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 (Roffman & Stephens, 2006), 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; Moore et al., 2003). 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 (Babson et al., 2012). In fact, 48%-77% of individuals making a cannabis cessation attempt report lapsing/relapsing specifically to manage poor sleep (Copersino et al., 2000; Levin et al., 2010). Therefore, when individuals with poor sleep attempt to quit using cannabis, not only is their coping mechanism removed, but they are also likely to experience withdrawal-related sleep difficulties, increasing risk for lapse/relapse. 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 CBT-I outcomes, however, such an approach has yet to be evaluated. The proposed CSR&D CDA-2 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 adjunctive sleep mobile app (CBT-I-MA), on both cannabis cessation and sleep outcomes among Veterans with CUD. We will test the following specific aims:
Aim 1 : Veterans receiving CBT-I-MA or CBT-I (compared to a placebo): (1.1) will experience greater reductions in cannabis use frequency over the 2-weeks, 4-weeks, and 6-months post- cessation; (1.2) and have greater point prevalence abstinence (PPA) over time.
Aim 2 : Those receiving CBT-I- MA or CBT-I (versus placebo) will experience (2.1) improved sleep quality; with (2.2) group-based differences in cannabis outcomes over time explained by sleep quality over time. In addition, those who receive CBT-I-MA will evidence better cannabis cessation and sleep outcomes compared to those who receive CBT-I alone. Exploratory analyses will evaluate mechanisms accounting for this difference. To test these aims, 168 Veterans with CUD and insomnia will be randomized into one of three groups: (1) CBT-I with adjunctive sleep mobile app (CBT-I-MA); (2) CBT-I only (CBT-I); or (3) Placebo-control (PC). Individuals will then complete assessments at 2-weeks, 4-weeks, and 6-months post-quit. Our primary outcomes will be evaluated over time and secondary analyses will examine effects at each time point. Findings from the proposed study will inform clinical practice and policy by investigating whether the inclusion of a behavioral sleep intervention, within the context of existing SUD treatment, will improve treatment outcomes. In addition, the incremental benefit of including an adjunctive mobile app will be evaluated, as well as mechanisms underlying this benefit. Findings will set the stage for an effectiveness study of CBT-I (supplemented by mobile app) to directly address the critical need of improving SUD outcomes.

Public Health Relevance

The proposed CDA-2 will provide Dr. Babson with the training and data to advance research and policy aimed at improving mental health care among Veterans. The proposed study will employ a novel, multi-method approach to investigate the efficacy of group-based CBT-I, and the incremental benefit provided by an adjunctive sleep mobile app, in improving cannabis treatment outcomes among 168 cannabis dependent Veterans. Information from this study can be directly applied to improve SUD treatment among Veterans by targeting sleep disturbances in order to reduce rates of lapse/relapse and improve outcomes. Improved outcomes from SUD treatment can help reduce recidivism, allowing for resources to be allocated to new incidences of SUDs, and reduce wait times to receive services. Finally, these data can be used to influence policy, with the ultimate goal of increasing the efficacy, and value of SUD treatment.

Agency
National Institute of Health (NIH)
Institute
Veterans Affairs (VA)
Type
Veterans Administration (IK2)
Project #
5IK2CX001023-02
Application #
8848681
Study Section
Clinical Trials (CLIN)
Project Start
2014-07-01
Project End
2019-06-30
Budget Start
2015-07-01
Budget End
2016-06-30
Support Year
2
Fiscal Year
2015
Total Cost
Indirect Cost
Name
Veterans Admin Palo Alto Health Care Sys
Department
Type
DUNS #
046017455
City
Palo Alto
State
CA
Country
United States
Zip Code
94304
Hasan, Nadeem S; Babson, Kimberly A; Banducci, Anne N et al. (2015) The prospective effects of perceived and laboratory indices of distress tolerance on cannabis use following a self-guided quit attempt. Psychol Addict Behav 29:933-40
Babson, Kimberly A; Ramo, Danielle E; Baldini, Lisa et al. (2015) Mobile App-Delivered Cognitive Behavioral Therapy for Insomnia: Feasibility and Initial Efficacy Among Veterans With Cannabis Use Disorders. JMIR Res Protoc 4:e87