Mother Matters: Pilot Randomized Waitlist Controlled Trial of an Online Postpartum Mental Health Support Group
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Recruitment Feasibility (Eligibility)
研究概览
简要总结
Postpartum depression is common, yet only 20% of women seek treatment. Online support groups are a potential means of providing accessible mental health care during this time. Mother Matters is a 10-week online psychotherapy group for women with postpartum depression & anxiety. The investigators aim to conduct a pilot RCT to demonstrate the feasibility of proceeding to a large-scale RCT evaluation of the Mother Matters intervention.
详细描述
The postpartum period is a particularly vulnerable time for the development of mental health concerns; postpartum depression (i.e. depression with onset between 0-12 months postpartum) affects approximately 13% of mothers in Canada. There are serious negative consequences to both mother and child during this period, yet only 20% of women seek treatment, citing significant systematic and personal barriers. Online support groups have been identified as a potential means of providing accessible mental health care during this time. Mother Matters is a 10-week online support group for women with postpartum depression and anxiety, run trained psychotherapists in the Reproductive Life Stages (RLS) program at Women's College Hospital in Toronto, Ontario. Mother Matters was designed to address barriers related to accessing postpartum mental health services: it can be accessed anywhere (online group), at any time (available 24/7), and with anonymity (to address the barrier of shame/stigma). The overall objective of the current pilot RCT is to determine the feasibility of conducting a large randomized controlled trial to evaluate the efficacy of the group, comparing outcomes among those with and without access to the program.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •The specific inclusion criteria for this group are women who are:
- •Mothers of a baby/babies between 0 and 12 months old at enrollment, and
- •Over 18 years old, and
- •Have an Edinburgh Postnatal Depression Scale (EPDS) score of >9, and
- •Reside in Ontario.
排除标准
- •Women will not be eligible to participate in the study if they are:
- •Experiencing active suicidal ideation, or
- •Have active substance use, mania or psychosis, or
- •Unable to access the internet, or
- •Unable to participate in English.
研究组 & 干预措施
Immediate Treatment Condition (ITC)
Mother Matters Online Postpartum Support Group. Participants will be assigned to begin immediately after randomization.
干预措施: Mother Matters Online Postpartum Support Group (Behavioral)
Waitlist Control Condition (WLC)
Mother Matters Online Postpartum Support Group. Participants will receive the intervention after the Immediate Treatment Condition group completes the intervention, and after follow-up data are collected from both groups.
结局指标
主要结局
Recruitment Feasibility (Eligibility)
时间窗: One year from when the study starts enrolling participants
The proportion of participants eligible to participate in Mother Matters
次要结局
- Edinburgh Postnatal Depressive Scale (EPDS)(Follow-up (10 weeks post-randomization at the completion of the Mother Matters online support group for the immediate treatment condition arm))
- State-Trait Anxiety Inventory (STAI)(Follow-up (10 weeks post-randomization at the completion of the Mother Matters online support group for the immediate treatment condition arm))
- The Change in Eating Disorder Symptoms Scale (CHEDS)(Follow-up (10 weeks post-randomization at the completion of the Mother Matters online support group for the immediate treatment condition arm))
- Parenting Stress Index, Short Form (PSI)(Follow-up (10 weeks post-randomization at the completion of the Mother Matters online support group for the immediate treatment condition arm))
- Intervention Acceptability (Qualitative)(Follow-up (Immediate treatment condiction: 10 weeks post-randomization, i.e. at completion of the Mother Matters online support group; Waitlist control condition: 10 weeks after the waitlist Mother Matters group starts))
- Intervention Acceptability (Website Usage)(Follow-up (Immediate treatment condiction: 10 weeks post-randomization, i.e. at completion of the Mother Matters online support group; Waitlist control condition: 10 weeks after the waitlist Mother Matters group starts))
- Trial Protocol Adherence (Study Measure Completion)(Follow-up (about 10 weeks post-randomization))
- Recruitment Feasibility (Recruitment)(One year from when the study starts enrolling participants)
- Trial Protocol Adherence (Weekly Posting)(Follow-up (Immediate treatment condiction: 10 weeks post-randomization, i.e. at completion of the Mother Matters online support group; Waitlist control condition: 10 weeks after the waitlist Mother Matters group starts))
- Trial Protocol Adherence (Posting Drop-Off)(Follow-up (Immediate treatment condiction: 10 weeks post-randomization, i.e. at completion of the Mother Matters online support group; Waitlist control condition: 10 weeks after the waitlist Mother Matters group starts))