Marijuana Abuse, Sleep Initiation and Maintenance Disorders
Conditions
Keywords
Sleep Initiation and Maintenance Disorders, marijuana abuse, Veterans
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.
Interventions
BEHAVIORALCognitive 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.
BEHAVIORALCognitive 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.
BEHAVIORALDesensitization 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.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 25 |
| 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, 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. | 11 |
| Placebo 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. | 24 |
| Total | 60 |
Baseline characteristics
| Characteristic | CBT-I | Total | Placebo | CBT-I-MA |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 25 Participants | 60 Participants | 24 Participants | 11 Participants |
| Age, Continuous | 46.08 years STANDARD_DEVIATION 17.49 | 48.34 years STANDARD_DEVIATION 15.83 | 52.46 years STANDARD_DEVIATION 14.79 | 44.27 years STANDARD_DEVIATION 13.24 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 6 Participants | 2 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 20 Participants | 49 Participants | 20 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 5 Participants | 2 Participants | 1 Participants |
| marijuana use episodes per week | 12.0051 uses/week STANDARD_DEVIATION 12.04773 | 10.3 uses/week STANDARD_DEVIATION 12 | 9.5079 uses/week STANDARD_DEVIATION 13.31989 | 8.0583 uses/week STANDARD_DEVIATION 7.59805 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 12 Participants | 6 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 9 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) White | 17 Participants | 37 Participants | 14 Participants | 6 Participants |
| Region of Enrollment United States | 25 Participants | 60 Participants | 24 Participants | 11 Participants |
| Sex: Female, Male Female | 1 Participants | 3 Participants | 1 Participants | 1 Participants |
| Sex: Female, Male Male | 24 Participants | 57 Participants | 23 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 11 | 0 / 24 |
| other Total, other adverse events | 0 / 25 | 0 / 11 | 0 / 24 |
| serious Total, serious adverse events | 0 / 25 | 0 / 11 | 0 / 24 |
Outcome results
Primary
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.
Time frame: baseline, 6-weeks post-baseline, 2-weeks post-quit, 4 weeks post-quit, 6-months post-quit
Population: Veteran Cannabis Users
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CBT-I | Change in Cannabis Use Frequency Over Time | 6-months post-quit | 14.1378 mean uses per period | Standard Deviation 22.69275 |
| CBT-I | Change in Cannabis Use Frequency Over Time | 2-weeks post-quit | 12.9176 mean uses per period | Standard Deviation 17.13794 |
| CBT-I | Change in Cannabis Use Frequency Over Time | baseline | 12.0051 mean uses per period | Standard Deviation 12.04773 |
| CBT-I | Change in Cannabis Use Frequency Over Time | 4 weeks post-quit | 13.6964 mean uses per period | Standard Deviation 19.53661 |
| CBT-I | Change in Cannabis Use Frequency Over Time | 6-weeks post-baseline | 11.5714 mean uses per period | Standard Deviation 13.11763 |
| CBT-I-MA | Change in Cannabis Use Frequency Over Time | baseline | 8.0583 mean uses per period | Standard Deviation 7.59805 |
| CBT-I-MA | Change in Cannabis Use Frequency Over Time | 6-weeks post-baseline | 12.6071 mean uses per period | Standard Deviation 7.58119 |
| CBT-I-MA | Change in Cannabis Use Frequency Over Time | 2-weeks post-quit | 10.0476 mean uses per period | Standard Deviation 6.30247 |
| CBT-I-MA | Change in Cannabis Use Frequency Over Time | 4 weeks post-quit | 11.3810 mean uses per period | Standard Deviation 7.42628 |
| CBT-I-MA | Change in Cannabis Use Frequency Over Time | 6-months post-quit | 17.0000 mean uses per period | Standard Deviation 4.24264 |
| Placebo | Change in Cannabis Use Frequency Over Time | 6-months post-quit | 8.7385 mean uses per period | Standard Deviation 9.77943 |
| Placebo | Change in Cannabis Use Frequency Over Time | 4 weeks post-quit | 4.9388 mean uses per period | Standard Deviation 4.71061 |
| Placebo | Change in Cannabis Use Frequency Over Time | 6-weeks post-baseline | 19.6339 mean uses per period | Standard Deviation 49.166 |
| Placebo | Change in Cannabis Use Frequency Over Time | 2-weeks post-quit | 7.5663 mean uses per period | Standard Deviation 11.02617 |
| Placebo | Change in Cannabis Use Frequency Over Time | baseline | 9.5079 mean uses per period | Standard Deviation 13.31989 |
Primary
Change in Objective Sleep Quality Over Time
Objective sleep quality will be measured via actigraphy
Time frame: 2-weeks post-quit, 4-weeks post-quit, 6-months post-quit
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CBT-I | Change in Objective Sleep Quality Over Time | NA Participants |
| CBT-I-MA | Change in Objective Sleep Quality Over Time | NA Participants |
| Placebo | Change in Objective Sleep Quality Over Time | NA Participants |
Primary
Change in Self-reported Sleep Quality Over Time
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CBT-I | Change in Self-reported Sleep Quality Over Time | NA Participants |
| CBT-I-MA | Change in Self-reported Sleep Quality Over Time | NA Participants |
| Placebo | Change in Self-reported Sleep Quality Over Time | NA Participants |
Primary
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
Time frame: 2-weeks post-quit, 4 weeks post-quit, 6-months post-quit
Population: All participants were considered analyzed by the intent to treat principle, but less than the overall number analyzed contributed data in all three arms. One Placebo participant missing at week 2 rejoined at week 4 and week 6.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CBT-I | Point Prevalence Abstinence Over the Three Post-quit Attempt Assessments | number abstinent at 4 weeks post tx | 0 Participants |
| CBT-I | Point Prevalence Abstinence Over the Three Post-quit Attempt Assessments | number abstinent at 2 weeks post tx | 0 Participants |
| CBT-I | Point Prevalence Abstinence Over the Three Post-quit Attempt Assessments | number abstinent at 6 months | 0 Participants |
| CBT-I-MA | Point Prevalence Abstinence Over the Three Post-quit Attempt Assessments | number abstinent at 4 weeks post tx | 0 Participants |
| CBT-I-MA | Point Prevalence Abstinence Over the Three Post-quit Attempt Assessments | number abstinent at 2 weeks post tx | 0 Participants |
| CBT-I-MA | Point Prevalence Abstinence Over the Three Post-quit Attempt Assessments | number abstinent at 6 months | 0 Participants |
| Placebo | Point Prevalence Abstinence Over the Three Post-quit Attempt Assessments | number abstinent at 2 weeks post tx | 0 Participants |
| Placebo | Point Prevalence Abstinence Over the Three Post-quit Attempt Assessments | number abstinent at 6 months | 0 Participants |
| Placebo | Point Prevalence Abstinence Over the Three Post-quit Attempt Assessments | number abstinent at 4 weeks post tx | 0 Participants |