Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
140 participants
INTERVENTIONAL
2014-09-30
2018-07-31
Brief Summary
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1. Behavioral Weight Loss Treatment
2. Cognitive Behavioral Therapy
These treatments will be compared to Standard-of-Care.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Standard-of-Care
Standard-of-care is the continuation of any treatment or recommendations participants receive from his/her bariatric surgeon/team.
Standard-of-Care
Standard-of-Care with bariatric team. Participants will be encouraged to continue their care with their bariatric team.
Behavioral Weight Loss Treatment
Guided self-help Behavioral Weight Loss Treatment
Behavioral Weight Loss Treatment
Biweekly individual guided self-help sessions for 3 months
Cognitive Behavioral Therapy
Guided self-help Cognitive Behavioral Therapy
Cognitive Behavioral Therapy
Biweekly individual guided self-help sessions for 3 months
Interventions
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Cognitive Behavioral Therapy
Biweekly individual guided self-help sessions for 3 months
Standard-of-Care
Standard-of-Care with bariatric team. Participants will be encouraged to continue their care with their bariatric team.
Behavioral Weight Loss Treatment
Biweekly individual guided self-help sessions for 3 months
Eligibility Criteria
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Inclusion Criteria
* 5-8 months post-bariatric surgery
* Regular loss of control eating (once weekly during past month)
* Read English proficiently enough to read patient self-care materials and study assessments
* Available for duration of treatment plus follow-up period
* Agree to study procedures
Exclusion Criteria
* Medical status judged by the surgeon as contraindication (rare instances of need for additional surgery or medical instability)
* Unable to ambulate
* Current medications that influence eating/weight
* Current substance dependence or other severe psychiatric disturbance (e.g., suicidality) that requires immediate treatment
18 Years
65 Years
ALL
No
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Yale University
OTHER
Responsible Party
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Principal Investigators
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Carlos M Grilo, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Yale University School of Medicine, Department of Psychiatry
Locations
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Yale Department of Psychiatry
New Haven, Connecticut, United States
Countries
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References
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Lawson JL, Wiedemann AA, Carr MM, Ivezaj V, Duffy AJ, Grilo CM. Examining Sleep Quality Following Sleeve Gastrectomy Among Patients with Loss-of-Control Eating. Obes Surg. 2019 Oct;29(10):3264-3270. doi: 10.1007/s11695-019-03981-7.
Other Identifiers
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1205010224
Identifier Type: -
Identifier Source: org_study_id
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