Mindfulness Based Therapy for Insomnia in Black Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Retention
研究概览
简要总结
The purpose of the study is to conduct an 8-week RCT to improve insomnia among black women with insomnia and evaluate its feasibility, acceptability, and efficacy of Mindfulness Based Therapy for Insomnia (MBTI)
详细描述
Study design is a randomized clinical trial (RCT) with attention control. Participants will be randomly assigned to participate in either Mindfulness Based Therapy for Insomnia (MBTI) or time and attention control. Participants in the experimental group will receive the MBTI that includes mindfulness meditation and behavioral strategies for sleep. Participants in the control group will receive healthy lifestyle education that includes healthy eating, physical activity and sleep hygiene practice to mitigate insomnia.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •self-identified Black women
- •25-45 years old
- •English speaking
- •meeting DSM-5/ICSD3 diagnostic criteria for insomnia disorders defined as difficulty initiating or maintaining sleep with at least one associated daytime impairment symptom (Insomnia severity index > 7)
排除标准
- •Psychosis or unstable/ significant depression, anxiety, or substance abuse under active care (more than 1 monthly mental healthcare visit or requiring more than 1 psychotropic medicine daily)
- •significant current practice of any form of meditation (>15min per day)
- •obstructive sleep apnea (OSA), restless legs syndrome (RLS), or circadian rhythm related condition (shift worker, pregnancy, use of medication that influence circadian rhythm, e.g., Parkinson's disease)
- •other medical conditions that confound salivary biomarkers outcomes (e.g., radiation of salivary glands, Cushing or Addison's disease)
- •active or terminal cancer
结局指标
主要结局
Retention
时间窗: 10 weeks
Retention will be measured in the study. The following information will be collected: percentage of participants completing baseline and follow-up assessments, reasons for dropouts
Enrollment
时间窗: 10 weeks
The refusal rate of enrollment will be used to measure enrollment to determine feasibility
Change in Fidelity
时间窗: Baseline and week 10
Fidelity: Self-report checklist by interventionists and observers. We will use the Treatment Fidelity Tool for Mindfulness Interventions.
Change in sleep onset latency
时间窗: Baseline and week 10
Sleep onset latency is the amount of time, in minutes, it takes a person to fall asleep. It begins at "light out' when the lights are turned off and the person attempts to fall asleep, and ends at sleep onset. A sleep latency of 10-20 minutes is considered normal.
Change in sleep efficiency and quality
时间窗: Baseline and week 10
Will be measured by a wrist sleep actigraphy and sleep diary. Sleep efficiency is defined by the ratio of total sleep time to time in bed. Normal sleep efficiency for a healthy adult is 90% or higher. Sleep quality will be collected by participant's self-report using a 0-10 numerical scale (higher score means better sleep quality)
Change in perceived stress score (PSS)
时间窗: Baseline and week 10
The PSS has 10 items. It measures feelings and stressful thoughts for the past month. PSS ranges from 0 to 40 with higher scores indicating higher perceived stress. Scores ranging from 0-13 would be considered low stress. Scores ranging from 14-26 would be considered moderate stress. Scores ranging from 27-40 would be considered high perceived stress.
Change in Insomnia severity score
时间窗: Baseline and week 10
The reliable and valid Insomnia severity Index (ISI) for clinical diagnosis for insomnia (ICSD) will be used to determine insomnia severity score. Clinical cut points for ISI are as follows: no insomnia (0-7), sub-threshold insomnia (8-14), moderate insomnia (15-21), and severe insomnia (22-28). Response to the intervention on the ISI will be defined as a meaningful change of 7 or more points from baseline, or remission as reduction to a score less than 8.
Change in wake after sleep onset
时间窗: Baseline and week 10
Wake after sleep onset (WASO) is the amount of wake time in minutes during the attempted sleeping period after sleep onset has been achieved.
Change in total sleep time
时间窗: Baseline and week 10
Total sleep time or duration is computed by asking participants what time they wake-up and what time they go to bed (range from 0 min-1440 min).
次要结局
- Change in Patient Health Questionnaire (PHQ-9)(Baseline and week 10)
- Change in The Epworth Sleepiness Scale(Baseline and week 10)
- Change in The Dysfunctional Beliefs and Attitudes about Sleep (DBAS)(Baseline and week 10)
- Change in Five Facet Mindfulness Questionnaire (FFMQ)(Baseline and week 10)
- Change in Cortisol(Baseline and week 10)
- Change in C-reactive protein [CRP](Baseline and week 10)
- Change in cytokines [IL-1β, IL-6, TNF- α])(Baseline and week 10)
- Change in The Sleep Hygiene Practice Scale (SHPS)(Baseline and week 10)
- Change in The Trait Anxiety Scale(Baseline and week 10)
- Change in Pittsburgh Sleep Quality Index (PSQI)(Baseline and week 10)