A Psychological and Behavioral Intervention for Post-Bariatric Patients
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| First Received Date ICMJE | September 27, 2011 | ||||||||
| Last Updated Date | October 13, 2011 | ||||||||
| Start Date ICMJE | September 2010 | ||||||||
| Primary Completion Date | August 2011 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
change in weight and BMI [ Time Frame: weighed at baseline and six weeks [weighed weekly during 6 week intervention] ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01453517 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | A Psychological and Behavioral Intervention for Post-Bariatric Patients | ||||||||
| Official Title ICMJE | Dialectical Behavior Therapy (DBT) for Post-Bariatric Patients Experiencing Weight Regain | ||||||||
| Brief Summary | The study is designed to test a pilot intervention for bariatric patients who are starting to regain weight after the 1st year post-surgery. Dialectical Behavior Therapy (DBT), an empirically supported therapy for Borderline Personality Disorder, has also successfully been applied to patients with substance use and binge eating problems. The purpose of this study is to develop and test a group intervention based on DBT and cognitive behavioral therapy (CBT) techniques for patients engaging in these maladaptive behaviors after surgery with co-occuring weight gain. |
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| Detailed Description | Weight regain post bariatric surgery may be due to anatomical, physiological, or psychological and behavioral factors. One potential psychological and behavioral contributor to poor weight loss outcome following bariatric surgery may be low distress tolerance, characterized by emotional reactivity to stressors and lack of appropriate emotional regulation, and using eating, drinking, or other substances to improve mood. Recent research indicates that a subset of patients post-surgery experience challenges with subjective bulimic episodes, graze eating, and alcohol misuse; evidence for poorer excess weight loss (EWL) outcomes is associated with graze eating and uncontrolled eating behavior. This submission is for a pilot project designed to examine the impact of participation in a dialectical behavior therapy (DBT) plus cognitive behavioral therapy intervention delivered post-surgery on weight, psychological, and behavioral outcomes after Roux-en-Y gastric bypass surgery (RYGB) for patients experiencing weight regain relapse with co-occuring disordered eating or substance misuse behaviors. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
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| Condition ICMJE | Obesity | ||||||||
| Intervention ICMJE | Behavioral: Behavioral intervention for regain after bariatric surgery
6 week intervention targeting dietary behavioral adherence, stress management, and distress tolerance skills to prevent weight regain
Other Name: CBT-DBT intervention |
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| Study Arm (s) | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 26 | ||||||||
| Completion Date | August 2011 | ||||||||
| Primary Completion Date | August 2011 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion criteria
Exclusion criteria
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| Gender | Both | ||||||||
| Ages | 18 Years to 75 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01453517 | ||||||||
| Other Study ID Numbers ICMJE | 10-004976 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Karen Grothe, Mayo Clinic | ||||||||
| Study Sponsor ICMJE | Mayo Clinic | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Mayo Clinic | ||||||||
| Verification Date | October 2011 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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