Study Stopped
Principle Investigator as left government service
CBT-I for Cannabis Use
CBT-I-CU
The Impact of CBT-I on Cannabis Cessation Outcomes
1 other identifier
interventional
111
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2014
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 25, 2014
CompletedFirst Posted
Study publicly available on registry
April 2, 2014
CompletedStudy Start
First participant enrolled
November 3, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 24, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 24, 2017
CompletedResults Posted
Study results publicly available
August 28, 2019
CompletedAugust 28, 2019
July 1, 2019
2.4 years
March 25, 2014
March 19, 2019
July 19, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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.
baseline, 6-weeks post-baseline, 2-weeks post-quit, 4 weeks post-quit, 6-months post-quit
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
2-weeks post-quit, 4 weeks post-quit, 6-months post-quit
Change in Self-reported Sleep Quality Over Time
Self-reported sleep quality will be measured using the Consensus Sleep Diary
2-weeks post-quit, 4-weeks post-quit, 6-months post-quit
Change in Objective Sleep Quality Over Time
Objective sleep quality will be measured via actigraphy
2-weeks post-quit, 4-weeks post-quit, 6-months post-quit
Study Arms (3)
CBT-I
EXPERIMENTALGroup Cognitive-Behavioral Therapy for Insomnia (CBT-I)
CBT-I-MA
ACTIVE COMPARATORGroup Cognitive-Behavioral Therapy for Insomnia Plus Mobile App (CBT-I-MA)
PC
PLACEBO COMPARATORDesensitization Treatment for Insomnia (DTI)
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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;
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, 94304-1290, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Kimberly Babson, PhD
- Organization
- VA Palo Alto Health Care System
Study Officials
- PRINCIPAL INVESTIGATOR
Kimberly A Babson, PhD MA BS
VA Palo Alto Health Care System, Palo Alto, CA
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 25, 2014
First Posted
April 2, 2014
Study Start
November 3, 2014
Primary Completion
March 24, 2017
Study Completion
March 24, 2017
Last Updated
August 28, 2019
Results First Posted
August 28, 2019
Record last verified: 2019-07
Data Sharing
- IPD Sharing
- Will not share