CClinicalTrials.gg
CompletedNCT03348475Updated Jan 27, 2020

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

An interventional study of Binge Focused Therapy (BFT) Intervention in Binge-Eating Disorder and Eating Disorder, sponsored by Nova Scotia Health Authority. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-01-27.

Sponsored by Nova Scotia Health Authority · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
38
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Binge-Eating Disorder
  • Eating Disorder

Keywords

  • Guided self-help
  • Group-based intervention
  • Binge Focused Therapy
  • Brain Over Binge
  • Non-expert guided
  • Minimally intensive
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
38 participants (actual)

Study arms

  • Experimental
    Experimental Group

    Binge Focused Therapy (BFT) Intervention

    Behavioral: Binge Focused Therapy (BFT) Intervention

Interventions

  • BehavioralBinge 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.

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline, Week 8, 1-year follow-up

Secondary outcomes

  1. 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.

    Time frame: Baseline, Week 2, Week 8, 1-year follow-up

  2. 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.

    Time frame: Week 8, 1-year follow up

  3. 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.

    Time frame: Week 8, 1-year follow up

  4. 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.

    Time frame: Baseline, Week 8, 1-year follow-up

  5. 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.

    Time frame: Baseline, Week 2, Week 8, 1-year follow-up

  6. 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.

    Time frame: Baseline, Week 2, Week 8, 1-year follow-up

  7. 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.

    Time frame: Baseline and Week 2

  8. 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.

    Time frame: Baseline

  9. 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.

    Time frame: Week 8

  10. Week 3 - 7 Adherence

    Participants' adherence to tracking binge frequency and use of defusion skills (i.e., Homework) between Sessions 2 and 3.

    Time frame: Week 8

06

Study locations

1 site
  • Nova Scotia Health Authority
    Halifax, Nova Scotia B3H2E2, Canada
07

Registry details

Key details

Study ID
NCT03348475
Lead sponsor
Nova Scotia Health Authority
Responsible party
Aaron Keshen (Psychiatrist, Nova Scotia Health Authority) — Principal investigator
First posted
Nov 21, 2017
Start date
Feb 1, 2018
Primary completion
Oct 3, 2019
Completion
Oct 3, 2019
Last update
Jan 27, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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