Partner-Assisted Interpersonal Psychotherapy or Antidepressant Medication for Antenatal Depression
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Hamilton Rating Scale for Depression-17 item version (HRSD-17)
研究概览
简要总结
Purpose: To compare a novel psychotherapy, Partner-Assisted Interpersonal Psychotherapy (PA-IPT), with treatment as usual (TAU) in a sample of pregnant women seeking treatment for Major Depressive Disorder (MDD) at the University of North Carolina at Chapel Hill (UNC-CH) Perinatal Psychiatry Program.
Participants: 52 women, ages 18-45, who are 16-29 weeks pregnant and experiencing a depressive episode, and their partners.
Methods: Women and their identified partners will complete a diagnostic interview, complete measures of depressive symptom severity at baseline, and be randomized to treatment with PA-IPT or TAU. Women randomized to TAU will be treated by UNC physicians according to the UNC-CH Perinatal Psychiatry Program's algorithm for treatment of prenatal MDD (usually one of a number of antidepressant medications, tailored to the individual, although some women may opt against medication altogether and still be eligible to enroll). Women randomized to PA-IPT will participate in 8 therapy sessions with their identified partner over a 12-week period, along with one refresher session at or around 6 weeks postpartum. Women and partners will be assessed for change in depressive symptoms and relationship satisfaction during pregnancy at visits 4 and 8, and postpartum at 6-week and 6-month visits.
Hypothesis: The investigators anticipate notable improvement in both groups similar in magnitude, however it is hypothesized that couples participating in PA-IPT will have higher relationship satisfaction post-treatment (controlling for baseline satisfaction) than those receiving TAU.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Females aged 18-45 years
- •16-29 weeks estimated gestational age
- •Able to provide informed consent
- •English or Spanish language literacy
- •In a committed relationship cohabiting for at least 6 months with a Dyadic Adjustment Scale rating < 90 or with an identified family member or friend residing in the same home
- •Meet criteria for Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition Text Revision (DSM-IV) diagnosis of Major Depressive Disorder (MDD)
- •HRSD-17 score is equal or greater than 16 at diagnostic evaluation and randomization
- •Medically healthy and without fetal anomaly according to history
排除标准
- •No identified primary care, nurse midwife, or obstetrical physician to monitor pregnancy; participant or physician refuses to sign release of information
- •By patient report, history of partner verbal, emotional, or physical abuse
- •Partner unable or unwilling to participate
- •DSM-IV diagnoses of bipolar 1 or 2 or any psychotic episode
- •Substance abuse within the last 6 months
- •Eating Disorder
- •Current use of other therapies for depression including individual psychotherapy, herbal remedies or other complementary/alternative therapies, antidepressant medication outside the study protocol
- •Active suicidal ideation
- •Identified partner has DSM-IV diagnoses of bipolar 1 or 2 or any psychotic episode
- •Interpersonal violence or abuse
结局指标
主要结局
Hamilton Rating Scale for Depression-17 item version (HRSD-17)
时间窗: Baseline (16-29 weeks pregnancy) until Endpoint (6 months postpartum)
Change from baseline in symptoms of Major Depressive Disorder
次要结局
- Dyadic Adjustment Scale (DAS)(Baseline (16-29 weeks pregnancy) until Endpoint (6 months postpartum))