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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 : Active, not recruiting
First Posted : November 21, 2017
Last Update Posted : January 31, 2019
Sponsor:
Information provided by (Responsible Party):
Aaron Keshen, Nova Scotia Health Authority

Tracking Information
First Submitted Date  ICMJE November 16, 2017
First Posted Date  ICMJE November 21, 2017
Last Update Posted Date January 31, 2019
Actual Study Start Date  ICMJE February 1, 2018
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 20, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 17, 2017)
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).
Change History Complete list of historical versions of study NCT03348475 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 20, 2017)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 17, 2017)
  • 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.
  • Remission [ 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.
  • Response [ 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.
  • 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.
  • 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).
  • 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).
  • Motivation/Confidence/Readiness for Behaviour Change [ Time Frame: Baseline and Week 2 ]
    This will be measured using responses to three questions that assess the perceived value of changing binge eating, confidence in ability to change binge eating and readiness to change binge eating.
  • 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).
  • Participant Satisfaction with Intervention [ Time Frame: Week 8 ]
    Participants will respond to developed Likert style and open-ended questions asking about their perceptions of the program
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Binge Focused Therapy: A Guided, Self-help, Group-based Approach for Binge Eating Disorder
Official Title  ICMJE Binge Focused Therapy: Examining an Accessible, Cost-effective, Guided, Self-help, Group-based Approach for the Treatment of Binge Eating Disorder
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Binge-Eating Disorder
  • Eating Disorder
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: Experimental Group
Binge Focused Therapy (BFT) Intervention
Intervention: Behavioral: Binge Focused Therapy (BFT) Intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: January 29, 2019)
38
Original Estimated Enrollment  ICMJE
 (submitted: November 17, 2017)
40
Estimated Study Completion Date  ICMJE September 2019
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03348475
Other Study ID Numbers  ICMJE BFT
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Aaron Keshen, Nova Scotia Health Authority
Study Sponsor  ICMJE Nova Scotia Health Authority
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Nova Scotia Health Authority
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP