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CBT-I for Cannabis Use (CBT-I-CU)

Primary Purpose

Marijuana Abuse, Sleep Initiation and Maintenance Disorders

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy for Insomnia (CBT-I)
Cognitive Behavioral Therapy for Insomnia Plus Mobile App (CBT-I-MA)
Desensitization Treatment for Insomnia
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Marijuana Abuse focused on measuring Sleep Initiation and Maintenance Disorders, marijuana abuse, Veterans

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • VA Palo Alto Health Care System, Palo Alto, CA

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

CBT-I

CBT-I-MA

PC

Arm Description

Group Cognitive-Behavioral Therapy for Insomnia (CBT-I)

Group Cognitive-Behavioral Therapy for Insomnia Plus Mobile App (CBT-I-MA)

Desensitization Treatment for Insomnia (DTI)

Outcomes

Primary Outcome Measures

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.
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
Change in Self-reported Sleep Quality Over Time
Self-reported sleep quality will be measured using the Consensus Sleep Diary
Change in Objective Sleep Quality Over Time
Objective sleep quality will be measured via actigraphy

Secondary Outcome Measures

Full Information

First Posted
March 25, 2014
Last Updated
July 19, 2019
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT02102230
Brief Title
CBT-I for Cannabis Use
Acronym
CBT-I-CU
Official Title
The Impact of CBT-I on Cannabis Cessation Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Terminated
Why Stopped
Principle Investigator as left government service
Study Start Date
November 3, 2014 (Actual)
Primary Completion Date
March 24, 2017 (Actual)
Study Completion Date
March 24, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Marijuana Abuse, Sleep Initiation and Maintenance Disorders
Keywords
Sleep Initiation and Maintenance Disorders, marijuana abuse, Veterans

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
111 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CBT-I
Arm Type
Experimental
Arm Description
Group Cognitive-Behavioral Therapy for Insomnia (CBT-I)
Arm Title
CBT-I-MA
Arm Type
Active Comparator
Arm Description
Group Cognitive-Behavioral Therapy for Insomnia Plus Mobile App (CBT-I-MA)
Arm Title
PC
Arm Type
Placebo Comparator
Arm Description
Desensitization Treatment for Insomnia (DTI)
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy for Insomnia (CBT-I)
Other Intervention Name(s)
CBT-I
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy for Insomnia Plus Mobile App (CBT-I-MA)
Other Intervention Name(s)
CBT-I-MA
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Desensitization Treatment for Insomnia
Other Intervention Name(s)
DTI
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Cannabis Use Frequency Over Time
Description
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.
Time Frame
baseline, 6-weeks post-baseline, 2-weeks post-quit, 4 weeks post-quit, 6-months post-quit
Title
Point Prevalence Abstinence Over the Three Post-quit Attempt Assessments
Description
point prevalence abstinence will be assessed using the Timeline Follow-back measure for cannabis count of number abstinent
Time Frame
2-weeks post-quit, 4 weeks post-quit, 6-months post-quit
Title
Change in Self-reported Sleep Quality Over Time
Description
Self-reported sleep quality will be measured using the Consensus Sleep Diary
Time Frame
2-weeks post-quit, 4-weeks post-quit, 6-months post-quit
Title
Change in Objective Sleep Quality Over Time
Description
Objective sleep quality will be measured via actigraphy
Time Frame
2-weeks post-quit, 4-weeks post-quit, 6-months post-quit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kimberly A Babson, PhD MA BS
Organizational Affiliation
VA Palo Alto Health Care System, Palo Alto, CA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Palo Alto Health Care System, Palo Alto, CA
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304-1290
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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CBT-I for Cannabis Use

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