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Clinical Trials/NCT03777189
NCT03777189
Terminated
N/A

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

Yale University1 site in 1 country4 target enrollmentDecember 5, 2018

Overview

Phase
N/A
Intervention
Not specified
Conditions
Binge-Eating Disorder
Sponsor
Yale University
Enrollment
4
Locations
1
Primary Endpoint
Binge-eating frequency
Status
Terminated
Last Updated
6 years ago

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.

Registry
clinicaltrials.gov
Start Date
December 5, 2018
End Date
June 3, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Exclusion Criteria

  • Not provided

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)

Study Sites (1)

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