Targeting Insomnia to Improve Outcomes in Adults With Problematic Cannabis Use
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Insomnia
- Sponsor
- University of Michigan
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Frequency of cannabis use as measured by the Timeline Followback (TLFB)
- Status
- Recruiting
- Last Updated
- 8 months ago
Overview
Brief Summary
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.
Investigators
J. Todd Arnedt
Professor of Psychiatry, Professor of Neurology
University of Michigan
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Frequency of cannabis use as measured by the Timeline Followback (TLFB)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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
Secondary Outcomes
- EEG Delta Activity(Pre- and Post-Intervention)