An Internet-Delivered Mind-Body Program for Reducing Prenatal Maternal Stress
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 2
- 主要终点
- Change in perceived stress as indexed by Perceived Stress Scale (PSS) score
研究概览
简要总结
The present trial will evaluate the feasibility, acceptability and preliminary efficacy of 2 different internet-delivered programs for prenatal maternal stress. The Stress Managment and Resiliency Training Program (SMART-Mom program), an 8-session Cognitive Behavior Therapy (CBT) based mind body program and the Mama Support Program, an 8-session social support group program. Sixty pregnant women (<20 weeks Estimated Gestational Age) will be screened and either enrolled in the online SMART Mom Program or the Mama Support Program. Outcomes, including maternal perceived stress, depression, and anxiety will be assessed at post-treatment, three, and six months post program completion. Potential impact on infant health outcomes will be assessed via post-delivery electronic medical record review.
详细描述
Aim 1: The investigators will conduct a randomized clinical trial (RCT; n=60) to assess the feasibility, acceptability and preliminary efficacy of the Stress Management and Resillency Training program (SMART Pregnancy) delivered online versus a time and attention matched prenatal support group (Mama Support). It is expected that SMART-pregnancy participants will demonstrate high levels of treatment engagement and adherence. It is predicted that participants in the SMART-Pregnancy condition will demonstrate improvements in emotional distress and stress regulation (as indexed by hair cortisol concentrations) at post-treatment and 3 month follow-up. Aim 2: The investigators will conduct a postnatal chart review to explore secondary treatment benefits including pre-and postnatal maternal health and birth outcomes.
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
- Double (Participant, Outcomes Assessor)
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
- •<21 weeks pregnant with medically confirmed viability
- •Speak, read and write in English fluently,
- •Endorse elevated levels of prenatal maternal stress (PNMS; i.e., New Prenatal Distress Questionnaire Score > 19).
排除标准
- •Current enrollment in individual or group psychotherapy
- •Current un-managed serious mental illness including bipolar disorder and psychosis
- •History of previous suicide attempt
- •Inappropriate for participation in group therapy format as determined by study director
研究组 & 干预措施
Treatment as usual
Participants (n = 30) will be randomized to receive treatment as usual, including referrals to community based support groups and individual mental health providers.
干预措施: Mama Support (Behavioral)
Intervention
Participants (n = 30) will be randomized to receive the SMART Pregnancy stress management program via an online portal.
干预措施: SMART Mom (Behavioral)
结局指标
主要结局
Change in perceived stress as indexed by Perceived Stress Scale (PSS) score
时间窗: baseline, 8 weeks post enrollment, 20 weeks post enrollment
Gold standard measure of subjective stress experiences. Total scores range from 0 to 40; higher scores indicate greater stress.
Change in prenatal maternal distress as indexed by Prenatal Distress Questionnaire (NuPDQ) score
时间窗: baseline, 8 weeks post enrollment
Measure of prenatal maternal distress. Total scores range form 0-35; higher scores indicate greater pregnancy-related distress.
Change in Perceived Stress as Indexed by Perceived Stress Scale (PSS-10) Score
时间窗: T1 (treatment session 1/enrollment date, occurred within <2 weeks of baseline T0), T2 mid-treatment (4 weeks post enrollment), T3 post treatment (8 weeks post enrollment), T4 delayed follow up (20 weeks post enrollment).
The Perceived Stress Scale (PSS-10) is the gold standard measure of subjective stress experiences. Total scores range from 0 to 40; higher scores indicate greater stress or a worse outcome.
Change in Prenatal Maternal Distress as Indexed by the New Prenatal Distress Questionnaire (NuPDQ) Score
时间窗: T0 (baseline), T2 mid-treatment (4 weeks post enrollment). Not assessed at T1 (Enrollment, <2 weeks post T0).
The New Prenatal Distress Questionnaire (NuPDQ) is a measure of prenatal maternal psychological distress. Total scores range form 0-35; higher scores indicate greater pregnancy-related distress.
次要结局
- Patient-Reported Outcomes Measurement Information System (PROMIS) V.1 Emotional Distress-Depression(baseline, 8 weeks post enrollment, 20 weeks post enrollment)
- Cognitive and Affective Mindfulness Scale-Revised (CAMS-R)(baseline, 8 weeks post enrollment, 20 weeks post enrollment)
- Patient-Reported Outcomes Measurement Information System (PROMIS) V.1 Emotional Distress-Anxiety(baseline, 8 weeks post enrollment, 20 weeks post enrollment)
- Measure of Current Status-Form A (MOCS-A)(baseline, 8 weeks post enrollment, 20 weeks post enrollment)
- Patient Health Questionnaire. PHQ-9.(Baseline (T0), T2 mid-treatment (4 weeks post enrollment), T3 post treatment (8 weeks post enrollment), T4 delayed follow up (20 weeks post enrollment). Not assessed at T1 (Enrollment, <2 weeks post T0).)
- Generalized Anxiety Disorder -7 Item (GAD-7).(Baseline (T0), T2 mid-treatment (4 weeks post enrollment), T3 post treatment (8 weeks post enrollment), T4 delayed follow up (20 weeks post enrollment). Not assessed at T1 (Enrollment, <2 weeks post T0).)
- Cognitive and Affective Mindfulness Scale-Revised (CAMS-R)(Baseline (T0), T2 mid-treatment (4 weeks post enrollment), T3 post treatment (8 weeks post enrollment), T4 delayed follow up (20 weeks post enrollment). Not assessed at T1 (Enrollment, <2 weeks post T0).)
- Measure of Current Status-Form A (MOCS-A)(Baseline (T0), T2 mid-treatment (4 weeks post enrollment), T3 post treatment (8 weeks post enrollment), T4 delayed follow up (20 weeks post enrollment). Not assessed at T1 (Enrollment, <2 weeks post T0).)
研究者
Brittain Lynn Mahaffey
Assistant Professor
Stony Brook University