Binge Focused Therapy: A Guided, Self-help, Group-based Approach for Binge Eating Disorder

Binge Focused Therapy: Examining an Accessible, Cost-effective, Guided, Self-help, Group-based Approach for the Treatment of Binge Eating Disorder

The "Brain Over Binge Recovery Guide" (Hansen, 2016), is a self-help approach that incorporates fundamental aspects of Acceptance and Commitment Therapy, Dialectical Behavioural Therapy, Motivational Enhancement Therapy and addictions treatment. This approach has been streamlined into a guided self-help protocol (Binge Focused Therapy, or BFT) that can be delivered by undergraduate students with minimal mental health experience in 3 group sessions spread over 8 weeks (i.e., Week 1, Week 2, Week 8). The aim of this proof-of-concept study is to provide preliminary data to examine whether this approach is feasible and has clinical potential for patients with binge eating disorder.

Study Overview

• Status: Completed
• Conditions: Binge-Eating Disorder; Eating Disorder
• Intervention / Treatment: Behavioral: Binge Focused Therapy (BFT) Intervention

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H2E2
      • Nova Scotia Health Authority

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age 18 years or older;
• Meets DSM-5 criteria for moderate to severe Binge Eating Disorder (BED) as determined through screening interview by an eating disorder psychiatrist and validated with the Eating Disorder Diagnostic Scale (a self-report screening tool);
• Provides written informed consent.

Exclusion Criteria:

• Currently receiving treatment for BED;
• Is taking a psychotropic medication (e.g., antidepressant, stimulant, etc.) AND the dose has been changed 2 weeks prior to baseline;
• Insufficient knowledge of English.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group; Binge Focused Therapy (BFT) Intervention	Behavioral: Binge Focused Therapy (BFT) Intervention; The intervention, Binge Focused Therapy, is a 3-session, 8-week, non-expert guided self-help program. Participants will attend sessions at Week 1, Week 2, and Week 8 at the Nova Scotia Health Authority Eating Disorder Clinic. Each session will be approximately 2 hours in length.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Binge Eating Frequency	Self-reported binge eating frequency will be assessed with the Eating Disorder Examination Questionnaire 6.0 (EDE-Q). Binge eating frequency is measured on item 15 of the EDE-Q.	Baseline, Week 8, 1-year follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Binge Eating Severity	Self-reported binge eating severity will be assessed with 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, Week 2, Week 8, 1-year follow-up
Remission Rate	Remission defined as 100% reduction in binge episodes in the last 28 days of treatment phase preceding week 8, or in the last 28-days of follow-up phase.	Week 8, 1-year follow up
Response Rate	Responders defined as ≥ 50% reduction in the number of binge episodes from baseline to either of the last two preceding weeks of treatment or follow-up.	Week 8, 1-year follow up
Change in General Eating Disorder Symptomatology	Self-reported general eating disorder symptomatology will be assessed using the global score generated from the EDE-Q. 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, Week 8, 1-year follow-up
Change in Locus of Control of Behaviour	Self-reported locus of control of behaviour will be assessed using the Locus of Control of Behaviour scale (LCB). The LCB scale is a 17-item measure. Participants respond to each item using a Likert scale ranging from 0 (strongly disagree) to 5 (strongly agree). Total scores range from 0-85, with higher scores indicating a greater degree of externality.	Baseline, Week 2, Week 8, 1-year follow-up
Change in Coping Self-Efficacy	Self-reported coping self-efficacy will be assessed using the Coping Self-Efficacy Scale (CSES). The CSES is a 26-item measure. Each item with be rated using a Likert scale from 1 (cannot do at all) to 10 (certain can do). An average score will be obtained. Higher scores indicate greater coping self-efficacy.	Baseline, Week 2, Week 8, 1-year follow-up
Motivation/Confidence/Readiness for Behaviour Change	This will be measured using responses to three Likert-style questions that assess the perceived value of changing binge eating, confidence in ability to change binge eating, and readiness to change binge eating. Each item will be scored on a scale of 1 (not at all important/confident/ready) to 10 (extremely important/confident/ready). Each item will be assessed independently. Higher scores indicate greater motivation, confidence, and readiness.	Baseline and Week 2
Depression, Anxiety and Tension/Stress	Self-reported depression, anxiety, and tension/stress will be assessed using the Depression Anxiety Stress Scale (DASS). Participants will respond to 21-items each scored on a Likert scale from 0 (did not apply) to 3 (applied very much or most of the time). A total score ranges from 0-126 with a higher score indicating greater impairment.	Baseline
Participant Satisfaction with Intervention	Participants will respond to 3 Likert-style questions on a scale of 1 (very poor) to 6 (excellent) and several open-ended questions asking about their perceptions of the program. Higher scores indicate greater satisfaction.	Week 8
Week 3 - 7 Adherence	Participants' adherence to tracking binge frequency and use of defusion skills (i.e., Homework) between Sessions 2 and 3.	Week 8

Collaborators and Investigators

• Sponsor: Nova Scotia Health Authority

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2018
• Primary Completion (Actual): October 3, 2019
• Study Completion (Actual): October 3, 2019

Study Registration Dates

• First Submitted: November 16, 2017
• First Submitted That Met QC Criteria: November 17, 2017
• First Posted (Actual): November 21, 2017

Study Record Updates

• Last Update Posted (Actual): January 27, 2020
• Last Update Submitted That Met QC Criteria: January 23, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Guided self-help; Group-based intervention; Binge Focused Therapy; Brain Over Binge; Non-expert guided; Minimally intensive
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Signs and Symptoms, Digestive; Hyperphagia; Disease; Bulimia; Feeding and Eating Disorders; Binge-Eating Disorder
• Other Study ID Numbers: BFT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No