CBT-I for Cannabis Use

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the efficacy of a group-based behavioral sleep intervention, and the incremental benefit provided by an adjunct sleep mobile app, on cannabis and sleep outcomes among cannabis dependent Veterans.

Detailed Description
-----------------
The Prevalence of cannabis use disorder (CUD) has been steadily increasing within the Veteran Health Administration (VHA), along with the related significant physical, cognitive, and psychological sequelae. Even in patients with a strong motivation to quit and the presence of empirically-supported interventions, Veterans who receive treatment for CUD have high rates of lapse (63% by 6-months post-treatment) and relapse (71% within 6-months post-treatment). Thus, identifying strategies to improve response to CUD treatment is in the interest of all VHA stakeholders. Disturbed sleep is common among individuals with CUD and has been shown to result in increased rates of lapse/relapse to cannabis. Providing a behavioral sleep intervention within the context of CUD treatment, and prior to a cessation attempt, has the potential to improve these cessation outcomes. Cognitive behavioral therapy for insomnia (CBT-I) is a well-established first-line treatment for insomnia. While CBT-I is being disseminated throughout VHA, it is rarely received by Veterans with substance use disorders (SUDs) and, among those that do receive it, it is almost always delivered following a cessation attempt. While CBT-I has been shown to be an effective treatment for improving sleep among individuals with insomnia and co-occurring conditions, including SUDs, there has yet to be an investigation of the impact of providing CBT-I prior to CUD treatment with the goal of improving cessation outcomes. In addition, the development of an adjunct behavioral intervention delivered via mobile app technology within VA holds great promise to bolster outcomes. The current study seeks to fill this gap by conducting a randomized prospective study designed to evaluate the efficacy of CBT-I, as well as the incremental benefit of including an adjunct sleep mobile app (CBT-I-MA), on both cannabis and sleep outcomes among Veterans with CUD.

Official Title
-----------------
The Impact of CBT-I on Cannabis Cessation Outcomes

Conditions
-----------------
Marijuana Abuse, Sleep Initiation and Maintenance Disorders

Intervention / Treatment
-----------------
* Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I)
* Behavioral: Cognitive Behavioral Therapy for Insomnia Plus Mobile App (CBT-I-MA)
* Behavioral: Desensitization Treatment for Insomnia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: To be included in the current study individuals must be a Veteran 18 years or older meet Diagnostic and Statistical Manual of Mental Disorders-5 diagnostic criteria for cannabis use disorder; meet Diagnostic and Statistical Manual of Mental Disorders diagnostic criteria for insomnia; Exclusion Criteria: Individuals will be excluded based on evidence of the following: inability to provide fully-informed written consent to participate; history of, or current, psychotic symptoms; current pregnancy; Sleep apnea (>5 on the STOP-Bang assessment); active suicidal/homicidal intent.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CBT-I<br>Group Cognitive-Behavioral Therapy for Insomnia (CBT-I) | Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I)<br>* This is a group-delivered version of the six-session Cognitive-Behavioral Treatment for Insomnia that has been disseminated throughout the VA. It incorporates psychoeducation, diary-based sleep assessment, estimation of sleep scheduling and efficiency, evaluation/mitigation of dysfunctional sleep-related beliefs/ behaviors, generation of sleep prescription (typically restriction), iterative review of sleep efficiency and prescription, and planning for maintenance of gains.<br>* Other names: CBT-I;|
| Active Comparator: CBT-I-MA<br>Group Cognitive-Behavioral Therapy for Insomnia Plus Mobile App (CBT-I-MA) | Behavioral: Cognitive Behavioral Therapy for Insomnia Plus Mobile App (CBT-I-MA)<br>* This is a mobile-app-augmented, group-delivered version of the six-session Cognitive-Behavioral Treatment for Insomnia that has been disseminated throughout the VA. It incorporates psychoeducation, diary-based sleep assessment, estimation of sleep scheduling and efficiency, evaluation/mitigation of dysfunctional sleep-related beliefs/ behaviors, generation of sleep prescription (typically restriction), iterative review of sleep efficiency and prescription, and planning for maintenance of gains. The mobile-app augmentation substitutes a smartphone-based sleep diary with time-stamping of records to mitigate the common postponement of diary recording and consequent loss of validity. The app also records the sleep prescription, making it, along with links to web-based psychoeducational materials, easily accessible to users. The app also provides plots of bed times, wake times, and sleep efficiency over time, with the goal of promoting adherence.<br>* Other names: CBT-I-MA;|
| Placebo Comparator: PC<br>Desensitization Treatment for Insomnia (DTI) | Behavioral: Desensitization Treatment for Insomnia<br>* This is a group-delivered version of the sham sleep improvement treatment developed by Edinger which purports to desensitize the patient to the various aspects of the sleep experience which are presented as distressing.<br>* Other names: DTI;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Cannabis Use Frequency Over Time | Measures will include the Timeline Followback for cannabis. All of these measures are standard 7-day point prevalence estimates. In other words, the baseline measure is the number of uses in the 7 days prior to the baseline assessment day. The 6-weeks post-baseline is the number of uses in the 7 days prior to the 6-weeks post-baseline day, and so on. | baseline, 6-weeks post-baseline, 2-weeks post-quit, 4 weeks post-quit, 6-months post-quit | 
| Point Prevalence Abstinence Over the Three Post-quit Attempt Assessments | point prevalence abstinence will be assessed using the Timeline Follow-back measure for cannabis count of number abstinent | 2-weeks post-quit, 4 weeks post-quit, 6-months post-quit | 
| Change in Self-reported Sleep Quality Over Time | Self-reported sleep quality will be measured using the Consensus Sleep Diary | 2-weeks post-quit, 4-weeks post-quit, 6-months post-quit | 
| Change in Objective Sleep Quality Over Time | Objective sleep quality will be measured via actigraphy | 2-weeks post-quit, 4-weeks post-quit, 6-months post-quit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sleep Initiation and Maintenance Disorders, marijuana abuse, Veterans