Targeting Insomnia to Improve Outcomes in Adults With Problematic Cannabis Use

Study Overview
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Brief Summary
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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.

Official Title
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Targeting Insomnia to Improve Outcomes in Adults With Problematic Cannabis Use

Conditions
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Insomnia

Intervention / Treatment
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* Behavioral: Cognitive Behavioral Therapy for insomnia (CBTi-CB-TM)
* Behavioral: Sleep Hygiene Education (SHE-TM)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Self-reported chronic insomnia Insomnia Severity Index (ISI) score indicative of at least mild insomnia Cannabis Use Disorder Identification Test-Revised (CUDIT-R) indicative of at least problematic cannabis use A positive urine drug screen (UDS) for cannabis Self-reported use of cannabis to manage insomnia 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 Exclusion Criteria: Individuals who do not understand English Individuals judged unable to provide informed consent (e.g., intoxication, mental incompetence) Diagnosis or high suspicion of a sleep disorder other than insomnia Diagnosis of psychotic disorder, bipolar disorder, or post-traumatic stress disorder 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.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive Behavioral Therapy for insomnia (CBTi-CB-TM)<br>Delivered via telemedicine | Behavioral: Cognitive Behavioral Therapy for insomnia (CBTi-CB-TM)<br>* 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.<br>|
| Active Comparator: Sleep Hygiene Education<br>Delivered via telemedicine | Behavioral: Sleep Hygiene Education (SHE-TM)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of cannabis use as measured by the Timeline Followback (TLFB) | The TLFB is an interviewer-administered calendar-guided instrument that is the gold standard tool for assessing daily substance use. | Up to 6 months after intervention, approximately 32 weeks | 
| Insomnia Severity Index (ISI) total score measured by the Insomnia Severity Index (ISI) | The ISI is a 7-item questionnaire used to examine insomnia severity over the past 2 weeks. Scores range from 0-28 with higher scores indicating greater insomnia symptom severity. | 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 MCS-12 is a composite score derived from the 12-item Short-Form Health Survey quality of life measure. Scores range from 0-100 with higher scores indicating better health. | Up to 6 months after intervention, approximately 32 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cannabis