Back to resultsBinge Focused Therapy: A Guided, Self-help, Group-based Approach for Binge Eating Disorder
Primary Purpose
Binge-Eating Disorder, Eating Disorder
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Binge Focused Therapy (BFT) Intervention
Sponsored by
About this trial
This is an interventional treatment trial for Binge-Eating Disorder focused on measuring Guided self-help, Group-based intervention, Binge Focused Therapy, Brain Over Binge, Non-expert guided, Minimally intensive
Eligibility Criteria
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.
Sites / Locations
- Nova Scotia Health Authority
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental Group
Arm Description
Binge Focused Therapy (BFT) Intervention
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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 3 - 7 Adherence
Participants' adherence to tracking binge frequency and use of defusion skills (i.e., Homework) between Sessions 2 and 3.
Full Information
NCT ID
NCT03348475
First Posted
November 16, 2017
Last Updated
January 23, 2020
Sponsor
Nova Scotia Health Authority
1. Study Identification
Unique Protocol Identification Number
NCT03348475
Brief Title
Binge Focused Therapy: A Guided, Self-help, Group-based Approach for Binge Eating Disorder
Official Title
Binge Focused Therapy: Examining an Accessible, Cost-effective, Guided, Self-help, Group-based Approach for the Treatment of Binge Eating Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
October 3, 2019 (Actual)
Study Completion Date
October 3, 2019 (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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Binge-Eating Disorder, Eating Disorder
Keywords
Guided self-help, Group-based intervention, Binge Focused Therapy, Brain Over Binge, Non-expert guided, Minimally intensive
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
Binge Focused Therapy (BFT) Intervention
Intervention Type
Behavioral
Intervention Name(s)
Binge Focused Therapy (BFT) Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Binge Eating Frequency
Description
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.
Time Frame
Baseline, Week 8, 1-year follow-up
Secondary Outcome Measure Information:
Title
Change in Binge Eating Severity
Description
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.
Time Frame
Baseline, Week 2, Week 8, 1-year follow-up
Title
Remission Rate
Description
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.
Time Frame
Week 8, 1-year follow up
Title
Response Rate
Description
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.
Time Frame
Week 8, 1-year follow up
Title
Change in General Eating Disorder Symptomatology
Description
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.
Time Frame
Baseline, Week 8, 1-year follow-up
Title
Change in Locus of Control of Behaviour
Description
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.
Time Frame
Baseline, Week 2, Week 8, 1-year follow-up
Title
Change in Coping Self-Efficacy
Description
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.
Time Frame
Baseline, Week 2, Week 8, 1-year follow-up
Title
Motivation/Confidence/Readiness for Behaviour Change
Description
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.
Time Frame
Baseline and Week 2
Title
Depression, Anxiety and Tension/Stress
Description
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.
Time Frame
Baseline
Title
Participant Satisfaction with Intervention
Description
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.
Time Frame
Week 8
Title
Week 3 - 7 Adherence
Description
Participants' adherence to tracking binge frequency and use of defusion skills (i.e., Homework) between Sessions 2 and 3.
Time Frame
Week 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Nova Scotia Health Authority
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H2E2
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Binge Focused Therapy: A Guided, Self-help, Group-based Approach for Binge Eating Disorder
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