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Completed

NCT Number: NCT01453517

A Psychological and Behavioral Intervention for Post-Bariatric Patients

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.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: CBT-DBT intervention

Primary outcomes

  1. change in weight and BMI

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

Secondary outcomes

  1. distress tolerance

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

    emotion regulation and distress tolerance(Distress Tolerance Scale)

  2. Mood

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

    Baseline and posttreatment measure: Structured Clinical Interview for DSM Disorders (SCID)-I Mood Module) Weekly during 6-week intervention: Beck Depression Inventory II

  3. 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]

    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

  4. 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]

    Baseline: SCID-I Substance Module Weekly during 6-week intervention: quantity, frequency, type of substance use

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Dialectical Behavior Therapy (DBT) for Post-Bariatric Patients Experiencing Weight Regain

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Oct 18, 2011
Registry last updated
Oct 18, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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