Cognitive Behavioral Therapy for Obesity - Full Text View

Sponsored by:	Department of Veterans Affairs
Information provided by:	Department of Veterans Affairs
ClinicalTrials.gov Identifier:	NCT00569517

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

MedlinePlus related topics: Obesity

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:	The Effect of Brief Group Cognitive Behavioral Therapy on Decreasing Metabolic Syndrome Risk Factors in Obese Patients Treated With Atypical Antipsychotics

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
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 6-CBT-sessions for weight loss	Behavioral: CBT 6-CBT based sessions
2: Experimental 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:

Age 18 years and above
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
Body Mass Index (BMI) greater than 30
Ability to consent to treatment, determined by the patient's treating/referring physician

Exclusion Criteria:

Patients with premorbid medical problems that preclude involvement in a weight loss program
Active substance abuse or dependence, indicated by a positive urine drug screen in the last 3 months
Mini-Mental Status Exam (MMSE) less than 24
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
Active major depressive episode, determined by administration of HAM-D greater than 13
Patients taking any medications for weight loss or currently enrolled in a weight loss program
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

Responsible Party:	Department of Veterans Affairs ( Aljurdi, Rayan - Principal Investigator )
Study ID Numbers:	H-21955, 07K19.H
Study First Received:	December 5, 2007
Last Updated:	October 2, 2008
ClinicalTrials.gov Identifier:	NCT00569517
Health Authority:	United States: Federal Government

Keywords provided by Department of Veterans Affairs:

obesity
CBT
Atypical antipsychotics
metabolic syndrome

Study placed in the following topic categories:

Body Weight
Signs and Symptoms
Obesity

Nutrition Disorders
Overweight
Overnutrition

ClinicalTrials.gov processed this record on January 15, 2009