Cognitive Behavioral Therapy for Obesity

This study has been completed.
Sponsor:
Information provided by:
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00569517
First received: December 5, 2007
Last updated: March 19, 2009
Last verified: March 2009

December 5, 2007
March 19, 2009
January 2008
December 2008   (final data collection date for primary outcome measure)
The accessibility to overweight outpatients with stable psychotic or mood disorders, currently treated with atypical antipsychotics willing to participate in a research study involving CBT. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
The accessibility to overweight outpatients with stable psychotic or mood disorders, currently treated with atypical antipsychotics willing to participate in a research study involving CBT. [ Time Frame: 3 months ]
Complete list of historical versions of study NCT00569517 on ClinicalTrials.gov Archive Site
Measure outcome parameters; body mass index, total cholesterol, low-density lipoproteins, triglycerides, fasting blood sugar, waist circumference, blood pressure & pulse among patients receiving CBT treatment or usual care at baseline, 6 wks & 12 wks. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Measure outcome parameters; body mass index, total cholesterol, low-density lipoproteins, triglycerides, fasting blood sugar, waist circumference, blood pressure & pulse among patients receiving CBT treatment or usual care at baseline, 6 wks & 12 wks. [ Time Frame: 3 months ]
Not Provided
Not Provided
 
Cognitive Behavioral Therapy for Obesity
The Effect of Brief Group Cognitive Behavioral Therapy on Decreasing Metabolic Syndrome Risk Factors in Obese Patients Treated With Atypical Antipsychotics

The purpose of this pilot study is to assess patient accessibility, interest and response in order to design an adequately powered study to compare brief, group cognitive behavioral therapy (CBT) for weight loss to usual care in non-demented patients above the age of 18 years old who are currently taking atypical antipsychotic medications. This pilot study is necessary, with current limitations of data in this area, to design an adequately powered study to address the difficulties managing metabolic syndrome risk factors in patients on antipsychotics.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Obesity
  • Behavioral: CBT
    6-CBT based sesions
  • Other: educational
    subjects receive one hour of nutrition education and 5 weekly phone calls
  • Experimental: 1
    6-CBT-sessions for weight loss
    Intervention: Behavioral: CBT
  • Experimental: 2
    Single educational intervention for weight
    Intervention: Other: educational
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
March 2009
December 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Age 18 years and above
  2. Patients with diagnosis of schizophrenia, schizoaffective disorder or bipolar disorder determined by assessment with chart review, currently taking at least one atypical antipsychotic, started at least 2 months prior to randomization
  3. Body Mass Index (BMI) greater than 30
  4. ability to consent to treatment, determined by the patient's treating/referring physician

Exclusion Criteria:

  1. Patients with premorbid medical problems that preclude involvement in a weight loss program
  2. Active substance abuse or dependence, indicated by a positive urine drug screen in the last 3 months
  3. Mini- Mental Status Exam (MMSE) less than 24
  4. active psychosis or mania, determined by administration of the PANSS score greater than 3 on the following items; delusions, conceptual disorganization, hallucinatory behavior, blunted affect, social withdrawal, lack of spontaneity and conversation flow, mannerisms and posturing, and unusual thought content, and YMRS greater than 10, respectively
  5. active major depressive episode, determined by administration of HAM-D greater than 13
  6. patients taking any medications for weight loss or currently enrolled in a weight loss program
  7. changes in medication regimen for diabetes or dyslipidemia within the last 3 months
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00569517
H-21955, 07K19.H
No
Aljurdi, Rayan - Principal Investigator, Department of Veterans Affairs
Department of Veterans Affairs
Not Provided
Principal Investigator: Rayan Aljurdi, MD Michael E. DeBakey VA Medical Center (152)
Department of Veterans Affairs
March 2009

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