A Randomized Controlled Trial of Mental Health Outcomes and Putative Targets of an Online Mindfulness Program for New and Expectant Mothers

University of Colorado, Boulder2 个研究点分布在 1 个国家目标入组 60 人开始时间: 2018年11月16日最近更新: 2024年5月23日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: University of Colorado, Boulder
入组人数: 60
试验地点: 2
主要终点: Rate of change in anxiety symptoms

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this investigation is to conduct a randomized trial comparing a web-based Mindful Mood Balance for Moms course without coaching support to waitlist control among pregnant or early parenting women with depression histories.

详细描述

Mindfulness-based cognitive therapy (MBCT) prevents depressive relapse and reduces residual depression symptoms among adults with recurrent depression not currently in episode. Women in perinatal or early parenting years constitute a significant portion of this at-risk population with a history of depression for whom MBCT was designed. Novel delivery formats that provide access to core knowledge and skills of MBCT could increase public health impact-particularly for perinatal or early parenting women-but it is unclear whether such formats have comparable mental health outcomes and changes in putative targets as in-person MBCT.

In the present study, we planned to randomize 60 pregnant or early parenting women with a history of major depression and current residual depressive symptoms to MMB for Moms, a web-based course that teaches skills from MBCT customized specifically for pregnant and postpartum women, or waitlist control. We planned to address the following specific aims:

Aim 1. We evaluated the extent to MMB for Moms was associated with significant reduction in residual depression symptoms as compared to WLC. We predicted the rate of change in depression symptoms across the study would be greater on average for participants randomized to MMB for Moms relative to those randomized to WLC.

Aim 2. We evaluated the extent to MMB for Moms significantly engaged the putative target of decentering as compared to WLC. We predicted the rate of change in decentering across the study would be greater on average for participants randomized to MMB for Moms relative to participants randomized to WLC.

Aim 3. We evaluated the extent to MMB for Moms significantly engaged the putative target of self-compassion as compared to WLC. We predicted the rate of change in self-compassion across the study would be greater on average for participants randomized to MMB for Moms relative to participants randomized to WLC.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Other
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: 否

入选标准

•pregnant or having had a child within the past 36 months, *
•18 years of age or older,
•having a history of one or more prior major depressive episode (as assessed by a single question, "Have you had a history of mood concerns or major depression?")
•a current PHQ-9 score of <= 14, and
•endorses ability to read and write fluently in English.

排除标准

•meeting criteria for current moderately severe depression symptoms (as assessed by the PHQ-9 >= 15),
•current imminent suicidality (as assessed by the PHQ-9), and
•indication of other disorders or symptoms that necessitate priority treatment.