Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
NA
111 participants
INTERVENTIONAL
2014-11-03
2017-03-24
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Targeting Insomnia to Improve Outcomes in Adults With Problematic Cannabis Use
NCT05814822
The Efficacy of CBT-I in Alcoholics & Its Effects on Remission & Relapse
NCT01987089
CBT-I on Alcohol Treatment Outcomes Among Veterans
NCT03806491
Reducing Cannabis Use for Sleep Among Adults Using Medical Cannabis
NCT03964974
Efficacy of a Computerized Cognitive Behavioral Treatment for Insomnia: Increasing Access to Insomnia Treatment to Decrease Suicide Risk
NCT03366870
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
CBT-I
Group Cognitive-Behavioral Therapy for Insomnia (CBT-I)
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.
CBT-I-MA
Group Cognitive-Behavioral Therapy for Insomnia Plus Mobile App (CBT-I-MA)
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.
PC
Desensitization Treatment for Insomnia (DTI)
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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.
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 Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
VA Office of Research and Development
FED
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Kimberly A Babson, PhD MA BS
Role: PRINCIPAL_INVESTIGATOR
VA Palo Alto Health Care System, Palo Alto, CA
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, United States
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CLIN-016-13F
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.