NCT03348475

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 16, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 21, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 3, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 3, 2019

Completed
Last Updated

January 27, 2020

Status Verified

January 1, 2020

Enrollment Period

1.7 years

First QC Date

November 16, 2017

Last Update Submit

January 23, 2020

Conditions

Binge-Eating DisorderEating Disorder

Keywords

Guided self-helpGroup-based interventionBinge Focused TherapyBrain Over BingeNon-expert guidedMinimally intensive

Outcome Measures

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.

    Baseline, Week 8, 1-year follow-up

Secondary Outcomes (10)

  • Change in Binge Eating Severity

    Baseline, Week 2, Week 8, 1-year follow-up

  • Remission Rate

    Week 8, 1-year follow up

  • Response Rate

    Week 8, 1-year follow up

  • Change in General Eating Disorder Symptomatology

    Baseline, Week 8, 1-year follow-up

  • Change in Locus of Control of Behaviour

    Baseline, Week 2, Week 8, 1-year follow-up

  • +5 more secondary outcomes

Study Arms (1)

Experimental Group

EXPERIMENTAL

Binge Focused Therapy (BFT) Intervention

Behavioral: Binge Focused Therapy (BFT) Intervention

Interventions

Binge Focused Therapy (BFT) InterventionBEHAVIORAL

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.

Experimental Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nova Scotia Health Authority

Halifax, Nova Scotia, B3H2E2, Canada

Location

MeSH Terms

Conditions

Binge-Eating DisorderFeeding and Eating Disorders

Interventions

Methods

Condition Hierarchy (Ancestors)

Mental DisordersSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Psychiatrist

Study Record Dates

First Submitted

November 16, 2017

First Posted

November 21, 2017

Study Start

February 1, 2018

Primary Completion

October 3, 2019

Study Completion

October 3, 2019

Last Updated

January 27, 2020

Record last verified: 2020-01

Locations

CA(1)