Randomized Controlled Study of the Effectiveness of Stepped-Care Sleep Therapy In General Practice
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 388
- 试验地点
- 2
- 主要终点
- Insomnia Severity Index (ISI)
研究概览
简要总结
This project aims to compare the effectiveness and implementation potential of two primary care friendly approaches to delivering an effective non-pharmacological intervention - cognitive behavioral therapy - for insomnia to middle aged and older adults.
详细描述
All participants will receive cognitive behavioral therapy for insomnia, either through an online program or through visit with a therapist specializing in behavioral sleep medicine, and is some cases both. Participants will be randomized with equal probability to an ONLINE ONLY treatment arm or to a STEPPED CARE arm, whereby they will be assigned to on line or therapist-led treatment, based on their clinical presentation; but those assigned to this arm who start treatment with an online program and do not have sufficient response after 2 months will be switched over to a therapist-led treatment.
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 (Investigator, Outcomes Assessor)
盲法说明
Participants are asked to refrain from mentioning any information about the treatment they receive when interacting with the investigator or outcomes assessors
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •insomnia disorder
排除标准
- •Unable to be consented in English without an interpreter
- •In poor physical or mental that limits capacity to participate in study treatment (e.g., Mini-Mental State Examination score < 25)
- •Unable to use the internet
- •Study physician determines participation is not medically advised for any reason
结局指标
主要结局
Insomnia Severity Index (ISI)
时间窗: at baseline and at months 2, 4, 6, 9, & 12
The ISI is an empirically validated 7-item questionnaire, with each item rated on a 0 to 4 scale. The score is the sum of the 7 items. scores range between 0 and 28 (higher score corresponds with greater insomnia severity), with 10 as a cutoff score for identifying individuals in the community who are likely to meet criteria for insomnia disorder and 8 as a cutoff for defining remission.
Use of Prescription Sleep Medication
时间窗: at baseline and at months 2, 4, 6, 9, & 12
The average number of minimal effective doses of prescription sleep medications taken; A greater number means that the person was taking number of minimal effective doses of prescription sleep medications, with a value of 0 meaning that the person is not taking any prescription sleep medication.
次要结局
- Patient-Reported Outcomes Measurement Information System (PROMIS) - Sleep Related Impairment Questionnaire(at baseline and at months 2, 4, 6, 9, & 12)
- PHQ-4 (The 4 Item Patient Health Questionnaire For Anxiety and Depression)(at baseline and at months 2, 4, 6, 9, & 12)
研究者
Rachel Manber
Professor
Stanford University