Phase Two: A Pilot Randomized Trial of Mindfulness-Based Cognitive Therapy for the Prevention of Perinatal Depressive Relapse/Recurrence
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 8
- 主要终点
- MBCT-PD Adherence Scale (MBCT-PD-AS)
研究概览
简要总结
Pregnant women with histories of depression are at high risk of depressive relapse/recurrence during the perinatal period, and options for relapse/recurrence prevention are limited. Mindfulness-based cognitive therapy (MBCT) has strong evidence among general populations but has not been studied among at risk pregnant women.
This study is the second phase of a multi-phase project adapting MBCT for perinatal women (MBCT-PD).
详细描述
Mindfulness-based cognitive therapy (MBCT) represents one of the most important recent developments in the effort to prevent recurrent depression. Explicitly designed to modify core underlying vulnerability factors among recovered individuals with histories of depression, MBCT may have high applicability to the prevention of perinatal depression (PD).
During this phase of the project the investigators will conduct a two-site pilot randomized clinical trial with pregnant women at high-risk of perinatal depression, comparing the efficacy of MBCT-PD to a control group in the prevention of depressive relapse and recurrence. Participants assigned to the control group will receive "ongoing assessment and referral" (OAR), consisting of routine screening and referral to behavioral health services within obstetric clinical settings within Kaiser Permanente (KP) in Colorado and Georgia. The investigators will randomly assign participants at each site to 8 weeks of MBCT-PD or OAR.
During this phase, the investigators will address the following aims:
- Specific Aim 1: To test the primary hypothesis that participants receiving MBCT-PD will experience improved depressive outcomes compared to participants receiving OAR, including lower rates of depressive relapse/recurrence and lower depressive symptom severity as compared to participants receiving OAR.
- Specific Aim 2: To explore the secondary hypotheses that participants receiving MBCT-PD will report improved functioning as compared to participants receiving OAR on a range of secondary outcomes, including indices of anxiety and stress and obstetrical complications.
- Specific Aim 3: To explore potential moderators and mediators of depression outcomes.
- Specific Aim 4: To train and evaluate the ability of behavioral health care providers to administer the MBCT-PD program with fidelity.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant up to 32 weeks gestation
- •Meeting criteria for prior depression
- •Failure to meet criteria for a diagnosis of MDD in the last two months
- •Available for group intervention scheduled meetings
排除标准
- •Presence of schizophrenia or schizoaffective disorder
- •Presence of bipolar disorder or current psychosis
- •Presence of organic mental disorder or pervasive developmental delay
- •Presence of current eating disorder
- •Presence of current substance abuse or dependence
- •Presence of antisocial, borderline, or schizotypal personality disorder
- •Presence of imminent suicide or homicide risk
- •Presence of any other axis I or II disorders that necessitate priority treatment not provided by the study protocol
- •Women with any medical conditions that would preclude participation, including high-risk pregnancy
结局指标
主要结局
MBCT-PD Adherence Scale (MBCT-PD-AS)
时间窗: Up to 8 weeks
Treatment fidelity will be assessed to provide checks on the adequacy of treatment implementation, using the MBCT-PD Adherence Scale.
Engagement (class attendance)
时间窗: Up to 8 weeks
Engagement is operationalized in-part as class attendance, with completion is defined as attendance at a minimum of four classes, and daily home practice recorded daily as the number of times of practice and type of practice, which are classified as either formal or informal practice.
Client Satisfaction (CSQ-8)
时间窗: Up to 8 weeks
Participant satisfaction will be evaluated by the CSQ-8, which is designed to yield a homogeneous estimate of general satisfaction with services. An exit interview also will be completed at 6-months postpartum.
Change in Depressive Relapse Status: Longitudinal Interval Follow-up Evaluation (LIFE)
时间窗: Up to 6 months postpartum
Rate of depressive relapse and time to relapse will be assessed using the LIFE, which provides a retrospective assessment of relapse or recurrence based on a semi-structured interview according to DSM-IV-TR diagnostic criteria.
Change in Edinburgh Postpartum Depression Scale (EPDS)
时间窗: Up to 6 months postpartum
Change in the severity of depressive symptoms will be evaluated by the Edinburgh Postpartum Depression Scale (EPDS), which is the most widely used self-report measure of antenatal and postpartum depression.
次要结局
未报告次要终点
研究者
Sona Dimidjian
Professor and Director
University of Colorado, Boulder