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A Psychological and Behavioral Intervention for Post-Bariatric Patients

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Behavioral intervention for regain after bariatric surgery
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity focused on measuring bariatric, obesity, post-surgery, intervention

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mayo Clinic in Rochester

Outcomes

Primary Outcome Measures

change in weight and BMI

Secondary Outcome Measures

distress tolerance
emotion regulation and distress tolerance(Distress Tolerance Scale)
Mood
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 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: SCID-I Substance Module Weekly during 6-week intervention: quantity, frequency, type of substance use

Full Information

First Posted
September 27, 2011
Last Updated
October 13, 2011
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT01453517
Brief Title
A Psychological and Behavioral Intervention for Post-Bariatric Patients
Official Title
Dialectical Behavior Therapy (DBT) for Post-Bariatric Patients Experiencing Weight Regain
Study Type
Interventional

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
bariatric, obesity, post-surgery, intervention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Behavioral intervention for regain after bariatric surgery
Other Intervention Name(s)
CBT-DBT intervention
Intervention Description
6 week intervention targeting dietary behavioral adherence, stress management, and distress tolerance skills to prevent weight regain
Primary Outcome Measure Information:
Title
change in weight and BMI
Time Frame
weighed at baseline and six weeks [weighed weekly during 6 week intervention]
Secondary Outcome Measure Information:
Title
distress tolerance
Description
emotion regulation and distress tolerance(Distress Tolerance Scale)
Time Frame
baseline, posttreatment (within 2 weeks of intervention completion) [measured over an average of 10-12 weeks]
Title
Mood
Description
Baseline and posttreatment measure: Structured Clinical Interview for DSM Disorders (SCID)-I Mood Module) Weekly during 6-week intervention: Beck Depression Inventory II
Time Frame
baseline, weekly during 6-week intervention, posttreatment (within 2 weeks of intervention completion)[measured over an average of 10-12 weeks]
Title
Maladaptive eating and purging
Description
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
Time Frame
baseline, weekly during 6-week intervention, posttreatment (within 2 weeks of intervention completion)[measured over an average of 10-12 weeks]
Title
Alcohol consumption
Description
Baseline: SCID-I Substance Module Weekly during 6-week intervention: quantity, frequency, type of substance use
Time Frame
Baseline, weekly during 6-week intervention,posttreatment (within 2 weeks of intervention completion) [measured over an average of 10-12 weeks]

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen Grothe, PhD, LP
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Susan Himes, PhD
Organizational Affiliation
Lifespan/Brown Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

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A Psychological and Behavioral Intervention for Post-Bariatric Patients

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