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

Study Overview
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Brief Summary
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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.

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

Conditions
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Binge-Eating Disorder, Binge Eating, Overweight and Obesity

Intervention / Treatment
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* Behavioral: Cognitive-Behavioral Therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive-Behavioral Therapy<br>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<br>* 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.<br>|

What is the study measuring?
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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) |