Cognitive Behavioral Therapy for Obesity

US Department of Veterans Affairs (VA)

Status: Completed

Conditions: Obesity

Treatments: Other: educational; Behavioral: CBT

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT00569517

07K19.H

H-21955

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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32 participants in 2 patient groups

1

Experimental group

Description:

6-CBT-sessions for weight loss

Treatment:

Behavioral: CBT

2

Experimental group

Description:

Single educational intervention for weight

Treatment:

Other: educational