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

Primary Purpose

Binge Eating Disorder

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Binge Focused Therapy (BFT)
CBT Unguided Self Help (CBT USH)
Sponsored by
Nova Scotia Health Authority
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Binge Eating Disorder focused on measuring Binge Eating Disorder, Binge Focused Therapy (BFT), Self-Help, Guided Self-Help

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 informed 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) or any medication that could have an effect on appetite/binging (e.g., Saxenda) 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)

Sites / Locations

  • Nova Scotia Heath Authority

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Binge Focused Therapy (BFT)

CBT Unguided Self Help (CBT USH)

Arm Description

Guided self-help - Three online group sessions, homework, and self-guided check-ins to monitor continued progress and/or signs of relapse.

Pure self-help - The use of the book Overcoming Binge Eating and its associated homework.

Outcomes

Primary Outcome Measures

Binge Eating Symptomology
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

Binge Eating Symptomology
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.
Binge Eating Frequency
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.
Eating Disorder Symptomology (Eating Disorder Examination Questionnaire)
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.
Clinical Impairment
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.
Confidence to Change Binge Eating
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.
Abstinence
Abstinence is defined as a 100% reduction in binge episodes in the 28 days prior to collecting outcome measures.
Remission
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).
Intervention Adherence
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.
Participant Expectations
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.
Satisfaction with Intervention
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.

Full Information

First Posted
June 11, 2020
Last Updated
August 29, 2023
Sponsor
Nova Scotia Health Authority
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1. Study Identification

Unique Protocol Identification Number
NCT04432311
Brief Title
Comparing a Group-based Guided Self-help Approach to Pure Self-help for the Treatment of BED
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
January 5, 2021 (Actual)
Primary Completion Date
June 28, 2022 (Actual)
Study Completion Date
July 20, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nova Scotia Health Authority

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Binge Eating Disorder
Keywords
Binge Eating Disorder, Binge Focused Therapy (BFT), Self-Help, Guided Self-Help

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
164 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Binge Focused Therapy (BFT)
Arm Type
Experimental
Arm Description
Guided self-help - Three online group sessions, homework, and self-guided check-ins to monitor continued progress and/or signs of relapse.
Arm Title
CBT Unguided Self Help (CBT USH)
Arm Type
Active Comparator
Arm Description
Pure self-help - The use of the book Overcoming Binge Eating and its associated homework.
Intervention Type
Behavioral
Intervention Name(s)
Binge Focused Therapy (BFT)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
CBT Unguided Self Help (CBT USH)
Intervention Description
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 Measure Information:
Title
Binge Eating Symptomology
Description
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.
Time Frame
Baseline to Post-Treatment (10 week)
Secondary Outcome Measure Information:
Title
Binge Eating Symptomology
Description
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.
Time Frame
6 week, 6-month follow-up, 12-month follow-up
Title
Binge Eating Frequency
Description
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.
Time Frame
Baseline, 6 week, 10 week, 6-month follow-up, 12-month follow-up
Title
Eating Disorder Symptomology (Eating Disorder Examination Questionnaire)
Description
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.
Time Frame
Baseline, 6 week, 10 week, 6-month follow-up, 12-month follow-up
Title
Clinical Impairment
Description
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.
Time Frame
Baseline, 6 week, 10 week, 6-month follow-up, 12-month follow-up
Title
Confidence to Change Binge Eating
Description
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.
Time Frame
Baseline, 6 week, 10 week, 6-month follow-up, 12-month follow-up
Title
Abstinence
Description
Abstinence is defined as a 100% reduction in binge episodes in the 28 days prior to collecting outcome measures.
Time Frame
Week 10, 6-month follow-up, 12-month follow-up
Title
Remission
Description
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).
Time Frame
Week 10, 6-month follow-up, 12-month follow-up
Title
Intervention Adherence
Description
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.
Time Frame
Week 6, Week 10
Title
Participant Expectations
Description
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.
Time Frame
Pre-Intervention, Week 1
Title
Satisfaction with Intervention
Description
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.
Time Frame
Week 10

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 informed 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) or any medication that could have an effect on appetite/binging (e.g., Saxenda) 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aaron Keshen, MD, FRCPC
Organizational Affiliation
Nova Scotia Health Authority
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nova Scotia Heath Authority
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2E2
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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

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