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

Not Applicable

Terminated

• Conditions: Binge Eating; Overweight and Obesity; Binge-Eating Disorder
• Interventions: Behavioral: Cognitive-Behavioral Therapy

• Registration Number: NCT03777189
• Lead Sponsor: Yale University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-12-05
• Study First Submitted: 2018-12-13
• Study First Submitted QC: 2018-12-13
• Study First Posted: 2018-12-17
• Primary Completion: 2019-06-03
• Study Completion: 2019-06-03
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-09
• Last Update Posted: 2019-10-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

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.

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cognitive-Behavioral Therapy	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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Yale School of Medicine; 🇺🇸 New Haven, Connecticut, United States