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

NCT ID: NCT04432311

Last Updated: 2023-08-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 164 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-05
• Study Completion Date: 2023-07-20

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 Unpublished results of this uncontrolled study indicated that the sample experienced significant reductions in binge episodes per month, binge eating severity, general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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Binge Focused Therapy (BFT)

Intervention Type: 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.

CBT Unguided Self Help (CBT USH)

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

Group Type: ACTIVE_COMPARATOR

CBT Unguided Self Help (CBT USH)

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nova Scotia Health Authority

OTHER

Sponsor Role: lead

Responsible Party

Aaron Keshen

Psychiatrist, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Aaron Keshen, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

Nova Scotia Health Authority

Locations

Nova Scotia Heath Authority

Halifax, Nova Scotia, Canada

Countries

Canada

Other Identifiers

BFT 2.0

Identifier Type: -

Identifier Source: org_study_id