Cognitive Behavioral Therapy for Obesity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00569517
Recruitment Status : Completed
First Posted : December 7, 2007
Last Update Posted : March 20, 2009
Information provided by:
VA Office of Research and Development

Brief Summary:
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 or disease Intervention/treatment Phase
Obesity Behavioral: CBT Other: educational Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : January 2008
Actual Primary Completion Date : December 2008
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00569517

United States, Texas
Michael E. DeBakey VA Medical Center (152)
Houston, Texas, United States, 77030
Sponsors and Collaborators
VA Office of Research and Development
Principal Investigator: Rayan Aljurdi, MD Michael E. DeBakey VA Medical Center (152)

Responsible Party: Aljurdi, Rayan - Principal Investigator, Department of Veterans Affairs Identifier: NCT00569517     History of Changes
Other Study ID Numbers: H-21955
First Posted: December 7, 2007    Key Record Dates
Last Update Posted: March 20, 2009
Last Verified: March 2009

Keywords provided by VA Office of Research and Development:
Atypical antipsychotics
metabolic syndrome

Additional relevant MeSH terms:
Nutrition Disorders
Body Weight
Signs and Symptoms
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs