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Psychological Symptoms Among Adolescents Enrolled in a Bariatric Surgery Program

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT01079377
First received: March 2, 2010
Last updated: January 30, 2013
Last verified: January 2013
History of Changes
  Purpose

This study will examine the interaction of psychological factors and serious overweight to determine if particular patterns of psychological symptoms are helpful in predicting outcomes of weight loss surgery.

This study has two primary components:

  1. Patients from the Center of Adolescent Bariatric Surgery (CABS) program at the Morgan Stanley Children's Hospital of New York Presbyterian will be asked to participate in a longitudinal prospective study of psychopathology among severely obese adolescents (Study 1). Additionally, the psychological symptoms of this group will be compared to other treatment-seeking obese adolescents.
  2. A subset of adolescents in the CABS program enrolled in Study 1 will also be asked to participate in a study to develop and pilot test a treatment intervention delivered primarily via telemedicine (Study 2).

The investigators hypothesize that:

  1. Adolescents receiving bariatric surgery will demonstrate significant reductions in body weight, eating pathology, and other symptoms after receiving bariatric surgery.
  2. Adolescents enrolled in the bariatric surgery program will report more psychological problems than other treatment-seeking obese adolescents.
  3. Adolescents receiving the pilot pre-surgical intervention will show significant reductions in psychological symptoms (e.g., eating pathology, depressive symptoms) from pre- to post-treatment.

Condition Intervention
Obesity
 Other: Cognitive Behavioral Therapy via telemedicine intervention

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Psychological Symptoms Among Adolescents Enrolled in a Bariatric Surgery Program

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by New York State Psychiatric Institute:

Primary Outcome Measures:
  • Psychological Symptoms [ Time Frame: 8 assessment points: (1) baseline pre-surgery, (2) 2 weeks pre-surgery, (3) 3 months post-surgery, (4) 6 months post-surgery, (5) 9 months post-surgery, (6) 12 months post-surgery, (7) 18 months post-surgery, (8) 24 months post-surgery ] [ Designated as safety issue: No ]

    The measures of psychological symptoms at each time point will include:

    1. Eating and Activity Measures
    2. Depressive Symptom Measures
    3. Impulsivity Measures
    4. Measures of other relevant factors, including body mass index, family functioning, and quality of life.


Secondary Outcome Measures:
  • Treatment Compliance [ Time Frame: 8 assessment points: (1) Baseline pre-surgery, (2) 2 weeks pre-surgery, (3) 3 months post-surgery, (4) 6 months post-surgery, (5) 9 months post-surgery, (6) 12 months post-surgery, (7) 18 months post-surgery, (8) 12 months post-surgery ] [ Designated as safety issue: No ]
    Clinician rated measures of compliance and adherence to treatment recommendations.


Estimated Enrollment: 230
Study Start Date: January 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Cognitive Behavioral Therapy
CBT
 Other: Cognitive Behavioral Therapy via telemedicine intervention
A subset of adolescents from the CABS program who participate in Study 1 will be eligible to receive a pre-surgical cognitive-behavioral treatment intervention after the baseline pre-surgery assessment. The intervention will be a 12-session individual CBT, that will focus on dysregulated eating or eating pathology, emphasize behavioral techniques to allow for developmental differences among our population, and address mood and eating symptoms. The pre-surgery CBT sessions will be scheduled weekly and most will be conducted face-to-face over the internet using web-conferencing software.
Other Name: CBT

Detailed Description:

With increasing rates of overweight and obesity among children and adolescents in the United States, there is an urgent need for effective weight loss treatments for younger patients. Recently, bariatric surgery has been considered as a treatment for seriously overweight adolescents because of the potential for substantial decreases in weight and subsequent improvements in physical health. This study will examine the interaction of psychological factors and serious overweight to determine if particular patterns of psychological symptoms (psychological phenotypes) are helpful in predicting outcomes of bariatric surgery. Patients from the Center for Adolescent Bariatric Surgery (CABS) program at the Morgan Stanley Children's Hospital of New York Presbyterian will be asked to participate in a longitudinal prospective study of psychopathology among severely obese adolescents (n=180; Study 1). A subset of adolescents in the CABS program enrolled in Study 1 will also be asked to participate in a study to develop and pilot test a treatment intervention delivered primarily via telemedicine (n=30; Study 2) and/or a study to evaluate the use of a smartphone application to augment usual care and increase compliance with the nutritional and physical activity recommendations of the CABS program (n=50; Study 3). The final aim of this project is to compare psychological symptoms between obese adolescents seeking bariatric surgery, other treatment-seeking obese adolescents (n=50; Study 1), and normal-weight comparison adolescents (n=50; Study 1). Data from Studies 1, 2, & 3 will allow us to evaluate the effect of psychiatric symptoms and the treatment interventions on compliance with postsurgery follow-up appointments and weight loss. This research will be broadly applicable to the study of interactions between psychological factors and compliance with treatment for youth with chronic health conditions.

  Eligibility

Ages Eligible for Study:   14 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

STUDY 1 (Longitudinal assessments):

Inclusion Criteria:

  • enrolled in the Center for Adolescent Bariatric Surgery at the Morgan Stanley Children's Hospital of New York Presbyterian
  • between the ages of 14 and 17
  • adolescents and parents speak English

Exclusion Criteria:

  • DSM-IV diagnosis of moderate or severe mental retardation (e.g., IQ<50)

STUDY 2 (telemedicine intervention):

Inclusion Criteria:

  • adolescent meeting all inclusion and exclusion criteria for Study 1 (see above)
  • a DSM-IV diagnosis of major depressive disorder (mild or moderate depressive symptoms), dysthymia, or mood, depressive, or eating disorder not otherwise specified
  • if the adolescent does not meet criteria for inclusion #2, the presence of current clinically significant eating pathology (e.g., binge eating episodes or night eating at least twice per month) or depressive symptoms (e.g., mild to moderate scores on the DASS)
  • access to a computer with an internet connection

Exclusion Criteria:

  • DSM-IV diagnosis of mild mental retardation (e.g., IQ<70)
  • current or lifetime diagnosis of bipolar disorder, schizophrenia, other psychotic disorder, or alcohol or substance abuse or dependence
  • history of suicide attempt or gesture in which the intent was suicide or serious self harm
  • answering "yes" on question 4 (active suicidal ideation with some intent to act, without specific plan) or question 5 (active suicidal ideation with specific plan and intent) on the C-SSRS
  • acute suicidality to such a degree that precaution against suicide must be exercised
  • severe depression or major depression producing significant functional impairment
  • psychotropic medications initiated in the 4 weeks before the screening visit or a dosage change to psychiatric medications in the 2 weeks prior to screening

CONTROL GROUP (obese treatment-seeking adolescents)

Inclusion Criteria:

  • enrolled in the Maxcor Program for Overweight Education and Reduction (POWER) Program
  • Between the ages of 14 and 17
  • adolescents and parents speak English

Exclusion Criteria:

  • DSM-IV diagnosis of moderate or severe mental retardation (e.g., IQ<50)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01079377

Locations
United States, New York
New York State Psychiatric Institute
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
Investigators
Principal Investigator: Robyn Sysko, Ph.D. New York State Psychiatric Institute
  More Information

No publications provided

Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT01079377     History of Changes
Other Study ID Numbers: #6035 K23 DK088532-01A1
Study First Received: March 2, 2010
Last Updated: January 30, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by New York State Psychiatric Institute:
Adolescents
Bariatric Surgery
Psychological Symptoms
 Cognitive Behavioral Therapy
Telemedicine
Longitudinal

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

ClinicalTrials.gov processed this record on May 16, 2013