PACEPro - Mood Management Pilot

Study Overview
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Brief Summary
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Researchers at the University of California at San Diego (UCSD) are conducting a 12-week study to test the PACEPRO program. This program is designed to reduce depression by providing: Lexapro, an antidepressant medicine…Learn More Physical activity information and pedometer Mood management skills and a Mood Mastery Guide Personalized support from a Family Nurse Practitioner

Official Title
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Development and a Pilot Study of the PACEPRO Exercise and Mood Management Program in Depressed Patients on Escitalopram Oxalate (Lexapro)

Conditions
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Depression

Intervention / Treatment
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* Drug: Lexapro, an antidepressant medicine
* Behavioral: Physical Activity
* Behavioral: Mood Management Skills
* Behavioral: Personalized support from a Family Nurse Practitioner


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have been diagnosed with mild to moderate depression Are willing to take the antidepressant Lexapro Can access and use Email and the Internet Are willing and able to be physically active Access to a primary care physician Exclusion Criteria: Subjects will be excluded from participation for the following reasons: Pregnancy or breastfeeding Narrow angle glaucoma Any uncontrolled medical condition or any medical condition which would represent a contraindication to Escitalopram Oxalate Lexapro® pharmacotherapy. Any concomitant non-psychotropic medications that the physician determines are a contraindication to Escitalopram Oxalate Lexapro® pharmacotherapy Bipolar disorder, or any psychotic or organic mental disorder or dementia History of intolerance or allergy to Lexapro, or of prior failed treatment for depression with Lexapro Current substance abuse or dependency Current active suicidal ideation Current use of herbal psychoactive treatments such as St. John's Wort Concurrent psychotropic medication is not permitted for 2 weeks prior to randomization (4 weeks in the case of fluoxetine) or at any point after Receipt of formal psychotherapy concurrently Inability, in the investigator's opinion, to comply with study procedures or assessments Inability to exercise

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 65 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Lexapro, an antidepressant medicine|nan|
|Behavioral: Physical Activity|nan|
|Behavioral: Mood Management Skills|nan|
|Behavioral: Personalized support from a Family Nurse Practitioner|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement visits will be conducted at the PACE office. The specific activities to be conducted at the baseline, 6 and 12 week assessment visits are listed below. |  |  | 
| Physiological Measures |  | baseline, 6 weeks, 12 weeks | 
| Height and weight |  | baseline, 6 weeks, 12 weeks | 
| Waist & hip, circumference |  | baseline, 6 weeks, 12 weeks | 
| Blood pressure and pulse |  | baseline, 6 weeks, 12 weeks | 
| Physical activity level measured by wearing a monitor around the waist for 3 days (at baseline and 12 weeks only) |  | baseline, 6 weeks, 12 weeks | 
| Interview/Survey Measures |  | baseline, 6 weeks, 12 weeks | 
| Self report depressive symptoms |  | baseline, 6 weeks, 12 weeks | 
| Self-report of moderate and vigorous physical activity for seven days |  | baseline, 6 weeks, 12 weeks | 
| Self-report of TV viewing and recreational computer use for seven days |  | baseline, 6 weeks, 12 weeks | 
| Self-report on readiness to make changes in physical activity and mood management behaviors |  | baseline, 6 weeks, 12 weeks | 
| Personal assessment of factors related to behavior change including: self-efficacy, social support, barriers to change, and use of behavior change skills, and the environment |  | baseline, 6 weeks, 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depression, Lexapro