Bellevue ROSE: Preventing Postpartum Depression in Prenatal Care
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Depression severity measured by Patient Health Questionnaire (PHQ-9)
研究概览
简要总结
This is randomized control trial of a brief intervention called Bellevue ROSE (Reach Out Stay Strong Essentials). Bellevue ROSE is a manualized and highly structured interpersonal intervention that provides women with psycho-education about maternal depression and strategies for strengthening social support and connectedness. Investigators use motivational interviewing strategies to improve treatment compliance and resource acquisition
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Care Provider, Investigator)
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
- •English speaking
- •Women who score between 5-19 on the PHQ-9 and >23 on the ANRQ
排除标准
- •Women who score <5 or >19 on the PHQ-9
- •Women who are currently suicidal, active substance users, currently experiencing domestic violence, or have a current or past history of bipolar or psychotic disorder diagnosis.
- •Women who are currently in treatment for psychotherapy.
- •Unable to speak and/or understand English proficiently
- •Unable to provide informed consent
研究组 & 干预措施
High Risk PTSD Group 1
Forty women who are eligible for the study will be randomized into either the Bellevue ROSE intervention (treatment group) or a psycho-education session and usual, standard of care (control group 1)
干预措施: Bellevue ROSE Intervention (Behavioral)
High Risk PTSD Group 1
Forty women who are eligible for the study will be randomized into either the Bellevue ROSE intervention (treatment group) or a psycho-education session and usual, standard of care (control group 1)
干预措施: Psycho-education session and usual, Standard of care Control (Behavioral)
High Risk PTSD Group 2
Forty women who are eligible for the study will be randomized into either the Bellevue ROSE intervention (treatment group) or a psycho-education session and usual, standard of care (control group 1)
干预措施: Bellevue ROSE Intervention (Behavioral)
High Risk PTSD Group 2
Forty women who are eligible for the study will be randomized into either the Bellevue ROSE intervention (treatment group) or a psycho-education session and usual, standard of care (control group 1)
干预措施: Psycho-education session and usual, Standard of care Control (Behavioral)
Low Risk PTSD Control
Twenty additional women, who are at lower risk and thus not eligible for randomization, will also receive one psycho-education session and usual care (control group 2).
干预措施: One Psycho-education session and usual, standard of care Control (Behavioral)
结局指标
主要结局
Depression severity measured by Patient Health Questionnaire (PHQ-9)
时间窗: 6 Months
Measure of perceived social support measured by Multidimensional Scale of Perceived Social Support (MSPSS)
时间窗: 6 Months
Measure of stress using Perceived Stress Index (PSS)
时间窗: 6 Months
Parenting Practices and treatment assessed by Parenting Practices and Treatment Questionnaire
时间窗: 6 Months
Measure of psycho social risk assessment according to Adapted antenatal Risk Questionnaire (ANRQ)
时间窗: Screening
次要结局
未报告次要终点