Clinical trial NCT01453517: 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
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: bariatric
obesity
post-surgery
intervention
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2011-10-18
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: change in weight and BMI
timeFrame: weighed at baseline and six weeks [weighed weekly during 6 week intervention]
Secondary outcomes:
measure: distress tolerance
timeFrame: baseline, posttreatment (within 2 weeks of intervention completion) [measured over an average of 10-12 weeks]
measure: Mood
timeFrame: baseline, weekly during 6-week intervention, posttreatment (within 2 weeks of intervention completion)[measured over an average of 10-12 weeks]
measure: Maladaptive eating and purging
timeFrame: baseline, weekly during 6-week intervention, posttreatment (within 2 weeks of intervention completion)[measured over an average of 10-12 weeks]
measure: Alcohol consumption
timeFrame: Baseline, weekly during 6-week intervention,posttreatment (within 2 weeks of intervention completion) [measured over an average of 10-12 weeks]
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Karen Grothe, PhD, LP
role: PRINCIPAL_INVESTIGATOR
affiliation: Lifespan/Brown Medical School
name: Susan Himes, PhD
role: PRINCIPAL_INVESTIGATOR
References: