A Psychological and Behavioral Intervention for Post-Bariatric Patients

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2011-08-31

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.

Conditions

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Obesity

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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Behavioral intervention for regain after bariatric surgery

6 week intervention targeting dietary behavioral adherence, stress management, and distress tolerance skills to prevent weight regain

Intervention Type BEHAVIORAL

Other Intervention Names

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CBT-DBT intervention

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Karen Grothe

Principal Investigator, Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Karen Grothe, PhD, LP

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Susan Himes, PhD

Role: PRINCIPAL_INVESTIGATOR

Lifespan/Brown Medical School

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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10-004976

Identifier Type: -

Identifier Source: org_study_id