CBT-I-CU: CBT-I for Cannabis Use
Sponsor
VA Office of Research and Development (U.S. Fed)
Overall Status
Terminated
CT.gov ID
NCT02102230
Collaborator
(none)
111
1
3
28.6
3.9
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Study Type:
Interventional
Actual Enrollment
:
111 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
The Impact of CBT-I on Cannabis Cessation Outcomes
Actual Study Start Date
:
Nov 3, 2014
Actual Primary Completion Date
:
Mar 24, 2017
Actual Study Completion Date
:
Mar 24, 2017
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: CBT-I Group Cognitive-Behavioral Therapy for Insomnia (CBT-I) |
Behavioral: 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.
Other Names:
|
| Active Comparator: CBT-I-MA Group Cognitive-Behavioral Therapy for Insomnia Plus Mobile App (CBT-I-MA) |
Behavioral: 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.
Other Names:
|
| Placebo Comparator: PC Desensitization Treatment for Insomnia (DTI) |
Behavioral: 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 Names:
|
Outcome Measures
Primary Outcome Measures
- 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
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts 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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | VA Palo Alto Health Care System, Palo Alto, CA | Palo Alto | California | United States | 94304-1290 |
Sponsors and Collaborators
- VA Office of Research and Development
Investigators
- Principal Investigator: Kimberly A Babson, PhD MA BS, VA Palo Alto Health Care System, Palo Alto, CA
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT02102230
Other Study ID Numbers:
- CLIN-016-13F
First Posted:
Apr 2, 2014
Last Update Posted:
Aug 28, 2019
Last Verified:
Jul 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by VA Office of Research and Development
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | CBT-I | CBT-I-MA | Placebo Control (PC) |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. |
| Period Title: Overall Study | |||
| STARTED | 42 | 28 | 41 |
| COMPLETED | 25 | 11 | 24 |
| NOT COMPLETED | 17 | 17 | 17 |
Baseline Characteristics
| Arm/Group Title | CBT-I | CBT-I-MA | Placebo | Total |
|---|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. | Total of all reporting groups |
| Overall Participants | 25 | 11 | 24 | 60 |
| Age (Count of Participants) | ||||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
25
100%
|
11
100%
|
24
100%
|
60
100%
|
| >=65 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Age (years) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [years] |
46.08
(17.49)
|
44.27
(13.24)
|
52.46
(14.79)
|
48.34
(15.83)
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
1
4%
|
1
9.1%
|
1
4.2%
|
3
5%
|
| Male |
24
96%
|
10
90.9%
|
23
95.8%
|
57
95%
|
| Ethnicity (NIH/OMB) (Count of Participants) | ||||
| Hispanic or Latino |
3
12%
|
1
9.1%
|
2
8.3%
|
6
10%
|
| Not Hispanic or Latino |
20
80%
|
9
81.8%
|
20
83.3%
|
49
81.7%
|
| Unknown or Not Reported |
2
8%
|
1
9.1%
|
2
8.3%
|
5
8.3%
|
| Race (NIH/OMB) (Count of Participants) | ||||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
1
4.2%
|
1
1.7%
|
| Asian |
1
4%
|
0
0%
|
0
0%
|
1
1.7%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
3
12%
|
3
27.3%
|
6
25%
|
12
20%
|
| White |
17
68%
|
6
54.5%
|
14
58.3%
|
37
61.7%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
4
16%
|
2
18.2%
|
3
12.5%
|
9
15%
|
| Region of Enrollment (Count of Participants) | ||||
| United States |
25
100%
|
11
100%
|
24
100%
|
60
100%
|
| marijuana use episodes per week (uses/week) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [uses/week] |
12.0051
(12.04773)
|
8.0583
(7.59805)
|
9.5079
(13.31989)
|
10.3
(12.0)
|
Outcome Measures
| Title | Change in Cannabis Use Frequency Over Time |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Veteran Cannabis Users |
| Arm/Group Title | CBT-I | CBT-I-MA | Placebo |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. |
| Measure Participants | 25 | 11 | 24 |
| baseline |
12.0051
(12.04773)
|
8.0583
(7.59805)
|
9.5079
(13.31989)
|
| 6-weeks post-baseline |
11.5714
(13.11763)
|
12.6071
(7.58119)
|
19.6339
(49.16600)
|
| 2-weeks post-quit |
12.9176
(17.13794)
|
10.0476
(6.30247)
|
7.5663
(11.02617)
|
| 4 weeks post-quit |
13.6964
(19.53661)
|
11.3810
(7.42628)
|
4.9388
(4.71061)
|
| 6-months post-quit |
14.1378
(22.69275)
|
17.0000
(4.24264)
|
8.7385
(9.77943)
|
| Title | Point Prevalence Abstinence Over the Three Post-quit Attempt Assessments |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | CBT-I | CBT-I-MA | Placebo |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. |
| Measure Participants | 25 | 11 | 24 |
| number abstinent at 2 weeks post tx |
0
0%
|
0
0%
|
0
0%
|
| number abstinent at 4 weeks post tx |
0
0%
|
0
0%
|
0
0%
|
| number abstinent at 6 months |
0
0%
|
0
0%
|
0
0%
|
| Title | Change in Self-reported Sleep Quality Over Time |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | CBT-I | CBT-I-MA | Placebo |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. |
| Measure Participants | 25 | 11 | 24 |
| Count of Participants [Participants] |
NA
NaN
|
NA
NaN
|
NA
NaN
|
| Title | Change in Objective Sleep Quality Over Time |
|---|---|
| Description | Objective sleep quality will be measured via actigraphy |
| Time Frame | 2-weeks post-quit, 4-weeks post-quit, 6-months post-quit |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | CBT-I | CBT-I-MA | Placebo |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. |
| Measure Participants | 25 | 11 | 24 |
| Count of Participants [Participants] |
NA
NaN
|
NA
NaN
|
NA
NaN
|
Adverse Events
| Time Frame | Duration of study participation - 6 weeks of tx + 6 months safety f/u | |||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | No difference | |||||
| Arm/Group Title | CBT-I | CBT-I-MA | Placebo | |||
| Arm/Group Description | 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. | 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. | 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. | |||
All Cause Mortality |
||||||
| CBT-I | CBT-I-MA | Placebo | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/25 (0%) | 0/11 (0%) | 0/24 (0%) | |||
Serious Adverse Events |
||||||
| CBT-I | CBT-I-MA | Placebo | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/25 (0%) | 0/11 (0%) | 0/24 (0%) | |||
Other (Not Including Serious) Adverse Events |
||||||
| CBT-I | CBT-I-MA | Placebo | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/25 (0%) | 0/11 (0%) | 0/24 (0%) | |||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Kimberly Babson, PhD |
|---|---|
| Organization | VA Palo Alto Health Care System |
| Phone | 831-325-1540 |
| kimberly.babson@gmail.com |
Responsible Party:
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT02102230
Other Study ID Numbers:
- CLIN-016-13F
First Posted:
Apr 2, 2014
Last Update Posted:
Aug 28, 2019
Last Verified:
Jul 1, 2019