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

Tracking Information

First Received Date ^ICMJE

December 5, 2007

Last Updated Date

March 19, 2009

Start Date ^ICMJE

January 2008

Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00569517 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Cognitive Behavioral Therapy for Obesity

Official Title ^ICMJE

The Effect of Brief Group Cognitive Behavioral Therapy on Decreasing Metabolic Syndrome Risk Factors in Obese Patients Treated With Atypical Antipsychotics

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Obesity

Intervention ^ICMJE

Behavioral: CBT
6-CBT based sesions
Other: educational
subjects receive one hour of nutrition education and 5 weekly phone calls

Study Arm (s)

Experimental: 1
6-CBT-sessions for weight loss

Intervention: Behavioral: CBT
Experimental: 2
Single educational intervention for weight

Intervention: Other: educational

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

March 2009

Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00569517

Other Study ID Numbers ^ICMJE

H-21955, 07K19.H

Has Data Monitoring Committee

Responsible Party

Aljurdi, Rayan - Principal Investigator, Department of Veterans Affairs

Study Sponsor ^ICMJE

Department of Veterans Affairs

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Rayan Aljurdi, MD

Michael E. DeBakey VA Medical Center (152)

Information Provided By

Department of Veterans Affairs

Verification Date

March 2009

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

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