Randomized Controlled Trial of Mindfulness-based Stress Reduction Plus Prenatal Sleep Supplement Versus Usual Care: Acceptability, Feasibility, and Adherence
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Number of Participants With a Total Score Greater Than or Equal to 24 on the 8-item Client Satisfaction Questionnaire (CSQ-8) at 12 Weeks
研究概览
简要总结
The overarching goal is to utilize a randomized control design to examine acceptability, feasibility, and adherence of mindfulness-based stress reduction plus prenatal sleep supplement (MBSR+PS) compared to treatment as usual among pregnant people with poor sleep quality (n=50).
详细描述
Poor sleep quality is highly prevalent during pregnancy, with important implications for maternal and infant health and well-being. Despite this, there is limited research on interventions to improve prenatal sleep, and prior research did not target the specific factors contributing to poor sleep quality in this population. Specifically, pregnant people report that physical symptoms, including discomfort and pain, disturb their sleep. In non-pregnant populations, this pain-sleep relationship is bidirectional, and maladaptive psychological responses to pain further exacerbate poor sleep. Theory and empirical evidence indicate that mindfulness-based interventions may be effective for targeting these psychological responses. The overarching goal is to utilize a randomized control design to examine acceptability, feasibility, and adherence of mindfulness-based stress reduction plus prenatal sleep supplement (MBSR+PS) compared to treatment as usual among pregnant people with poor sleep quality (n=50). Participants will be recruited to complete study questionnaires at two timepoints during pregnancy. Participants randomized to MBSR+PS will receive usual care, will be asked to attend 8 weekly group MBSR sessions (in addition to the MBSR orientation session, 1:1 interview with the instructor, and daylong retreat) and 6-8 PS sessions individually or in small groups, and will complete daily sleep and home practice diaries. Participants randomized to treatment as usual will receive usual care.
The specific aims are:
- To determine acceptability of MBSR+PS.
- To determine feasibility of MBSR+PS.
- To determine adherence to MBSR+PS.
- To explore evidence of change in psychological mediators.
- To explore between-group differences in sleep.
- To explore group differences in other critical clinical outcomes (e.g. depressive symptoms, anxiety symptoms, stress).
There is strong conceptual basis to predict the potential benefit of this approach for pregnant people. Targeting psychological responses to poor sleep during pregnancy may have significant public health benefits.
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
- 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
- 否
入选标准
- •Pregnancy 12-28 weeks gestation at time of intervention start
- •18 years of age or older
- •Regular access to a web-enabled computer, phone or tablet
- •Ability to read and speak English, and to provide informed consent
- •Poor sleep quality (PSQI > 5)
排除标准
- •Self-reported sleep disorder (e.g. sleep apnea, narcolepsy, parasomnia, circadian rhythm disorder)
- •Shift-work or nighttime caregiving responsibilities
- •Psychological, medical, or other issues that necessitate priority treatment (e.g. active suicidality, probable depression (PHQ-9 ≥ 10), psychosis, on bed rest, multiple gestation)
- •Current regular mindfulness practice (>20 minutes/week)
结局指标
主要结局
Number of Participants With a Total Score Greater Than or Equal to 24 on the 8-item Client Satisfaction Questionnaire (CSQ-8) at 12 Weeks
时间窗: Post-intervention, an average of 12 weeks
The Client Satisfaction Questionnaire (CSQ-8) score ranges from 8 to 32, with high scores indicating greater satisfaction. The CSQ-8 score of participants randomized to MBSR+PS will be reported; participants randomized to TAU will not complete the CSQ-8 as the questions pertain to the MBSR+PS program.
次要结局
- Number of Participants Who Attend at Least One Session of MBSR and the PS Supplement From Baseline to 12 Weeks(Baseline to post-intervention, an average of 12 weeks)
- Duration of Home Practices From Baseline to 12 Weeks(Baseline to post-intervention, an average of 12 weeks)
- Change in Self Compassion Scale - Short Form (SCS-SF) From Baseline to 12 Weeks(Baseline and post-intervention, an average of 12 weeks)
- Change in Rumination-Reflection Questionnaire (RRQ) From Baseline to 12 Weeks(Baseline and post-intervention, an average of 12 weeks)
- Change in Pittsburgh Sleep Quality Index Score (PSQI) From Baseline to 12 Weeks(Baseline and post-intervention, an average of 12 weeks)
- Change in Patient Health Questionnaire-9 Score (PHQ-9) From Baseline to 12 Weeks(Baseline to post-intervention, an average of 12 weeks)
- Change in Insomnia Severity Index Score (ISI) From Baseline to 12 Weeks(Baseline and post-intervention, an average of 12 weeks)
- Change in Dysfunctional Beliefs About Sleep Score (DBAS) From Baseline to 12 Weeks(Baseline and post-intervention, an average of 12 weeks)
- Change in PROMIS 6-item Anxiety Score From Baseline to 12 Weeks(Baseline and post-intervention, an average of 12 weeks)
- Change in Perceived Stress Scale Score (PSS) From Baseline to 12 Weeks(Baseline and post-intervention, an average of 12 weeks)
- Completeness of Study Measures at Baseline and at 12 Weeks(Baseline and post-intervention, an average of 12 weeks)
- Number of Participants Completing Endpoint Measures at 12 Weeks(Post-intervention, an average of 12 weeks)
- Percentage of MBSR and PS Sessions Attended(Baseline to post-intervention, an average of 12 weeks)
- Frequency of Home Practices From Baseline to 12 Weeks(Baseline to post-intervention, an average of 12 weeks)
- Change in Five-Facet Mindfulness Questionnaire (FFMQ) Nonjudging and Nonreactivity Factors From Baseline to 12 Weeks(Baseline and post-intervention, an average of 12 weeks)
- Change in Measures for Coping With Sleep Disturbances Score From Baseline to 12 Weeks(Baseline and post-intervention, an average of 12 weeks)
- Change in Coping Strategies Questionnaire - Revised (CSQ-R) From Baseline to 12 Weeks(Baseline and post-intervention, an average of 12 weeks)
- Worry About Sleep Duration(Post-intervention, an average of 12 weeks)