A Psychological and Behavioral Intervention for Post-Bariatric Patients

NCT01453517 | Completed

• 1 other identifier: 10-004976
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

bariatric; obesity; post-surgery; intervention

Outcome Measures

Primary Outcomes (1)

• change in weight and BMI

  weighed at baseline and six weeks [weighed weekly during 6 week intervention]

Secondary Outcomes (4)

• distress tolerance

  baseline, posttreatment (within 2 weeks of intervention completion) [measured over an average of 10-12 weeks]

• Mood

  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

  baseline, weekly during 6-week intervention, posttreatment (within 2 weeks of intervention completion)[measured over an average of 10-12 weeks]

• Alcohol consumption

  Baseline, weekly during 6-week intervention,posttreatment (within 2 weeks of intervention completion) [measured over an average of 10-12 weeks]

Interventions

Behavioral intervention for regain after bariatric surgery BEHAVIORAL

6 week intervention targeting dietary behavioral adherence, stress management, and distress tolerance skills to prevent weight regain

Also known as: CBT-DBT intervention

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

Behavior Therapy

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Karen Grothe, PhD, LP

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

• Susan Himes, PhD

  Lifespan/Brown Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Assistant Professor

Study Record Dates

• First Submitted: September 27, 2011
• First Posted: October 18, 2011
• Study Start: September 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: October 18, 2011

Record last verified: 2011-10

Locations

US (1)