Skip to main content
OpenTrials
Completed

NCT Number: NCT00569517

Cognitive Behavioral Therapy for Obesity

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Obesity Body Weight Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Michael E. DeBakey VA Medical Center (152)

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CBT

Behavioral

6-CBT based sesions

educational

Other

subjects receive one hour of nutrition education and 5 weekly phone calls

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

US Department of Veterans Affairs

Fed

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2008
Study completion
2009
First posted
Dec 7, 2007
Registry last updated
Mar 20, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.