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

NCT04432311 | Completed

• 1 other identifier: BFT 2.0
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

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 Unpublished results of this uncontrolled study indicated that the sample experienced significant reductions in binge episodes per month, binge eating severity, general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

Conditions

Binge Eating Disorder

Keywords

Binge Eating Disorder; Binge Focused Therapy (BFT); Self-Help; Guided Self-Help

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Binge Eating Symptomology

  6 week, 6-month follow-up, 12-month follow-up

• Binge Eating Frequency

  Baseline, 6 week, 10 week, 6-month follow-up, 12-month follow-up

• Eating Disorder Symptomology (Eating Disorder Examination Questionnaire)

  Baseline, 6 week, 10 week, 6-month follow-up, 12-month follow-up

• Clinical Impairment

  Baseline, 6 week, 10 week, 6-month follow-up, 12-month follow-up

• Confidence to Change Binge Eating

  Baseline, 6 week, 10 week, 6-month follow-up, 12-month follow-up

Study Arms (2)

Binge Focused Therapy (BFT)

EXPERIMENTAL

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)

CBT Unguided Self Help (CBT USH)

ACTIVE COMPARATOR

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

Behavioral: CBT Unguided Self Help (CBT USH)

Interventions

Binge Focused Therapy (BFT) BEHAVIORAL

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.

Binge Focused Therapy (BFT)

CBT Unguided Self Help (CBT USH) BEHAVIORAL

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.

CBT Unguided Self Help (CBT USH)

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• Currently receiving psychotherapy/treatment for BED (as determined by PI)
• Self-reported Body Mass Index on pre-screening questionnaire \< 20 kg/m2
• 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)

Sponsors & Collaborators

• Nova Scotia Health Authority: lead

Study Sites (1)

Nova Scotia Heath Authority

Halifax, Nova Scotia, B3H 2E2, Canada

Location

MeSH Terms

Conditions

Binge-Eating Disorder

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Study Officials

• Aaron Keshen, MD, FRCPC

  Nova Scotia Health Authority

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Psychiatrist, Principal Investigator

Study Record Dates

• First Submitted: June 11, 2020
• First Posted: June 16, 2020
• Study Start: January 5, 2021
• Primary Completion: June 28, 2022
• Study Completion: July 20, 2023
• Last Updated: August 30, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)