Cognitive Behavioral Therapy for Insomnia: Face-to-Face Versus Telemedicine
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Change in Insomnia Severity Index (ISI)
研究概览
简要总结
The purpose of this study is to compare the effectiveness of Cognitive-Behavioral Therapy (CBT) for insomnia conducted face-to-face with a therapist versus CBT for insomnia conducted using Internet-based videoconference technology.
详细描述
The objective of this clinical trial is to compare the effectiveness of telemedicine Cognitive-Behavioral Therapy (CBT) for insomnia [via the American Academy of Sleep Medicine Sleep Telemedicine (AASM Sleep TM) platform] to gold standard face-to-face CBT for insomnia. The central hypothesis is that CBT for insomnia delivered by AASM SleepTM will be comparable to face-to-face CBT for insomnia for clinical outcomes and patient satisfaction, but AASM SleepTM will be a more cost effective treatment modality (primarily through reduced costs associated with facility use and patient time). The rationale for the proposed project is rooted in the critical need to disseminate CBT for insomnia using the most effective and efficient modalities, with recognition that therapist involvement likely produces the most favorable 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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Current diagnosis of insomnia
排除标准
- •Suspicion of or inadequately treated sleep disorder other than insomnia
- •Presence of psychiatric disorders for which CBT for insomnia may be contraindicated
- •Unstable chronic medical condition directly related to insomnia
- •Routine overnight shift work
- •Previous failed adequate trial of CBT for insomnia
- •Unstable dose of sleep medications
- •Lack of access to reliable WiFi connection in the home
研究组 & 干预措施
Face to Face CBT-I (F2F)
Participants in the F2F arm will receive a standard 6-session course of Cognitive-Behavioral Therapy for Insomnia (CBT-I) delivered in-person, one-on-one with a qualified and experienced therapist.
干预措施: Face to Face CBT-I (F2F) (Behavioral)
Telemedicine CBT-I (TM)
Participants in the F2F arm will receive a standard 6-session course of Cognitive-Behavioral Therapy for Insomnia (CBT-I) delivered via the American Academy of Sleep Medicine (AASM) Sleep Telemedicine system. This telemedicine system provides an online videoconference platform in which a qualified and experienced therapist will deliver CBT-I to participants who will call in to the video therapy sessions with their provider from their homes using a webcam. All aspects of the treatment will remain identical to standard CBT-I delivered face-to-face, as described above, with the exception that the telemedicine technology will be used to deliver the treatment via video conference.
干预措施: Telemedicine CBT-I (TM) (Behavioral)
结局指标
主要结局
Change in Insomnia Severity Index (ISI)
时间窗: Baseline, post-treatment (about 6 weeks), follow-up (about 12-weeks post-treatment)
The ISI is a 7-item questionnaire assessing the nature, severity, and impact of sleep problems, with good psychometric properties and sensitivity to change with treatment 0-7 = No clinically significant insomnia 8-14 = Subthreshold insomnia 15-21 = Clinical insomnia (moderate severity) 22-28 = Clinical insomnia (severe)
次要结局
- Client Satisfaction Questionnaire (CSQ-8)(Post-treatment (about 6 weeks))
- Change in Therapy Evaluation Questionnaire (TEQ)(Baseline, post-treatment (about 6 weeks), follow-up (about 12-weeks post-treatment))
研究者
J. Todd Arnedt
Associate Professor
University of Michigan