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

NCT ID: NCT03777189

Last Updated: 2019-10-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-05
• Study Completion Date: 2019-06-03

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.

Conditions

Binge-Eating Disorder; Binge Eating; Overweight and Obesity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Cognitive-Behavioral Therapy

Intervention Type: BEHAVIORAL

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.

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 Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carlos Grilo

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Yale School of Medicine

New Haven, Connecticut, United States

Countries

United States

Other Identifiers

2000023412

Identifier Type: -

Identifier Source: org_study_id