An interventional study of Cognitive Behavioral Therapy for insomnia (CBTi-CB-TM) and Sleep Hygiene Education (SHE-TM) in Insomnia, sponsored by University of Michigan. Recruiting at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2026-05-22.
Sponsored by University of Michigan · Not applicable, Interventional, and Health services research
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.
1,856 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 594 are open to participants now.
This study's planned enrollment of 200 is above the median of 73 across 1,631 interventional studies indexed under Sleep Initiation and Maintenance Disorders.
Browse Sleep Initiation and Maintenance Disorders studies →University of Michigan is the lead sponsor of 1,475 studies on the registry; 196 are open to participants now.
Of its 162 completed or terminated interventional studies of FDA-regulated products, 128 (79%) have results posted.
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EXCLUSION CRITERIA
Delivered via telemedicine
Behavioral: Cognitive Behavioral Therapy for insomnia (CBTi-CB-TM)
Delivered via telemedicine
Behavioral: Sleep Hygiene Education (SHE-TM)
Participants randomized to CBTi-CB-TM will participate in 6 individual telemedicine sessions delivered by a trained therapist to learn cognitive and behavioral strategies for insomnia.
Participants randomized to SHE-TM will participate in 6 individual telemedicine sessions delivered by a trained therapist to learn sleep hygiene and educational strategies for insomnia.
Frequency of cannabis use as measured by the Timeline Followback (TLFB)
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.
Time frame: Up to 6 months after intervention, approximately 32 weeks
Insomnia Severity Index (ISI) total score measured by the Insomnia Severity Index (ISI)
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.
Time frame: Up to 6 months after intervention, approximately 32 weeks
Mental Composite Score (MCS-12) as assessed by the 12-item Short-Form Health Survey (SF-12)
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
Time frame: Up to 6 months after intervention, approximately 32 weeks
EEG Delta Activity
The outcome of interest is change in the rate of dissipation of Non-Rapid Eye Movement (NREM) sleep Slow Wave Activity (SWA) over the course of the night (measured with the best-fit slope based on exponential regressions), but we will additionally evaluate change in SWA power in the first NREM period and averaged across the night
Time frame: Pre- and Post-Intervention
Plan to share: Yes — De-identified participant data will be uploaded biannually into the NIMH National Data Archive. This archive is accessible only by other researchers who are members and agree to data access protocols. All participant identifiers are stripped and data are uploaded using a Global Unique Identifier. Data to be shared include responses to self-report measures and polysomnography. In accordance with ClinicalTrials.gov guidelines, results will be shared here no later than one year after primary study completion.
Supporting information: Study protocol, Icf
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University of Michigan