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

September 27, 2011
October 13, 2011
September 2010
August 2011   (final data collection date for primary outcome measure)
change in weight and BMI [ Time Frame: weighed at baseline and six weeks [weighed weekly during 6 week intervention] ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01453517 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
A Psychological and Behavioral Intervention for Post-Bariatric Patients
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.

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.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Obesity
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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
August 2011
August 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01453517
10-004976
No
Karen Grothe, Mayo Clinic
Mayo Clinic
Not Provided
Principal Investigator: Karen Grothe, PhD, LP Mayo Clinic
Principal Investigator: Susan Himes, PhD Lifespan/Brown Medical School
Mayo Clinic
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP