Clinical trial NCT04432311: Comparing a Group-based Guided Self-help Approach to Pure Self-help for the Treatment of BED
Official title: A Randomized Controlled Trial Comparing a Group-based Guided Self-help Approach to Pure Self-help for the Treatment of Binge Eating Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Binge Eating Disorder
Keywords: Binge Eating Disorder
Binge Focused Therapy (BFT)
Self-Help
Guided Self-Help
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
First posted: 2020-06-16
Enrollment: 164
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Binge eating disorder (BED) is the most common eating disorder in adults, affecting 2.8% of the population. The disorder is characterized by recurrent episodes of binge eating which are not followed by inappropriate compensatory behaviours such as self-induced vomiting. BED is associated with an increased risk of health complications, significant impairment to social and occupational functioning, and reduced quality of life. Despite the negative consequences associated with this disorder, standard therapy for BED is often inaccessible and costly.

To address the limitations of standard therapy for BED our research team has developed Binge Focused Therapy (BFT) as an innovative, guided self-help approach to BED treatment. BFT was derived from elements of "The Brain Over Binge Recovery Guide" by Kathryn Hansen, which incorporates fundamental aspects of Acceptance and Commitment Therapy, Dialectical Behaviour Therapy, Motivational Enhancement Therapy, and addictions treatment. We further streamlined this approach into a protocol that can be delivered by non eating disorder specialists (e.g., honours psychology students, nurses, occupational therapists).

In 2018, our research team conducted a proof-of-concept pilot study with a sample of 40 individuals with BED. Unpublished results of this uncontrolled study indicated that the sample experienced significant reductions in binge episodes per month, binge eating severity, general eating disorder symptomology, and improved confidence in changing binge eating behaviours.

Although the results from this small, uncontrolled, proof-of-concept study are encouraging, qualitative and quantitative data highlighted several aspects of the BFT intervention that could be altered and tested in a randomized controlled trial that compares BFT to an active comparator.


Eligibility criteria: Inclusion Criteria:

* Meets criteria for Diagnostic and Statistical Manual of Mental Disorders (5th Edition) diagnosis of BED (mild-extreme) as per Eating Disorder Examination - Mild severity will be modified from a minimum of 1 objective binge episode/week to 2 objective binge episodes per week
* Age 18 or older
* Access to computer with internet connection and webcam that can be used in a private area
* Virtually signed informed consent form

Exclusion Criteria:

* Currently receiving psychotherapy/treatment for BED (as determined by PI)
* Self-reported Body Mass Index on pre-screening questionnaire \< 20 kg/m2
* Dose change of a psychotropic medication used for the treatment of BED (e.g., Vyvanse, topiramate, antidepressants) or any medication that could have an effect on appetite/binging (e.g., Saxenda) within 4 weeks of study inclusion (as determined by PI)
* Insufficient knowledge of English
* Previously participated in proof-of-concept BFT study
* Previously read Overcoming Binge Eating by C. Fairburn and implemented strategies presented in the book (as determined by PI)
* Serious physical illness (e.g., severe uncontrolled insulin dependent diabetes) (as determined by PI)
* Currently pregnant
* Scores greater than 20 on the Quick Inventory of Depressive Symptomatology Self-Report and PI determines participant is significantly depressed (as determined by PI)
* Currently experiencing serious issues with alcohol or drugs (as determined by PI)
* Currently engaging in self-harm behaviours (as determined by PI)

Primary outcomes:
measure: Binge Eating Symptomology
timeFrame: Baseline to Post-Treatment (10 week)
Secondary outcomes:
measure: Binge Eating Symptomology
timeFrame: 6 week, 6-month follow-up, 12-month follow-up
measure: Binge Eating Frequency
timeFrame: Baseline, 6 week, 10 week, 6-month follow-up, 12-month follow-up
measure: Eating Disorder Symptomology (Eating Disorder Examination Questionnaire)
timeFrame: Baseline, 6 week, 10 week, 6-month follow-up, 12-month follow-up
measure: Clinical Impairment
timeFrame: Baseline, 6 week, 10 week, 6-month follow-up, 12-month follow-up
measure: Confidence to Change Binge Eating
timeFrame: Baseline, 6 week, 10 week, 6-month follow-up, 12-month follow-up
measure: Abstinence
timeFrame: Week 10, 6-month follow-up, 12-month follow-up
measure: Remission
timeFrame: Week 10, 6-month follow-up, 12-month follow-up
measure: Intervention Adherence
timeFrame: Week 6, Week 10
measure: Participant Expectations
timeFrame: Pre-Intervention, Week 1
measure: Satisfaction with Intervention
timeFrame: Week 10
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Nova Scotia Heath Authority
state: Nova Scotia
Study officials:
affiliation: Nova Scotia Health Authority
name: Aaron Keshen, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References: