Targeting Insomnia to Improve Outcomes in Adults With Problematic Cannabis Use
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Frequency of cannabis use as measured by the Timeline Followback (TLFB)
研究概览
简要总结
This study will compare the efficacy of telemedicine-delivered cognitive behavioral therapy for insomnia tailored for people using cannabis for sleep (CBTi-CB-TM) to telemedicine-delivered sleep hygiene education (SHE-TM) on sleep, cannabis use, and daytime functioning. We will also evaluate the effects of CBTi-CB-TM on fundamental sleep regulatory system - homeostatic sleep drive - and its association with clinical outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •21 years of age and older, the age needed to obtain full legal access to cannabis in Michigan
- •Self-reported chronic insomnia (nighttime symptoms of difficulty initiating and/or maintaining sleep and/or early morning awakenings on ≥3 nights for ≥3 months with daytime impairment), consistent with DSM-5 diagnosis of Insomnia Disorder
- •Insomnia Severity Index (ISI) score ≥11, indicative of at least "mild" insomnia
- •A positive urine drug screen (UDS) for cannabis33
- •Self-reported use of cannabis at least three times weekly for the past month
- •Stable residence (e.g., stable sleep arrangements), consistent access to Wi-Fi, and ability to travel to Ann Arbor for sleep laboratory assessments
排除标准
- •Individuals who do not understand English (read and spoken)
- •Individuals judged unable to provide informed consent (e.g., intoxication, mental incompetence)
- •Diagnosis or high suspicion of a sleep disorder other than insomnia
- •Lifetime diagnosis of psychotic disorder or bipolar disorder; current post-traumatic stress disorder that directly interferes with sleep
- •Terminal or progressive physical illness (e.g., cancer) or neurological degenerative disease (e.g., dementia)
- •Use of medications known to have initiated their insomnia (e.g., steroids)
- •Previous receipt of CBTi
- •Self-reported pregnancy
- •Self-reported regular work schedule of rotating or night (3rd) shift work
- •Other conditions and situations, medical or otherwise, that preclude meaningful and/or safe participation in CNT/SHE and study procedures
研究组 & 干预措施
Cognitive Behavioral Therapy for insomnia (CBTi-CB-TM)
Delivered via telemedicine
干预措施: Cognitive Behavioral Therapy for insomnia (CBTi-CB-TM) (Behavioral)
Sleep Hygiene Education
Delivered via telemedicine
干预措施: Sleep Hygiene Education (SHE-TM) (Behavioral)
结局指标
主要结局
Frequency of cannabis use as measured by the Timeline Followback (TLFB)
时间窗: Up to 6 months after intervention, approximately 32 weeks
Changes in frequency of cannabis use will be evaluated over the past 30 days using the Timeline Followback, widely considered the "gold standard" tool for assessing daily substance use. It will be used to measure the frequency of use of THC-containing cannabis products used across all modalities guided by pictorial aids. Participants are asked to specify motivations behind cannabis use, including recreation, medicinal use, sleep aid, or other reasons. We will collect data on alcohol and other substance use during the interview. The primary outcome is frequency of cannabis use per day across all modalities. Participants obtain cannabis from a variety of sources and thus dose assessments using retrospective recall would not be reliable. We therefore chose frequency as our primary outcome, which is also recommended by expert consensus.
Insomnia Severity Index (ISI) total score measured by the Insomnia Severity Index (ISI)
时间窗: Up to 6 months after intervention, approximately 32 weeks
Changes in insomnia severity from baseline to post-treatment is assessed with the 7-item Insomnia Severity Index (ISI), a self-administered assessment of global insomnia severity over the past 2 weeks that ranges in score from 0 to 28, with higher scores indicating more severe insomnia symptoms (0-7 no clinical insomnia, 8-14 mild insomnia severity, 15-22 moderate insomnia severity, 23-28 severe insomnia severity). The primary outcome is ISI total score.
Mental Composite Score (MCS-12) as assessed by the 12-item Short-Form Health Survey (SF-12)
时间窗: Up to 6 months after intervention, approximately 32 weeks
The 12-item Short-Form Health Survey (SF-12) is a short-form quality of life measure derived from the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36). The primary outcome is the Mental Component Summary Score (MCS-12), which ranges from 0-100, with higher scores indicating better health
Frequency of cannabis use as measured by the Timeline Followback (TLFB)
时间窗: Up to 6 months after intervention, approximately 32 weeks
Changes in frequency of cannabis use will be evaluated over the past 30 days using the Timeline Followback, widely considered the "gold standard" tool for assessing daily substance use. It will be used to measure the frequency of use of THC-containing cannabis products used across all modalities guided by pictorial aids. Participants are asked to specify motivations behind cannabis use, including recreation, medicinal use, sleep aid, or other reasons. We will collect data on alcohol and other substance use during the interview. The primary outcome is frequency of cannabis use per day across all modalities. Participants obtain cannabis from a variety of sources and thus dose assessments using retrospective recall would not be reliable. We therefore chose frequency as our primary outcome, which is also recommended by expert consensus.
Insomnia Severity Index (ISI) total score measured by the Insomnia Severity Index (ISI)
时间窗: Up to 6 months after intervention, approximately 32 weeks
Changes in insomnia severity from baseline to post-treatment is assessed with the 7-item Insomnia Severity Index (ISI), a self-administered assessment of global insomnia severity over the past 2 weeks that ranges in score from 0 to 28, with higher scores indicating more severe insomnia symptoms (0-7 no clinical insomnia, 8-14 mild insomnia severity, 15-22 moderate insomnia severity, 23-28 severe insomnia severity). The primary outcome is ISI total score.
Mental Composite Score (MCS-12) as assessed by the 12-item Short-Form Health Survey (SF-12)
时间窗: Up to 6 months after intervention, approximately 32 weeks
The 12-item Short-Form Health Survey (SF-12) is a short-form quality of life measure derived from the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36). The primary outcome is the Mental Component Summary Score (MCS-12), which ranges from 0-100, with higher scores indicating better health
次要结局
- EEG Delta Activity(Pre- and Post-Intervention)
研究者
J. Todd Arnedt
Professor of Psychiatry, Professor of Neurology
University of Michigan