Public Health Nurse-Peer Co-Delivered Group Cognitive Behavioral Therapy for Postpartum Depression: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 170
- 试验地点
- 2
- 主要终点
- Postpartum Depression
研究概览
简要总结
The purpose of this study is to determine the effectiveness of an online 9-week group Cognitive Behavioural Therapy (CBT; a type of talking therapy) intervention that is co-led by public health nurses (PHNs) and individuals who have previously recovered (i.e., lay peers) from postpartum depression (PPD) for treating PPD when delivered in addition to treatment as usual (TAU) compared to TAU alone. The study will also assess the impact of the intervention on common comorbidities (anxiety) and complications (parenting stress, mother-infant relationship, social support, and infant temperament) of PPD and whether it is cost-effective.
详细描述
The primary objective of the Randomized Controlled Trial (RCT) is to determine if a 9-week group Cognitive Behavioral Therapy (CBT) intervention delivered online and co-led by public health nurses (PHNs) and peers added to treatment as usual (TAU) can improve postpartum depression (PPD) more than TAU alone. Peers are individuals who have previously recovered from PPD and received training to deliver the intervention. The secondary objective of the RCT is to determine if the intervention can effectively treat its common comorbidities (anxiety) and complications (parenting stress, social support, mother-infant relationship, and infant temperament) and whether the intervention is cost-effective. 170 mothers/birthing parents will take part in the study with 50% being randomly assigned to the intervention group. All participants complete online questionnaires at 3 time points: baseline (T1), 9 weeks later (T2-immediately post-intervention in the experimental group to assess effectiveness) and 6 months later (T3-intervention durability).
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
- Double (Investigator, Outcomes Assessor)
盲法说明
Data analysts will be blinded. Data is deidentified and a study ID number is assigned. Research assistants following up with T2 and T3 questionnaires and phone interviews will be blinded.
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
- •Mothers or birthing parents, 18 years old, have an infant under 12 months of age at recruitment, fluent in written/spoken English, have a Edinburgh Postnatal Depression Scale (EPDS) score ≥10 and live in Ontario, Canada.
排除标准
- •Bipolar, psychotic, or current substance use disorders and borderline personality disorder as assessed during screening when study coordinator administers the Mini International Neuropsychiatric Interview (MINI).
结局指标
主要结局
Postpartum Depression
时间窗: 6 months (durability of intervention effects)
PPD is best conceptualized as a continuous construct with its impact operating across a continuum of severity. The primary outcome is change in PPD symptoms 6 months later (i.e., to assess durability of intervention effects). This will be measured using the Edinburgh Postnatal Depression Scale (EPDS), a gold standard measure of PPD symptoms used commonly in research and clinical settings. The EPDS has 10 items scored on a scale 0-3. Scores range from 0-30, with higher scores indicating more severe depression symptoms. The EPDS will be examined as a continuous outcome. Changes in score of 4 or more points is considered clinically meaningful improvement.
Major Depressive Disorder
时间窗: 6 months (durability of intervention effects)
We will compare DSM-5-defined major depressive disorder (MDD) using the Mini International Neuropsychiatric Interview (MINI). This interview will be administered by telephone at T2-T3. Symptoms must be present every day or nearly every day for a period of at least 2 weeks and include at least one of: depressed mood most of the day, markedly diminished interest or pleasure in all or almost all activities. There must be a total of five symptoms including the previous two criteria and the following five criteria: significant unintentional weight change or appetite change; insomnia or hypersomnia; psychomotor agitation or retardation; fatigue; feelings of worthlessness or inappropriate or excessive guilt; decreased ability to concentrate or make decisions; recurrent thoughts of death or suicidal ideation.
次要结局
- Postpartum Anxiety(6 months (durability of intervention effects))
- Parenting Stress(6 months (durability of intervention effects))
- Healthcare Resource Utilization Questionnaire(6 months (durability of intervention effects))
- Other Psychiatric Disorders(6 months (durability of intervention effects))
- Social Support(6 months (durability of intervention effects))
- Infant Temperament(9 weeks (post treatment/intervention))
- Mother-Infant Relationship(6 months (durability of intervention effects))
- EQ-5D-5L(6-month (durability of intervention effects))
研究者
Ryan Van Lieshout, MD, PhD
Professor
McMaster University