Cognitive-Behavioral and Physical Activity Interventions for Binge Eating and Overweight

This study aims to perform an open-series pilot trial to examine the efficacy of cognitive-behavioral therapy delivered in a guided self-help format (CBTgsh) with added content related to physical activity (PA), for the treatment of binge-eating disorder (BED), operationalized as BED full diagnostic criteria or BED with the full criteria except for the binge episode size criterion.

Study Overview

• Status: Terminated
• Conditions: Binge-Eating Disorder; Overweight and Obesity; Binge Eating
• Intervention / Treatment: Behavioral: Cognitive-Behavioral Therapy

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06519
      • Yale School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 18 to 65 years old;
2. Meet DSM-5 criteria for BED or BED but without the size criterion (LOC eating);
3. BMI 25-45 kg/m2;
4. Sedentary activity pattern (< 90 mins/week of moderate-to-vigorous intensity recreational physical activity);
5. Available for the duration of the treatment and follow-up (7 months);
6. Read, comprehend, and write English at a sufficient level to complete study-related materials.

Exclusion criteria:

1. Co-existing psychiatric condition that requires hospitalization or more intensive treatment (e.g., bipolar mood disorders, psychotic illnesses, severe depression).
2. Reports active suicidal or homicidal ideation.
3. Current anorexia or bulimia nervosa.
4. Contraindications to physical activity.
5. Blood pressure >140 systolic or >90 diastolic.
6. Breast-feeding or pregnant, or planning to become pregnant during the study.
7. History of stroke or myocardial infarction.
8. Current or recent (within 12 months) drug or alcohol dependence
9. Currently receiving effective treatment for eating or weight loss.
10. Currently participating in another clinical study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cognitive-Behavioral Therapy; Cognitive-behavioral therapy will be delivered in line with recommendations (e.g., NICE 2017). Format will be guided self help with added content related to physical activity.	Behavioral: Cognitive-Behavioral Therapy; Cognitive-behavioral therapy will be delivered in line with recommendations (e.g., NICE 2017). Format will be guided self help with added content related to physical activity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Binge-eating frequency	Binge eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency will be defined continuously (analyzed dimensionally).	Post-treatment (4 months)
Body mass index	BMI is calculated using measured height and weight (e.g., percent loss)	Post-treatment (4 months)

Collaborators and Investigators

• Sponsor: Yale University
• Investigators: Principal Investigator: Carlos Grilo, Yale University

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2018
• Primary Completion (Actual): June 3, 2019
• Study Completion (Actual): June 3, 2019

Study Registration Dates

• First Submitted: December 13, 2018
• First Submitted That Met QC Criteria: December 13, 2018
• First Posted (Actual): December 17, 2018

Study Record Updates

• Last Update Posted (Actual): October 10, 2019
• Last Update Submitted That Met QC Criteria: October 9, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Signs and Symptoms, Digestive; Body Weight; Hyperphagia; Bulimia; Feeding and Eating Disorders; Binge-Eating Disorder; Overweight
• Other Study ID Numbers: 2000023412

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No