Obesity
Conditions
Keywords
obesity, CBT, Atypical antipsychotics, metabolic syndrome
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.
Interventions
BEHAVIORALCBT
6-CBT based sesions
OTHEReducational
subjects receive one hour of nutrition education and 5 weekly phone calls
Sponsors
US Department of Veterans Affairs
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
United States
Outcome results
None listed