Cognitive Behavioral Therapy for Obesity

Study Overview
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Brief Summary
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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.

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

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: CBT
* Other: educational


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>6-CBT-sessions for weight loss | Behavioral: CBT<br>* 6-CBT based sesions<br>|
| Experimental: 2<br>Single educational intervention for weight | Other: educational<br>* subjects receive one hour of nutrition education and 5 weekly phone calls<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obesity, CBT, Atypical antipsychotics, metabolic syndrome