Cognitive-Behavioral and Physical Activity Interventions for Binge Eating and Overweight
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Yale University
- Enrollment
- 4
- Locations
- 1
- Primary Endpoint
- Binge-eating frequency
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •18 to 65 years old;
- •Meet DSM-5 criteria for BED or BED but without the size criterion (LOC eating);
- •BMI 25-45 kg/m2;
- •Sedentary activity pattern (< 90 mins/week of moderate-to-vigorous intensity recreational physical activity);
- •Available for the duration of the treatment and follow-up (7 months);
- •Read, comprehend, and write English at a sufficient level to complete study-related materials.
Exclusion Criteria
- •Co-existing psychiatric condition that requires hospitalization or more intensive treatment (e.g., bipolar mood disorders, psychotic illnesses, severe depression).
- •Reports active suicidal or homicidal ideation.
- •Current anorexia or bulimia nervosa.
- •Contraindications to physical activity.
- •Blood pressure >140 systolic or >90 diastolic.
- •Breast-feeding or pregnant, or planning to become pregnant during the study.
- •History of stroke or myocardial infarction.
- •Current or recent (within 12 months) drug or alcohol dependence
- •Currently receiving effective treatment for eating or weight loss.
- •Currently participating in another clinical study.
Arms & Interventions
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.
Intervention: Cognitive-Behavioral Therapy (Behavioral)
Outcomes
Primary Outcomes
Binge-eating frequency
Time Frame: 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
Time Frame: Post-treatment (4 months)
BMI is calculated using measured height and weight (e.g., percent loss)
Secondary Outcomes
No secondary outcomes reported