Dormir Mejor Study: Randomized Controlled Trial of a Culturally Adapted Digital Program of Cognitive-Behavioral Therapy for Insomnia for Spanish Speaking Latina/o Primary Care Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Change in Mean Insomnia Severity Index Score (ISI)
研究概览
简要总结
The primary objective of the proposed study is to examine the effectiveness of a culturally adapted digital program of cognitive behavioral therapy for insomnia (CBT-I) compared to minimally enhanced usual care (mEUC) on primary outcomes: reduction in insomnia symptoms at 9 weeks and 6 months post-intervention, using a standard scale among Spanish-Speaking Latina/o adults with chronic insomnia.
详细描述
Chronic insomnia is associated with significant public health burden and most adults seek care for insomnia in the primary care setting. While Latina/os are at greater risk for insomnia than non-Hispanic Whites, access to the recommended first-line of treatment, cognitive behavioral therapy for insomnia, is limited especially for Spanish-speakers. Recent advances in health information technology such as self-guided digital health treatments represent an innovative and scalable means to address the supply and demand imbalance that perpetuate mental health care disparities, however its implementation in underserved communities remains elusive. The purpose of this study is to compare the effectiveness of a culturally adapted digital version of Cognitive Behavioral Therapy for Insomnia with minimally enhanced usual care on reduction of insomnia symptoms among Spanish-speaking Latina/os adults with chronic insomnia. The study will also examine barriers and facilitators to implementation, and examine cost-effectiveness of the intervention.
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)
盲法说明
Outcome assessors will be blinded to treatment condition
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Insomnia Severity Index Score for moderate insomnia symptoms (score>10 on ISS)
- •Spanish-speaking or bilingual (English and Spanish) and self-identify as Hispanic or Latina/o
- •Report experience of sleep disturbances for at least 3x/week and for at least 3 months
排除标准
- •Pregnancy
- •Excessive sleepiness (score>=16 on ESS)
- •Caregivers of infants (< 3 months) and/or of adults who require care at night
- •Participants who are deemed unable to complete the study protocol due to dementia, severe cognitive impairment, severe medical or mental illness, or active substance use disorder
- •Untreated moderate to severe obstructive sleep apnea or self-reported narcolepsy
- •Unstable depression or insomnia medication regimen
- •Patients who have full-time transportation/moving occupations
- •Participation in another treatment/intervention study within the time period of initial baseline until the 6-month follow-up assessments
- •Participation in regular night shift work, more than 1x/week, or non-standard sleep patterns
结局指标
主要结局
Change in Mean Insomnia Severity Index Score (ISI)
时间窗: Baseline to 6 months post intervention
ISI is a 7-item self-report scale measuring insomnia symptom severity in the last 2 weeks; summed score ranges 0-28, increasing score associated with increasing severity.
次要结局
- Change in Mean Quality of Life Score (Short-Form 12 [SF-12], MCS, Mental Component Score)(Baseline to post-intervention (9 weeks))
- Change in Mean Daytime Sleepiness- Epworth Sleepiness Scale (ESS)(Baseline to post-intervention (9 weeks))
- Change in Mean Satisfaction With Care Patient Assessment of Chronic Illness Care (PACIC)(Baseline to post-intervention (9 weeks))
- Change in Mean Daytime Sleepiness- Epworth Sleepiness Scale (ESS)(Baseline to post-intervention (9 weeks))
- Change in Mean Satisfaction With Care Patient Assessment of Chronic Illness Care (PACIC)(Baseline to post-intervention (9 weeks))
研究者
Carmela Alcantara
Associate Professor
Columbia University