PACEPro - Mood Management Pilot

Not Applicable

Completed

• Conditions: Depression

• Registration Number: NCT00416221
• Lead Sponsor: University of California, San Diego

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04
• Study First Submitted: 2006-12-22
• Study First Submitted QC: 2006-12-26
• Study First Posted: 2006-12-27
• Study Completion: 2007-01
• Status Verified: 2011-08
• Last Update Submitted: 2011-08-17
• Last Update Posted: 2011-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

UCSD Professional Building; 🇺🇸 La Jolla, California, United States