Text Size

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
History of Changes
  Purpose

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.


Condition Intervention
Obesity
 Behavioral: CBT
Other: educational

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Brief Group Cognitive Behavioral Therapy on Decreasing Metabolic Syndrome Risk Factors in Obese Patients Treated With Atypical Antipsychotics

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 32
Study Start Date: January 2008
Study Completion Date: March 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
6-CBT-sessions for weight loss
 Behavioral: CBT
6-CBT based sesions
Experimental: 2
Single educational intervention for weight
 Other: educational
subjects receive one hour of nutrition education and 5 weekly phone calls

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00569517

Locations
United States, Texas
Michael E. DeBakey VA Medical Center (152)
Houston, Texas, United States, 77030
Sponsors and Collaborators
Department of Veterans Affairs
Investigators
Principal Investigator: Rayan Aljurdi, MD Michael E. DeBakey VA Medical Center (152)
  More Information

No publications provided

Responsible Party: Aljurdi, Rayan - Principal Investigator, Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00569517     History of Changes
Other Study ID Numbers: H-21955, 07K19.H
Study First Received: December 5, 2007
Last Updated: March 19, 2009
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
obesity
CBT
Atypical antipsychotics
metabolic syndrome

Additional relevant MeSH terms:
Obesity
Metabolic Syndrome X
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
 Metabolic Diseases
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on June 18, 2013