跳至主要内容
临床试验/NCT04680585
NCT04680585已完成不适用

Reproductive Mental Health of Ontario Virtual Intervention Network (MOVIN): A Pilot Randomized Controlled Trial

Women's College Hospital2 个研究点 分布在 1 个国家目标入组 101 人开始时间: 2021年4月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
101
试验地点
2
主要终点
Feasibility of the trial protocol: Recruitment

研究概览

简要总结

Despite available treatments for perinatal mood disorders, only 20% of affected women receive treatment that results in remission of symptoms. In order to address gaps in equitable access to treatment the investigators developed the Reproductive Mental health of Ontario Virtual Intervention Network (MOVIN), a virtual collaborative care platform to optimize access for pregnant and postpartum people in Ontario. MOVIN combines collaborative and stepped-care approaches to treatment of perinatal depression and anxiety. The overall objective of this pilot randomized controlled trial (RCT) is to determine the feasibility of implementing a protocol for studying MOVIN for pregnant and postpartum individuals with significant symptoms of depression and anxiety (EPDS > 12) in order to inform the conduct of a larger scale evaluation. O will be randomized to either the MOVIN or control condition and will be asked to complete follow-up assessments 12- and 24-weeks post-randomization. Participants in the MOVIN arm will receive access to the MOVIN platform which includes a care coordinator to help them navigate various virtual treatments. Participants in the control condition will receive a resource list and will navigate the various options on their own.

详细描述

People with scores above 12 on the EPDS have a 10 times greater likelihood of having a diagnosis of depression than those with scores with 12 or less, so this is an appropriate cut-off. The primary endpoint is at 12 weeks post-randomization and the secondary endpoint is at 24 weeks post-randomization. Randomization will be performed as block randomization (varying block sizes) with a 1:1 allocation and will be stratified based on EPDS score (13-19 vs. 20 or greater). Participants who score 12 or less on the EPDS in their initial self-referral screen will be informed that they are not at high risk for having depressive or anxiety disorder and the current time, and can re-screen as needed. Participants whose score is in the 9-12 range (i.e. those who are not likely to be experiencing a depressive or anxiety disorder requiring mental health treatment, but might benefit from additional support) will receive an automated message that communicates their score and the acknowledgment of their possible need for support, and provides a list of resources in Ontario that may be helpful for them. These participants will be invited to re-screen at any time into the study, and will be asked permission to be re-contacted in future to determine which supports they used, if any.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Feasibility of the trial protocol: Recruitment

时间窗: 12 weeks post randomization

Measures of recruitment and retention include rate of recruitment, reason for non-participation and rate of completion of follow-up measures.

Feasibility of the trial protocol: Acceptability

时间窗: 12 weeks post randomization

Measures of acceptability include participants' overall experience and satisfaction with and acceptance of the MOVIN platform and the care coordinator, the care coordinator's assessment of the MOVIN platform and its impact on patient care, and primary care providers' assessment of MOVIN's impact on patient care.

Feasibility of the trial protocol: Compliance

时间窗: 12 weeks post randomization

Measures of compliance include rate of completion of MOVIN-specific activities, rate of completion of suggested interventions, and rate of resource use.

次要结局

  • Feasibility of the trial protocol: Compliance(24 weeks post randomization)
  • Health service use: participant cost(12 and 24 weeks post randomization)
  • Care coordinator cost(12 and 24 weeks post randomization)
  • Dyadic relationship(12 and 24 weeks post randomization)
  • Feasibility of the trial protocol: Acceptability(24 weeks post randomization)
  • Feasibility of the trial protocol: Recruitment(24 weeks post randomization)
  • Maternal clinical outcomes - depression symptoms(12 and 24 weeks post randomization)
  • Care coordinator time(12 and 24 weeks post randomization)
  • Maternal clinical outcomes - anxiety symptoms(12 and 24 weeks post randomization)
  • Health service use: participant time(12 and 24 weeks post randomization)
  • Maternal child relationship(12 and 24 weeks post randomization)
  • Infant temperament(Baseline, 12 and 24 weeks post randomization)
  • Maternal clinical outcomes - quality of life(12 and 24 weeks post randomization)
  • Health service use: health system costs(12 and 24 weeks post randomization)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Simone Vigod

Chief, Department of Psychiatry

Women's College Hospital

研究点 (2)

Loading locations...

相似试验