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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

Tracking Information
First Submitted Date  ICMJE March 25, 2014
First Posted Date  ICMJE April 2, 2014
Results First Submitted Date  ICMJE March 19, 2019
Results First Posted Date  ICMJE August 28, 2019
Last Update Posted Date August 28, 2019
Actual Study Start Date  ICMJE November 3, 2014
Actual Primary Completion Date March 24, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 19, 2019)
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: March 28, 2014)
  • 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
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE CBT-I for Cannabis Use
Official Title  ICMJE The Impact of CBT-I on Cannabis Cessation Outcomes
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Marijuana Abuse
  • Sleep Initiation and Maintenance Disorders
Intervention  ICMJE
  • 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
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: CBT-I
    Group Cognitive-Behavioral Therapy for Insomnia (CBT-I)
    Intervention: Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I)
  • Active Comparator: CBT-I-MA
    Group Cognitive-Behavioral Therapy for Insomnia Plus Mobile App (CBT-I-MA)
    Intervention: Behavioral: Cognitive Behavioral Therapy for Insomnia Plus Mobile App (CBT-I-MA)
  • Placebo Comparator: PC
    Desensitization Treatment for Insomnia (DTI)
    Intervention: Behavioral: Desensitization Treatment for Insomnia
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: July 19, 2019)
111
Original Estimated Enrollment  ICMJE
 (submitted: March 28, 2014)
168
Actual Study Completion Date  ICMJE March 24, 2017
Actual Primary Completion Date March 24, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02102230
Other Study ID Numbers  ICMJE CLIN-016-13F
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party VA Office of Research and Development
Study Sponsor  ICMJE VA Office of Research and Development
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kimberly A Babson, PhD MA BS VA Palo Alto Health Care System, Palo Alto, CA
PRS Account VA Office of Research and Development
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP