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

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ClinicalTrials.gov Identifier: NCT03348475
Recruitment Status : Not yet recruiting
First Posted : November 21, 2017
Last Update Posted : November 22, 2017
Sponsor:
Information provided by (Responsible Party):
Aaron Keshen, Nova Scotia Health Authority

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.

Condition or disease Intervention/treatment Phase
Binge-Eating Disorder Eating Disorder Behavioral: Binge Focused Therapy (BFT) Intervention Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Binge Focused Therapy: Examining an Accessible, Cost-effective, Guided, Self-help, Group-based Approach for the Treatment of Binge Eating Disorder
Estimated Study Start Date : January 2019
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eating Disorders

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.




Primary Outcome Measures :
  1. Change in Binge Eating Frequency [ Time Frame: Baseline, Week 8, 1-year follow-up ]
    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 :
  1. Change in Binge Eating Severity [ Time Frame: Baseline, Week 2, Week 8, 1-year follow-up ]
    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.

  2. Remission Rate [ Time Frame: Week 8, 1-year follow up ]
    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.

  3. Response Rate [ Time Frame: Week 8, 1-year follow up ]
    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.

  4. Change in General Eating Disorder Symptomatology [ Time Frame: Baseline, Week 8, 1-year follow-up ]
    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.

  5. Change in Locus of Control of Behaviour [ Time Frame: Baseline, Week 2, Week 8, 1-year follow-up ]
    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.

  6. Change in Coping Self-Efficacy [ Time Frame: Baseline, Week 2, Week 8, 1-year follow-up ]
    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.

  7. Motivation/Confidence/Readiness for Behaviour Change [ Time Frame: Baseline and Week 2 ]
    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.

  8. Depression, Anxiety and Tension/Stress [ Time Frame: Baseline ]
    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.

  9. Participant Satisfaction with Intervention [ Time Frame: Week 8 ]
    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.

  10. Week 3 - 7 Adherence [ Time Frame: Week 8 ]
    Participants' adherence to tracking binge frequency and use of defusion skills (i.e., Homework) between Sessions 2 and 3.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03348475


Contacts
Contact: Aaron Keshen, MD, FRCPC 9024498228 Aaron.Keshen@nshealth.ca

Sponsors and Collaborators
Nova Scotia Health Authority

Responsible Party: Aaron Keshen, Psychiatrist, Nova Scotia Health Authority
ClinicalTrials.gov Identifier: NCT03348475     History of Changes
Other Study ID Numbers: BFT
First Posted: November 21, 2017    Key Record Dates
Last Update Posted: November 22, 2017
Last Verified: November 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Aaron Keshen, Nova Scotia Health Authority:
Guided self-help
Group-based intervention
Binge Focused Therapy
Brain Over Binge
Non-expert guided
Minimally intensive

Additional relevant MeSH terms:
Disease
Feeding and Eating Disorders
Binge-Eating Disorder
Bulimia
Pathologic Processes
Mental Disorders
Hyperphagia
Signs and Symptoms, Digestive
Signs and Symptoms