Practice Based Clinical Trial of Screening, Diagnosis and Follow up Management for Postpartum Depression in Family Medicine Practices.
试验速览
- 阶段
- 不适用
- 入组人数
- 3,000
- 试验地点
- 2
- 主要终点
- Level of depressive symptoms and level of parenting comfort
研究概览
简要总结
This is a study to assess the impact of introducing screening and planned follow up for postpartum depression. All women ages 18 to 45 who speak English or Spanish who come to the enrolled community family medicine offices will either be given usual care or screened using the Edinburgh Postnatal Depression Screening tool. If the EDPS score is high the women will be given the PHQ-9 to more clearly identify the specific likelihood of being depressed. Women who are determined to be depressed will be treated with medication or counseling based on the preference of the women and their physicians. Women will be followed through nurse initiated phone calls and visits to the physicians office.
Outcomes include the level of depression symptoms, measure of comfort with parenting, and satisfaction with partner relationships comparing baseline levels with those at 6 and 12 months from the usual care and intervention sites. These data will be collected by questionnaire. In addition, with the women's permission, medical records will be reviewed.
详细描述
A randomized controlled trial of screening and management of postpartum depression that includes a second phase assessing the maintenance of the intervention in the original intervention sites and a switch from usual care to intervention in the control sites.
Planned enrollment includes 29 family medicine practices and 3000 women over a period of four years. All follow up and management is initiated within the family medicine practices to improve generalizability and likelihood for dissemination.
In addition to the patient centered outcomes, exploratory analyses will look at the uptake and degree of implementation and maintenance of the intervention based on characteristics of the practice including size, location, affiliation with larger group, type of practice and whether or not the practice is a community health center or residency practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •5 to 12 weeks postpartum
- •Able to speak and read English or Spanish
- •18 to 45 years of age
排除标准
- •Significant cognitive impairment and unable to answer screening questions
结局指标
主要结局
Level of depressive symptoms and level of parenting comfort
时间窗: 12 months postpartum
次要结局
- Percent eligible women screened and of those screen positive, percent treated and followed according to protocol(12 months for each women)
