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Completed

NCT Number: NCT03348475

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

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Key information

Conditions

Binge-Eating Disorder Eating Disorder Feeding and Eating Disorders Mental Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nova Scotia Health Authority

Halifax, Nova Scotia, B3H2E2, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Binge Focused Therapy (BFT) Intervention

Behavioral

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Nova Scotia Health Authority

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 21, 2017
Registry last updated
Jan 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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