Development and a Pilot Study of the PACEPRO Exercise and Mood Management Program in Depressed Patients on Escitalopram Oxalate (Lexapro)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- 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.
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
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
时间窗: baseline, 6 weeks, 12 weeks
Height and weight
时间窗: baseline, 6 weeks, 12 weeks
Waist & hip, circumference
时间窗: baseline, 6 weeks, 12 weeks
Blood pressure and pulse
时间窗: 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)
时间窗: baseline, 6 weeks, 12 weeks
Interview/Survey Measures
时间窗: baseline, 6 weeks, 12 weeks
Self report depressive symptoms
时间窗: baseline, 6 weeks, 12 weeks
Self-report of moderate and vigorous physical activity for seven days
时间窗: baseline, 6 weeks, 12 weeks
Self-report of TV viewing and recreational computer use for seven days
时间窗: baseline, 6 weeks, 12 weeks
Self-report on readiness to make changes in physical activity and mood management behaviors
时间窗: 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
时间窗: baseline, 6 weeks, 12 weeks
次要结局
未报告次要终点