A Psychological and Behavioral Intervention for Post-Bariatric Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Karen Grothe, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01453517
First received: September 27, 2011
Last updated: October 13, 2011
Last verified: October 2011
  Purpose

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.


Condition Intervention
Obesity
Behavioral: Behavioral intervention for regain after bariatric surgery

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Dialectical Behavior Therapy (DBT) for Post-Bariatric Patients Experiencing Weight Regain

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • change in weight and BMI [ Time Frame: weighed at baseline and six weeks [weighed weekly during 6 week intervention] ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • distress tolerance [ Time Frame: baseline, posttreatment (within 2 weeks of intervention completion) [measured over an average of 10-12 weeks] ] [ Designated as safety issue: No ]
    emotion regulation and distress tolerance(Distress Tolerance Scale)

  • Mood [ Time Frame: baseline, weekly during 6-week intervention, posttreatment (within 2 weeks of intervention completion)[measured over an average of 10-12 weeks] ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: baseline, weekly during 6-week intervention, posttreatment (within 2 weeks of intervention completion)[measured over an average of 10-12 weeks] ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, weekly during 6-week intervention,posttreatment (within 2 weeks of intervention completion) [measured over an average of 10-12 weeks] ] [ Designated as safety issue: No ]
    Baseline: SCID-I Substance Module Weekly during 6-week intervention: quantity, frequency, type of substance use


Enrollment: 26
Study Start Date: September 2010
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    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
    Other Name: CBT-DBT intervention
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01453517

Locations
United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Karen Grothe, PhD, LP Mayo Clinic
Principal Investigator: Susan Himes, PhD Lifespan/Brown Medical School
  More Information

No publications provided

Responsible Party: Karen Grothe, Principal Investigator, Assistant Professor, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01453517     History of Changes
Other Study ID Numbers: 10-004976
Study First Received: September 27, 2011
Last Updated: October 13, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
bariatric
obesity
post-surgery
intervention

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014