Group Cognitive Behavioural Therapy for Paternal Perinatal Depression: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Paternal Perinatal Depression Symptoms - Edinburgh Postnatal Depression Scale (EPDS)
研究概览
简要总结
The purpose of the proposed study is to determine the effectiveness of an online, 9-week group cognitive behavioural therapy (CBT) intervention for paternal perinatal depression (PND) in fathers and fathers-to-be. Fathers or fathers-to-be living in Ontario, Canada who have depression symptoms while their partner has been pregnant and/or during the first 18 months of their child's life will be assigned with a 50/50 chance (like flipping a coin) to receive online group CBT in addition to usual care, or to receive usual care only.
详细描述
This study will involve a randomized controlled trial (RCT) to determine the effectiveness of a 9-week group CBT intervention added to treatment as usual (TAU) compared to TAU alone for improving paternal perinatal depression symptoms. The primary objective is to determine the effectiveness of the intervention for treating paternal perinatal depression symptoms, and secondary objectives will assess whether the intervention leads to improvements in common comorbidities (anxiety) and complications (parenting stress, social isolation, partner relationship quality, parent-infant attachment, and offspring behaviour) and whether it is cost-effective.
112 participants will be assigned in a 1:1 ratio to the experimental or control group. Participants in both groups will complete online questionnaires and structured telephone interviews at baseline (T1), 9 weeks later (T2 - immediately post-intervention in the experimental group) and 6 months post-enrollment (T3). Those assigned to receive the 9-week CBT group will also be asked questions about their satisfaction with the program and recommendations for improvement.
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
Participants and the research coordinator cannot be blinded to group condition though the research assistants making reminder calls and data analysts will not be aware of group status.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Non-birthing individuals identifying as fathers-to-be (i.e., have a pregnant partner) or fathers who have an infant <18 months at recruitment
- •Fluent in written/spoken English
- •Have an EPDS score ≥9
- •Live in Ontario
排除标准
- •Free of bipolar, psychotic, borderline personality and current substance use disorders
研究组 & 干预措施
Control/Usual Care
Participants randomized to the No Intervention group will continue to receive treatment as usual (standard care). A list of resources will be emailed.
9-Week Group Cognitive Behavioural Therapy Intervention
The experimental group will receive a 9-week group CBT intervention in addition to receiving treatment as usual.
干预措施: Cognitive Behavioral Therapy for Paternal Perinatal Depression (Behavioral)
结局指标
主要结局
Paternal Perinatal Depression Symptoms - Edinburgh Postnatal Depression Scale (EPDS)
时间窗: 9 weeks
The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item gold standard measure of PND. Total scores range from 0-30 with higher scores indicating worse depressive symptoms. A score of ≥10 is consistent with possible PND, ≥13 is consistent with probable PND and changes in scores \>4 are accepted as being indicative of clinically significant change.
Paternal Perinatal Depression (PND) Symptoms - Edinburgh Postnatal Depression Scale (EPDS)
时间窗: 9 weeks
The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item gold standard measure of perinatal depression (PND). Total scores range from 0-30 with higher scores indicating worse depressive symptoms. A score of ≥10 is consistent with possible PND, ≥13 is consistent with probable PND and changes in scores \>4 are accepted as being indicative of clinically significant change.
次要结局
- Paternal Perinatal Depression Symptoms - Edinburgh Postnatal Depression Scale (EPDS)(6 months post enrollment)
- Anxiety Symptoms - GAD-7(9 weeks)
- Anxiety Symptoms - GAD-7(6 months post enrollment)
- Parenting Stress - Parenting Stress Index Short Form (PSI-SF)(9 weeks)
- Parenting Stress - Parenting Stress Index Short Form (PSI-SF)(6 months post enrollment)
- Partner Relationship Quality - Dyadic Adjustment Scale (DAS)(9 weeks)
- Partner Relationship Quality - Dyadic Adjustment Scale (DAS)(6 months post enrollment)
- Parent-Infant Bonding - Postpartum Bonding Questionnaire (PBQ)(9 weeks)
- Parent-Infant Bonding - Postpartum Bonding Questionnaire (PBQ)(6 months post enrollment)
- Infant Temperament - Infant Behaviour Questionnaire Revised Very Short Form (IBQ-R)(9 weeks)
- Infant Temperament - Infant Behaviour Questionnaire Revised Very Short Form (IBQ-R)(6 months post enrollment)
- Depression Symptoms - Patient Health Questionnaire-9 (PHQ-9)(9 weeks)
- Depression Symptoms - Patient Health Questionnaire-9 (PHQ-9)(6 months post enrollment)
- Cost-effectiveness - Healthcare Resource Utilization(9 weeks)
- Cost-effectiveness - Healthcare Resource Utilization(6 months post enrollment)
- Major Depressive Disorder(9 weeks)
- Major Depressive Disorder(6 months post enrollment)
- Cost-effectiveness analysis - Quality Adjusted Life Year (QALY)(9 weeks)
- Cost-effectiveness analysis - Quality Adjusted Life Year (QALY)(6 months post enrollment)
研究者
Ryan Van Lieshout, MD, PhD
Professor
McMaster University