CBT-I for Cannabis Use (CBT-I-CU)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02102230|
Recruitment Status : Terminated (Principle Investigator as left government service)
First Posted : April 2, 2014
Last Update Posted : July 19, 2017
|Condition or disease||Intervention/treatment||Phase|
|Marijuana Abuse Sleep Initiation and Maintenance Disorders||Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I) Behavioral: quasi-desensitization Behavioral: Cognitive Behavioral Therapy for Insomnia plus Mobile App||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||113 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||The Impact of CBT-I on Cannabis Cessation Outcomes|
|Actual Study Start Date :||November 3, 2014|
|Actual Primary Completion Date :||March 24, 2017|
|Actual Study Completion Date :||March 24, 2017|
Group CBT-I with Adjunct Mobile Application
Behavioral: Cognitive Behavioral Therapy for Insomnia plus Mobile App
Group-based behavioral intervention for insomnia with adjunct information provided by mobile application
Other Name: CBT-I-MA
Active Comparator: CBT-I
Group CBT-I only
Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I)
Behavioral intervention for insomnia
Other Name: CBT-I
Placebo Comparator: PC
behavioral placebo control
Other Name: placebo intervention
- change in cannabis use frequency over time [ Time Frame: baseline, 6-weeks post-baseline, 2-weeks post-quit, 4 weeks post-quit, 6-months post-quit ]Measures will include the Timeline Followback for cannabis
- point prevalence abstinence over the three post-quit attempt assessments [ Time Frame: 2-weeks post-quit, 4 weeks post-quit, 6-months post-quit ]point prevalence abstinence will be assessed using the Timeline Follow-back measure for cannabis
- Change in Self-reported Sleep Quality over time [ Time Frame: 2-weeks post-quit, 4-weeks post-quit, 6-months post-quit ]Self-reported sleep quality will be measured using the Consensus Sleep Diary
- Change in Objective Sleep Quality over time [ Time Frame: 2-weeks post-quit, 4-weeks post-quit, 6-months post-quit ]Objective sleep quality will be measured via actigraphy
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02102230
|United States, California|
|VA Palo Alto Health Care System, Palo Alto, CA|
|Palo Alto, California, United States, 94304-1290|
|Principal Investigator:||Kimberly A Babson, PhD MA BS||VA Palo Alto Health Care System, Palo Alto, CA|