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Group CBT for Paternal Perinatal Depression

2026年8月11日 更新者：Ryan Van Lieshout, MD, PhD、McMaster University

Group Cognitive Behavioural Therapy for Paternal Perinatal Depression: A Randomized Controlled Trial

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.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (估计的)

112

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名：Ryan J Van Lieshout, MD, PhD
  • 电话号码：35123 (905) 522-1155
  • 邮箱：vanlierj@mcmaster.ca

学习地点

  • 加拿大
    • Ontario
      • Hamilton、Ontario、加拿大、L8S4L8
        • McMaster University
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Free of bipolar, psychotic, borderline personality and current substance use disorders

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：双倍的

武器和干预

参与者组/臂
干预/治疗
无干预：控制/通常的护理
随机分配给无干预组的参与者将继续照常接受治疗（标准护理）。 将通过电子邮件发送资源列表。
实验性的：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.
行为的：父亲围产期抑郁症的认知行为疗法
认知行为疗法（CBT）是一种心理治疗（谈话疗法）。 每周的小组会议将为两个小时，并且连续9周举行一次。 会议的第一个小时将涉及CBT技能的教学和实践，然后进行一个小时的非结构化讨论，围绕与父亲围产期抑郁症的参与者有关的主题。 每个小组将通过Zoom在线交付，并在我们的干预手册的指导下进行。

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Paternal Perinatal Depression (PND) Symptoms - Edinburgh Postnatal Depression Scale (EPDS)
大体时间：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.
9 weeks

次要结果测量

结果测量
措施说明
大体时间
Paternal Perinatal Depression Symptoms - Edinburgh Postnatal Depression Scale (EPDS)
大体时间：6 months post enrollment
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.
6 months post enrollment
Anxiety Symptoms - GAD-7
大体时间：9 weeks
The Generalized Anxiety Disorder 7-Item Scale (GAD-7) will be used to assess anxiety symptoms. The GAD-7 is a 7-item self-report scale that assesses the symptoms of generalized anxiety disorder, the most common comorbidity of PND. Items are scored on a 0-3 point scale with total scores ranging from 0-21. Higher scores indicate more severe anxiety symptoms.
9 weeks
Anxiety Symptoms - GAD-7
大体时间：6 months post enrollment
The Generalized Anxiety Disorder 7-Item Scale (GAD-7) will be used to assess anxiety symptoms. The GAD-7 is a 7-item self-report scale that assesses the symptoms of generalized anxiety disorder, the most common comorbidity of PND. Items are scored on a 0-3 point scale with total scores ranging from 0-21. Higher scores indicate more severe anxiety symptoms.
6 months post enrollment
Parenting Stress - Parenting Stress Index Short Form (PSI-SF)
大体时间：9 weeks
A 36-item self-report measure of parenting stress. Items are scored on a 1-5 point scale with total scores ranging from 36-180. Higher scores indicate greater parenting stress.
9 weeks
Parenting Stress - Parenting Stress Index Short Form (PSI-SF)
大体时间：6 months post enrollment
A 36-item self-report measure of parenting stress. Items are scored on a 1-5 point scale with total scores ranging from 36-180. Higher scores indicate greater parenting stress.
6 months post enrollment
Partner Relationship Quality - Dyadic Adjustment Scale (DAS)
大体时间：9 weeks
A 32-item self-report measure assessing partner relationship quality. Items are rated on a 5-, 6-, or 7-point scale or yes/no response. Total scores range from 0-151, with higher scores indicating better relationship adjustment and quality.
9 weeks
Partner Relationship Quality - Dyadic Adjustment Scale (DAS)
大体时间：6 months post enrollment
A 32-item self-report measure assessing partner relationship quality. Items are rated on a 5-, 6-, or 7-point scale or yes/no response. Total scores range from 0-151, with higher scores indicating better relationship adjustment and quality.
6 months post enrollment
Parent-Infant Bonding - Postpartum Bonding Questionnaire (PBQ)
大体时间：9 weeks
A 25-item self-report measure; each item is scored on a 0-5-point scale. Total scores range from 0-125 with higher scores indicating greater impairment in bonding. Subscales include: Impaired Boding, Rejection and Anger, Infant-Focused Anxiety, Risk of Abuse.
9 weeks
Parent-Infant Bonding - Postpartum Bonding Questionnaire (PBQ)
大体时间：6 months post enrollment
A 25-item self-report measure; each item is scored on a 0-5-point scale. Total scores range from 0-125 with higher scores indicating greater impairment in bonding. Subscales include: Impaired Boding, Rejection and Anger, Infant-Focused Anxiety, Risk of Abuse.
6 months post enrollment
Infant Temperament - Infant Behaviour Questionnaire Revised Very Short Form (IBQ-R)
大体时间：9 weeks
A 37 self-report measure. Each item is scored on a 7-point likert scale, with 'does not apply' option available. Mean scores of items responded to are generated for each subscale. Higher scores indicate higher levels of the measured temperament trait. Subscales assessed include Positive Affectivity/Surgency, Negative Emotionality, Orienting/Regulatory Capacity.
9 weeks
Infant Temperament - Infant Behaviour Questionnaire Revised Very Short Form (IBQ-R)
大体时间：6 months post enrollment
A 37 self-report measure. Each item is scored on a 7-point likert scale, with 'does not apply' option available. Mean scores of items responded to are generated for each subscale. Higher scores indicate higher levels of the measured temperament trait. Subscales assessed include Positive Affectivity/Surgency, Negative Emotionality, Orienting/Regulatory Capacity.
6 months post enrollment
Depression Symptoms - Patient Health Questionnaire-9 (PHQ-9)
大体时间：9 weeks
A 9-item self-report measure assessing depression symptoms. Each item is scored on a 0-3-point scale with total scores ranging from 0-27. Higher scores indicate more severe depressive symptoms.
9 weeks
Depression Symptoms - Patient Health Questionnaire-9 (PHQ-9)
大体时间：6 months post enrollment
A 9-item self-report measure assessing depression symptoms. Each item is scored on a 0-3-point scale with total scores ranging from 0-27. Higher scores indicate more severe depressive symptoms.
6 months post enrollment
Cost-effectiveness - Healthcare Resource Utilization
大体时间：9 weeks
To inform cost-effectiveness analysis, healthcare resource utilization data will be collected using a questionnaire used in prior work and adapted for the postpartum period (based on the Canadian Community Health Survey and Service Use and Resources Form). Participants will provide information on all healthcare service and medication use over the trial period.
9 weeks
Cost-effectiveness - Healthcare Resource Utilization
大体时间：6 months post enrollment
To inform cost-effectiveness analysis, healthcare resource utilization data will be collected using a questionnaire used in prior work and adapted for the postpartum period (based on the Canadian Community Health Survey and Service Use and Resources Form). Participants will provide information on all healthcare service and medication use over the trial period.
6 months post enrollment
Major Depressive Disorder
大体时间：9 weeks
DSM-5-defined current major depressive disorder (MDD) using the Diagnostic Assessment Research Tool (DART), a structured diagnostic interview.
9 weeks
Major Depressive Disorder
大体时间：6 months post enrollment
DSM-5-defined current major depressive disorder (MDD) using the Diagnostic Assessment Research Tool (DART), a structured diagnostic interview.
6 months post enrollment
Cost-effectiveness analysis - Quality Adjusted Life Year (QALY)
大体时间：9 weeks
To inform cost-effectiveness analysis, the EQ-5D-5L will be collected. This is a utility-based health-related quality of life instrument assessing five domains (mobility, self-care, usual activities, pain, depression/anxiety) and will be administered at T1-T3. The Canadian algorithm will be used to convert responses to health utility. QALYs will be calculated by multiplying the health utility for the corresponding time period (i.e., area under the curve approach).
9 weeks
Cost-effectiveness analysis - Quality Adjusted Life Year (QALY)
大体时间：6 months post enrollment
To inform cost-effectiveness analysis, the EQ-5D-5L will be collected. This is a utility-based health-related quality of life instrument assessing five domains (mobility, self-care, usual activities, pain, depression/anxiety) and will be administered at T1-T3. The Canadian algorithm will be used to convert responses to health utility. QALYs will be calculated by multiplying the health utility for the corresponding time period (i.e., area under the curve approach).
6 months post enrollment

其他结果措施

结果测量
措施说明
大体时间
Satisfaction with the intervention - Client Satisfaction Questionnaire (CSQ-8)
大体时间：9 weeks (immediately post treatment in intervention group)
Intervention participants only. Satisfaction with the intervention will be assessed using the eight-item Client Satisfaction Questionnaire (CSQ-8). The CSQ-8 consists of eight items assessing the level of satisfaction with the intervention on a 4-point Likert-type scale, as well as one open-ended question. Responses to the open-ended question will be analyzed using content analysis to inform acceptability of the intervention.
9 weeks (immediately post treatment in intervention group)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

McMaster University

合作者

Ottawa Public Health

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年9月15日

初级完成 (估计的)

2029年12月31日

研究完成 (估计的)

2029年12月31日

研究注册日期

首次提交

2026年8月6日

首先提交符合 QC 标准的

2026年8月6日

首次发布 (实际的)

2026年8月11日

研究记录更新

最后更新发布 (实际的)

2026年8月13日

上次提交的符合 QC 标准的更新

2026年8月11日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 20403

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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