CBT-I for Cannabis Use

Not Applicable

Terminated

Conditions: Sleep Initiation and Maintenance Disorders
Marijuana Abuse

Interventions: Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I)
Behavioral: Desensitization Treatment for Insomnia
Behavioral: Cognitive Behavioral Therapy for Insomnia Plus Mobile App (CBT-I-MA)

Registration Number: NCT02102230

Lead Sponsor: VA Office of Research and Development

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 111

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CBT-I	Cognitive Behavioral Therapy for Insomnia (CBT-I)	Group Cognitive-Behavioral Therapy for Insomnia (CBT-I)
PC	Desensitization Treatment for Insomnia	Desensitization Treatment for Insomnia (DTI)
CBT-I-MA	Cognitive Behavioral Therapy for Insomnia Plus Mobile App (CBT-I-MA)	Group Cognitive-Behavioral Therapy for Insomnia Plus Mobile App (CBT-I-MA)

Primary Outcome Measures

Name	Time	Method
Point Prevalence Abstinence Over the Three Post-quit Attempt Assessments	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	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	2-weeks post-quit, 4-weeks post-quit, 6-months post-quit	Objective sleep quality will be measured via actigraphy
Change in Cannabis Use Frequency Over Time	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.