitor continued progress and/or signs of relapse.

Active Comparator: CBT Unguided Self Help (CBT USH)
Pure self-help - The use of the book Overcoming Binge Eating and its associated homework.
Behavioral: CBT Unguided Self Help (CBT USH)
The CBT USH group will be provided with the book, Overcoming Binge Eating by C. Fairburn, which is a well-established self-help book used to help individuals understand binge eating and control binge eating behaviours. After participants receive the book, they will have 10 weeks to read it and work through the exercises provided in the book.




Primary Outcome Measures :
  1. Binge Eating Symptomology [ Time Frame: Baseline to Post-Treatment (10 week) ]
    This will be measured using the global score generated from the Binge Eating Scale (BES). The BES is a 16-item measure, each item has 3-4 coded responses. The total score ranges from 0-46, where a higher score indicates greater binge eating severity.


Secondary Outcome Measures :
  1. Binge Eating Symptomology [ Time Frame: 6 week, 6-month follow-up, 12-month follow-up ]
    This will be measured using the global score generated from the Binge Eating Scale (BES). The BES is a 16-item measure, each item has 3-4 coded responses. The total score ranges from 0-46, where a higher score indicates greater binge eating severity.

  2. Binge Eating Frequency [ Time Frame: Baseline, 6 week, 10 week, 6-month follow-up, 12-month follow-up ]
    Self reported changes in Binge Eating Frequency over past 28 days will be measured using Item 15 from the Eating Disorder Examination Questionnaire 6.0 (EDE-Q; Fairburn & Beglin, 1994) which inquires about the number of days with objective binge episodes over the past 28 days.

  3. Eating Disorder Symptomology (Eating Disorder Examination Questionnaire) [ Time Frame: Baseline, 6 week, 10 week, 6-month follow-up, 12-month follow-up ]
    Self reported changes in Eating Disorder Symptomology will be measured using the global score generated from the EDE-Q (Fairburn & Beglin, 1994). The EDE-Q is a 28-item measure that assesses four areas of eating disorder psychopathology (eating concern, shape concern, weight concern, dietary restraint). Each item uses a Likert scale ranging from 0 (lowest frequency/severity) to 6 (highest frequency/severity). The global score ranges from 0-6 where higher scores indicate greater impairment. The global score is obtained using the mean of the four subscales.

  4. Clinical Impairment [ Time Frame: Baseline, 6 week, 10 week, 6-month follow-up, 12-month follow-up ]
    Self reported changes in clinical impairment will be measured using the Clinical Impairment Assessment Questionnaire (CIA; Bohn & Fairburn, 2008). This is a 16-item self-report measure of the severity of psychosocial impairment due to eating disorder features over the past 28 days. Each item is ranked on a 0-3 scale (0 being "not at all" and 3 being "a lot"). Total scores range from 0-48, with higher scores indicating greater clinical impairment.

  5. Confidence to Change Binge Eating [ Time Frame: Baseline, 6 week, 10 week, 6-month follow-up, 12-month follow-up ]
    Confidence to Change Binge Eating will be measured using the question, "On a scale from 1 to 10, how confident are you that you can change your binge eating if you wanted to?", with higher scores indicating greater confidence. This question assesses perceived confidence in ability to change binge eating.

  6. Abstinence [ Time Frame: Week 10, 6-month follow-up, 12-month follow-up ]
    Abstinence is defined as a 100% reduction in binge episodes in the 28 days prior to collecting outcome measures.

  7. Remission [ Time Frame: Week 10, 6-month follow-up, 12-month follow-up ]
    Remission is defined as meeting criteria for abstinence (100% reduction in binge episodes in the 28 days prior to collecting outcome measures) in addition to having EDEQ global score less than or equal to 2.77 (Fairburn & Beglin, 1994).

  8. Intervention Adherence [ Time Frame: Week 6, Week 10 ]

    Intervention adherence for participants in the BFT group will be based on session attendance. Completers will be defined as anyone who completes Session 1 and at least one other session. Adherence questionnaires at Week 6 and Week 10 time points inquire about which aspects of the intervention outside of the sessions have been used.

    Intervention adherence for participants in the CBT USH group will be calculated using questionnaires provided at both the Week 6 and Week 10 time points that inquire about which chapters have been read and which "CBT Steps" have been completed thus far. Completers will be defined as anyone who indicates that they have read Chapters 1, 4, 5, and 'Getting Ready', and completed Step 1 through Step 3.


  9. Participant Expectations [ Time Frame: Pre-Intervention, Week 1 ]
    This will be measured using the Credibility and Expectancy Questionnaire (CEQ; Devilly & Borkovec, 2000). The CEQ is a six item self-report measure that measures treatment expectancy and rationale credibility of therapeutic interventions. Each item is scored on a 1-9 Likert-type scale or as a percentage rating from 0% to 100% in increments of 10%. Higher scores indicate greater credibility/expectancy of the intervention.

  10. Satisfaction with Intervention [ Time Frame: Week 10 ]
    Participants in both groups will respond to developed Likert-style and open-ended questions asking about their perceptions of their assigned program. Each Likert item is ranked on a scale from 1-9. Higher total scores indicate greater satisfaction with the intervention.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Meets criteria for Diagnostic and Statistical Manual of Mental Disorders (5th Edition) diagnosis of BED (mild-extreme) as per Eating Disorder Examination - Mild severity will be modified from a minimum of 1 objective binge episode/week to 2 objective binge episodes per week
  • Age 18 or older
  • Access to computer with internet connection and webcam that can be used in a private area
  • Virtually signed information consent form

Exclusion Criteria:

  • Currently receiving psychotherapy/treatment for BED (as determined by PI)
  • Self-reported Body Mass Index on pre-screening questionnaire < 20 kg/m2
  • Dose change of a psychotropic medication used for the treatment of BED (e.g., Vyvanse, topiramate, antidepressants) within 4 weeks of study inclusion (as determined by PI)
  • Insufficient knowledge of English
  • Previously participated in proof-of-concept BFT study
  • Previously read Overcoming Binge Eating by C. Fairburn and implemented strategies presented in the book (as determined by PI)
  • Serious physical illness (e.g., severe uncontrolled insulin dependent diabetes) (as determined by PI)
  • Currently pregnant
  • Scores greater than 20 on the Quick Inventory of Depressive Symptomatology Self-Report and PI determines participant is significantly depressed (as determined by PI)
  • Currently experiencing serious issues with alcohol or drugs (as determined by PI)
  • Currently engaging in self-harm behaviours (as determined by PI)

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): NCT04432311


Contacts
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Contact: Aaron Keshen, MD, FRCPC (902) 473-6288 aaron.keshen@nshealth.ca

Locations
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Canada, Nova Scotia
Nova Scotia Heath Authority
Halifax, Nova Scotia, Canada, B3H 2E2
Contact: Aaron Keshen, MD    (902) 473-6288    aaron.keshen@nshealth.ca   
Sponsors and Collaborators
Nova Scotia Health Authority
Investigators
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Principal Investigator: Aaron Keshen, MD, FRCPC Nova Scotia Health Authority
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Responsible Party: Aaron Keshen, Psychiatrist, Principal Investigator, Nova Scotia Health Authority
ClinicalTrials.gov Identifier: NCT04432311    
Other Study ID Numbers: BFT 2.0
First Posted: June 16, 2020    Key Record Dates
Last Update Posted: June 17, 2020
Last Verified: June 2020
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
Keywords provided by Aaron Keshen, Nova Scotia Health Authority:
Binge Eating Disorder
Binge Focused Therapy (BFT)
Self-Help
Guided Self-Help
Additional relevant MeSH terms:
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Bulimia
Feeding and Eating Disorders
Binge-Eating Disorder
Mental Disorders
Hyperphagia
Signs and Symptoms, Digestive