NCT02503670Unknown不适用
HealthyDads.Ca-Development and Pilot Evaluation of a Multimodal E-Health Intervention to Promote the Mental Health of Men at Risk for Depression
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 72
- 试验地点
- 6
- 主要终点
- Change from baseline on depressed mood as measured by the Edinburgh Postnatal Depression Scale (EPDS)
研究概览
简要总结
The purpose of this study is to develop and pilot test HealthyDads.ca, a website for expectant first-time fathers who have known risk factors for depression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Able to communicate in French or English
- •Either married or cohabiting at the time of study entry
- •First child for both partners
- •Have internet access
- •Score <12 on the Edinburgh Postnatal Depression Scale (EPDS)
- •Not currently receiving psychotherapy from a health professional or on medication for a mental disorder
- •At least 1 risk factor for depression if they score < 6 on the EPDS: a)history of depression, b) elevated anxiety or c) couple discord
排除标准
- •Suicidal ideation or intent
- •Physical condition precluding participation in exercise
结局指标
主要结局
Change from baseline on depressed mood as measured by the Edinburgh Postnatal Depression Scale (EPDS)
时间窗: Study entry, 6 weeks post randomization, 2 and 6 months following delivery
This is a widely used reliable and standardized measure of depression.
Acceptability of HealthyDads.caHealthyDads.ca measured by the Usability and Satisfaction questionnaire
时间窗: 6 weeks post randomization
To evaluate the acceptability of the internet delivered program in terms of rating on items pertaining to the website's ease of use and satisfaction.
次要结局
- Changes from baseline on emotional well-being as measured by the Mental Health Continuum-Short Form (MHC-SF)(Study entry, 6 weeks post randomization, 2 and 6 months following delivery)
- Changes from baseline on parenting stress measured by the Parenting Stress Scale (PARSS)(Study entry, 6 weeks post randomization, 2 and 6 months following delivery)
- Changes from baseline on level of physical activity participation measured by the International Physical Activity Questionnaire (IPAQ)(Study entry, 6 weeks post randomization, 2 and 6 months following delivery)
- Changes from baseline on sleep quality measured by the Pittsburgh Sleep Quality Index (PSQI)(Study entry, 6 weeks post randomization, 2 and 6 months following delivery)
- Changes from baseline on perceptions of stigma measured with the Stigma Scale for Receiving Psychological Help (SSRPH),(Study entry, 6 weeks post randomization, 2 and 6 months following delivery)
研究者
Deborah Da Costa
Associate Professor
McGill University
研究点 (6)
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