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

Binge Eating Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04432311
• Other study ID #: BFT 2.0
• Status: Completed
• Phase: N/A
• Start date: January 5, 2021
• Est. completion date: July 20, 2023

Study information

• Verified date: August 2023
• Source: Nova Scotia Health Authority
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 Unpublished results of this uncontrolled study indicated that the sample experienced significant reductions in binge episodes per month, binge eating severity, general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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 164
• Est. completion date: July 20, 2023
• Est. primary completion date: June 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Binge Eating Disorder
• Binge-Eating Disorder
• Bulimia
• Feeding and Eating Disorders

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	Nova Scotia Heath Authority	Halifax	Nova Scotia

Sponsors (1)

Lead Sponsor	Collaborator
Nova Scotia Health Authority

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline to Post-Treatment (10 week)
Secondary	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.	6 week, 6-month follow-up, 12-month follow-up
Secondary	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.	Baseline, 6 week, 10 week, 6-month follow-up, 12-month follow-up
Secondary	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.	Baseline, 6 week, 10 week, 6-month follow-up, 12-month follow-up
Secondary	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.	Baseline, 6 week, 10 week, 6-month follow-up, 12-month follow-up
Secondary	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.	Baseline, 6 week, 10 week, 6-month follow-up, 12-month follow-up
Secondary	Abstinence	Abstinence is defined as a 100% reduction in binge episodes in the 28 days prior to collecting outcome measures.	Week 10, 6-month follow-up, 12-month follow-up
Secondary	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).	Week 10, 6-month follow-up, 12-month follow-up
Secondary	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.	Week 6, Week 10
Secondary	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.	Pre-Intervention, Week 1
Secondary	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.	Week 10