A Psychological and Behavioral Intervention for Post-Bariatric Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Dialectical Behavior Therapy (DBT) for Post-Bariatric Patients Experiencing Weight Regain

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: Behavioral intervention for regain after bariatric surgery


Participation Criteria
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Eligibility Criteria
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Inclusion criteria regained ≥ 15% of total post-surgical weight lost has either disregulated eating, drinking, or misuse of chemical substance age 18-75 ability to participate in group completed first Roux-en-Y gastric bypass procedure at Mayo Clinic Exclusion criteria patients with an uncontrolled psychiatric diagnosis patients severely impaired by drug or alcohol use completed surgical intervention at location other than Mayo Clinic more than one bariatric procedure

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|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|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in weight and BMI |  | weighed at baseline and six weeks [weighed weekly during 6 week intervention] | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| distress tolerance | emotion regulation and distress tolerance(Distress Tolerance Scale) | baseline, posttreatment (within 2 weeks of intervention completion) [measured over an average of 10-12 weeks] | 
| Mood | Baseline and posttreatment measure: Structured Clinical Interview for DSM Disorders (SCID)-I Mood Module) Weekly during 6-week intervention: Beck Depression Inventory II | baseline, weekly during 6-week intervention, posttreatment (within 2 weeks of intervention completion)[measured over an average of 10-12 weeks] | 
| Maladaptive eating and purging | Baseline and posttreatment measures: Eating Disorder Diagnostic Scale, modified Eating Disorder Examination-Q Weekly during 6-week intervention: modified Eating Disorder Examination-Q, food diary, number of eating episodes and number of snacks to quantify graze eating | baseline, weekly during 6-week intervention, posttreatment (within 2 weeks of intervention completion)[measured over an average of 10-12 weeks] | 
| Alcohol consumption | Baseline: SCID-I Substance Module Weekly during 6-week intervention: quantity, frequency, type of substance use | Baseline, weekly during 6-week intervention,posttreatment (within 2 weeks of intervention completion) [measured over an average of 10-12 weeks] | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bariatric, obesity, post-surgery, intervention