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Principle Investigator as left government service
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CBT-I | Experimental | Group Cognitive-Behavioral Therapy for Insomnia (CBT-I) |
|
| CBT-I-MA | Active Comparator | Group Cognitive-Behavioral Therapy for Insomnia Plus Mobile App (CBT-I-MA) |
|
| PC | Placebo Comparator | Desensitization Treatment for Insomnia (DTI) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Behavioral Therapy for Insomnia (CBT-I) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
To be included in the current study individuals must
Exclusion Criteria:
Individuals will be excluded based on evidence of the following:
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| Name | Affiliation | Role |
|---|---|---|
| Kimberly A Babson, PhD MA BS | VA Palo Alto Health Care System, Palo Alto, CA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Palo Alto Health Care System, Palo Alto, CA | Palo Alto | California | 94304-1290 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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, 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 easily accessible to users. The app also provides plots of bed times, wake times, and sleep efficiency over time. |
| FG002 | Placebo Control (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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Veteran Cannabis Users | Posted | Mean | Standard Deviation | mean uses per period | baseline, 6-weeks post-baseline, 2-weeks post-quit, 4 weeks post-quit, 6-months post-quit |
|
Duration of study participation - 6 weeks of tx + 6 months safety f/u
No difference
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kimberly Babson, PhD | VA Palo Alto Health Care System | 831-325-1540 | kimberly.babson@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 24, 2014 | Jul 18, 2019 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Jun 29, 2015 | Jul 19, 2019 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D002189 | Marijuana Abuse |
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D020919 | Sleep Disorders, Intrinsic |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D003888 | Desensitization, Immunologic |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D007165 | Immunosuppression Therapy |
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|
|
| Cognitive Behavioral Therapy for Insomnia Plus Mobile App (CBT-I-MA) | Behavioral | 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 | Behavioral | 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. |
|
|
| BG001 | 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. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Age was not obtained from one subject. | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| marijuana use episodes per week | Mean | Standard Deviation | uses/week |
|
| OG001 | 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. |
| OG002 | 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. |
|
|
| 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 | 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. | Posted | Count of Participants | Participants | 2-weeks post-quit, 4 weeks post-quit, 6-months post-quit |
|
|
|
| Primary | Change in Self-reported Sleep Quality Over Time | Self-reported sleep quality will be measured using the Consensus Sleep Diary | Posted | Count of Participants | Participants | 2-weeks post-quit, 4-weeks post-quit, 6-months post-quit |
|
|
|
| Primary | Change in Objective Sleep Quality Over Time | Objective sleep quality will be measured via actigraphy | Posted | Count of Participants | Participants | 2-weeks post-quit, 4-weeks post-quit, 6-months post-quit |
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | 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. | 0 | 11 | 0 | 11 | 0 | 11 |
| EG002 | 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. | 0 | 24 | 0 | 24 | 0 | 24 |
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| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D007167 | Immunotherapy |
| D056747 | Immunomodulation |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D007158 | Immunologic Techniques |
| D008919 | Investigative Techniques |
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| number abstinent at 4 weeks post tx |
|
|
| number abstinent at 6 months |
|
|