CBT-I for Cannabis Use (CBT-I-CU)
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|ClinicalTrials.gov Identifier: NCT02102230|
Recruitment Status : Terminated (Principle Investigator as left government service)
First Posted : April 2, 2014
Results First Posted : August 28, 2019
Last Update Posted : August 28, 2019
|Condition or disease||Intervention/treatment||Phase|
|Marijuana Abuse Sleep Initiation and Maintenance Disorders||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||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 :||111 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 Cognitive-Behavioral Therapy for Insomnia (CBT-I)
Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I)
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.
Other Name: CBT-I
Active Comparator: CBT-I-MA
Group Cognitive-Behavioral Therapy for Insomnia Plus Mobile App (CBT-I-MA)
Behavioral: Cognitive Behavioral Therapy for Insomnia Plus Mobile App (CBT-I-MA)
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.
Other Name: CBT-I-MA
Placebo Comparator: PC
Desensitization Treatment for Insomnia (DTI)
Behavioral: Desensitization Treatment for Insomnia
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.
Other Name: DTI
- 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. 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.
- 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 count of number abstinent
- 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|