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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
Results First Posted : August 28, 2019
Last Update Posted : August 28, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

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.

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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 111 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana

Arm Intervention/treatment
Experimental: CBT-I
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




Primary Outcome Measures :
  1. 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.

  2. 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

  3. 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

  4. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Locations
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United States, California
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, United States, 94304-1290
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Kimberly A Babson, PhD MA BS VA Palo Alto Health Care System, Palo Alto, CA
  Study Documents (Full-Text)

Documents provided by VA Office of Research and Development:
Statistical Analysis Plan  [PDF] February 24, 2014
Study Protocol  [PDF] June 29, 2015

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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02102230    
Other Study ID Numbers: CLIN-016-13F
First Posted: April 2, 2014    Key Record Dates
Results First Posted: August 28, 2019
Last Update Posted: August 28, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by VA Office of Research and Development:
Sleep Initiation and Maintenance Disorders
marijuana abuse
Veterans
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases