A Psychological and Behavioral Intervention for Post-Bariatric Patients

Not Applicable

Completed

• Conditions: Obesity

• Registration Number: NCT01453517
• Lead Sponsor: Mayo Clinic

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.

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.

Study Timeline

• Study Start: 2010-09
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Study First Submitted: 2011-09-27
• Status Verified: 2011-10
• Study First Submitted QC: 2011-10-13
• Last Update Submitted: 2011-10-13
• Study First Posted: 2011-10-18
• Last Update Posted: 2011-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
change in weight and BMI	weighed at baseline and six weeks [weighed weekly during 6 week intervention]

Secondary Outcome Measures

Name	Time	Method
distress tolerance	baseline, posttreatment (within 2 weeks of intervention completion) [measured over an average of 10-12 weeks]	emotion regulation and distress tolerance(Distress Tolerance Scale)
Mood	baseline, weekly during 6-week intervention, posttreatment (within 2 weeks of intervention completion)[measured over an average of 10-12 weeks]	Baseline and posttreatment measure: Structured Clinical Interview for DSM Disorders (SCID)-I Mood Module) Weekly during 6-week intervention: Beck Depression Inventory II
Maladaptive eating and purging	baseline, weekly during 6-week intervention, posttreatment (within 2 weeks of intervention completion)[measured over an average of 10-12 weeks]	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
Alcohol consumption	Baseline, weekly during 6-week intervention,posttreatment (within 2 weeks of intervention completion) [measured over an average of 10-12 weeks]	Baseline: SCID-I Substance Module Weekly during 6-week intervention: quantity, frequency, type of substance use

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States