A Psychological and Behavioral Intervention for Post-Bariatric Patients

October 13, 2011 updated by: Karen Grothe, Mayo Clinic

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
distress tolerance
Time Frame: baseline, posttreatment (within 2 weeks of intervention completion) [measured over an average of 10-12 weeks]
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
Time Frame: 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
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
Time Frame: 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
baseline, weekly during 6-week intervention, posttreatment (within 2 weeks of intervention completion)[measured over an average of 10-12 weeks]
Alcohol consumption
Time Frame: 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
Baseline, weekly during 6-week intervention,posttreatment (within 2 weeks of intervention completion) [measured over an average of 10-12 weeks]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Karen Grothe, PhD, LP, Mayo Clinic
  • Principal Investigator: Susan Himes, PhD, Lifespan/Brown Medical School

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

September 27, 2011

First Submitted That Met QC Criteria

October 13, 2011

First Posted (Estimate)

October 18, 2011

Study Record Updates

Last Update Posted (Estimate)

October 18, 2011

Last Update Submitted That Met QC Criteria

October 13, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10-004976

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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