Z 31801 - A Pilot Trial of Perinatal Depression Treatment in HIV Infected Women
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Number of Women With Anxiety or Depression Based on the MINI Who Agree to Participate in the Study
研究概览
简要总结
This pilot study will evaluate, through quantitative and qualitative methods, whether different treatments for postpartum depression are feasible and acceptable in postpartum HIV infected women on antiretrovirals (ART). The study will take place at several clinics in Lusaka, Zambia.
详细描述
The standard of care for treating postpartum depression in the US is antidepressants, psychotherapy or both. Little data exist on the best method for treating perinatal depression (PND) in Sub-Saharan Africa. This is a mixed method study including a pilot randomized controlled trial (RCT) of antidepressant medication (ADM) versus interpersonal psychotherapy (IPT) and qualitative semi-structured interviews (SSIs). The study will enroll 100 pregnant HIV infected women over the age of 18 seeking postnatal care and continuing antiretroviral therapy in pregnancy. An additional 20 women enrolled in the RCT will be invited to participate in SSIs. Each participant will be followed for 24 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Antidepressant medication
Daily self-administered selective serotonin reuptake inhibitor (SSRI) Sertraline 25 mg table
干预措施: Sertraline (Drug)
Interpersonal therapy
Up to 11 planned therapy sessions over a 24-week period beginning the day of randomization
干预措施: Interpersonal therapy (Behavioral)
结局指标
主要结局
Number of Women With Anxiety or Depression Based on the MINI Who Agree to Participate in the Study
时间窗: 6-8 weeks postpartum
MINI International Neuropsychiatric Interview (MINI) is a brief structured diagnostic interview and is designed to assess the most common psychiatric disorders in ICD-10 and DSM-5. MINI modules were used: major depressive disorder and generalized anxiety disorder. Questions are rated dichotomously (yes/no) and clinical judgment should be used in coding the responses, asking for examples if needed. Participants will be eligible for the study if they are diagnosed with depression or anxiety based on the MINI assessment.
Number of Women Retained in the Study
时间窗: Enrollment - final visit, approximately 24 weeks after enrollment
Number of women who are enrolled in the study who complete the final study visit
Number of Women Approached Who Agreed to Pre-Screening With EPDS
时间窗: 2-7 weeks postpartum
In order to determine feasibility, the number of women who agree to be pre-screened with the Edinburgh Postnatal Depression Screen (EPDS) within 2-7 weeks postpartum
Number of Women Pre-Screened Who Have an EPDS Score >/= 6
时间窗: 2-7 weeks postpartum
The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item self-report used to measure postpartum depression with score range 0-30, a higher score indicates greater symptom burden. A score of \>/= 6 is indicative of a woman being at risk of perinatal depression. The number of women with an EPDS \>/= 6 out of all of the women who were pre-screened with an EPDS.
Number of Women With an EPDS >/= to 6 Who Were Consented and Underwent Diagnostic Testing With MINI
时间窗: 2-7 weeks postpartum
MINI International Neuropsychiatric Interview (MINI) is a brief structured diagnostic interview and is designed to assess the most common psychiatric disorders in ICD-10 and DSM-5. MINI modules were used: major depressive disorder and generalized anxiety disorder. Questions are rated dichotomously (yes/no) and clinical judgment should be used in coding the responses, asking for examples if needed. Participants will be eligible for the study if they are diagnosed with depression or anxiety based on the MINI assessment. After pre screening with an EPDS, women with an EPDS \>/=6 were invited to undergo MINI diagnostic testing after signed consent.
次要结局
- Number of Women With a CGI Score Decline of One Point From Baseline(Enrollment - final visit, approximately 24 weeks after enrollment)
- Percentage of Women Who Adhere to the Prescribed Antidepressant Medication (ADM)(Enrollment - final visit, approximately 24 weeks after enrollment)
- Changes in the Viral Load Between Study Entry and the Last Visit(Enrollment - final visit, approximately 24 weeks after enrollment)
- Percentage of Women Experiencing Anti Depressant Medication Toxicity(Enrollment - final visit, approximately 24 weeks after enrollment)
- Acceptability of Trial Participation for Treatment of Postpartum Depression(Enrollment - final visit, approximately 24 weeks after enrollment)
- Number of Women With an EPDS Score Decline of 3 Points From Baseline(Enrollment - final study visit, approximately 24 weeks after enrollment)
- Number of Women Who Adhere to the Interpersonal Therapy Arm (IPT)(Enrollment - final visit, approximately 24 weeks after enrollment)