Trial Outcomes & Findings for CBT-I for Cannabis Use (NCT NCT02102230)
NCT ID: NCT02102230
Last Updated: 2019-08-28
Results Overview
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.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
111 participants
Primary outcome timeframe
baseline, 6-weeks post-baseline, 2-weeks post-quit, 4 weeks post-quit, 6-months post-quit
Results posted on
2019-08-28
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
42
|
28
|
41
|
|
Overall Study
COMPLETED
|
25
|
11
|
24
|
|
Overall Study
NOT COMPLETED
|
17
|
17
|
17
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Age was not obtained from one subject.
Baseline characteristics by cohort
| Measure |
CBT-I
n=25 Participants
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.
|
CBT-I-MA
n=11 Participants
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.
|
Placebo
n=24 Participants
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
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=25 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=60 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
25 Participants
n=25 Participants
|
11 Participants
n=11 Participants
|
24 Participants
n=24 Participants
|
60 Participants
n=60 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=25 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=60 Participants
|
|
Age, Continuous
|
46.08 years
STANDARD_DEVIATION 17.49 • n=24 Participants • Age was not obtained from one subject.
|
44.27 years
STANDARD_DEVIATION 13.24 • n=11 Participants • Age was not obtained from one subject.
|
52.46 years
STANDARD_DEVIATION 14.79 • n=24 Participants • Age was not obtained from one subject.
|
48.34 years
STANDARD_DEVIATION 15.83 • n=59 Participants • Age was not obtained from one subject.
|
|
Sex: Female, Male
Female
|
1 Participants
n=25 Participants
|
1 Participants
n=11 Participants
|
1 Participants
n=24 Participants
|
3 Participants
n=60 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=25 Participants
|
10 Participants
n=11 Participants
|
23 Participants
n=24 Participants
|
57 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=25 Participants
|
1 Participants
n=11 Participants
|
2 Participants
n=24 Participants
|
6 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=25 Participants
|
9 Participants
n=11 Participants
|
20 Participants
n=24 Participants
|
49 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=25 Participants
|
1 Participants
n=11 Participants
|
2 Participants
n=24 Participants
|
5 Participants
n=60 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=25 Participants
|
0 Participants
n=11 Participants
|
1 Participants
n=24 Participants
|
1 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=25 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=25 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=25 Participants
|
3 Participants
n=11 Participants
|
6 Participants
n=24 Participants
|
12 Participants
n=60 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=25 Participants
|
6 Participants
n=11 Participants
|
14 Participants
n=24 Participants
|
37 Participants
n=60 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=25 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=25 Participants
|
2 Participants
n=11 Participants
|
3 Participants
n=24 Participants
|
9 Participants
n=60 Participants
|
|
Region of Enrollment
United States
|
25 Participants
n=25 Participants
|
11 Participants
n=11 Participants
|
24 Participants
n=24 Participants
|
60 Participants
n=60 Participants
|
|
marijuana use episodes per week
|
12.0051 uses/week
STANDARD_DEVIATION 12.04773 • n=25 Participants
|
8.0583 uses/week
STANDARD_DEVIATION 7.59805 • n=11 Participants
|
9.5079 uses/week
STANDARD_DEVIATION 13.31989 • n=24 Participants
|
10.3 uses/week
STANDARD_DEVIATION 12.0 • n=60 Participants
|
PRIMARY outcome
Timeframe: baseline, 6-weeks post-baseline, 2-weeks post-quit, 4 weeks post-quit, 6-months post-quitPopulation: Veteran Cannabis Users
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.
Outcome measures
| Measure |
CBT-I
n=25 Participants
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.
|
CBT-I-MA
n=11 Participants
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.
|
Placebo
n=24 Participants
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.
|
|---|---|---|---|
|
Change in Cannabis Use Frequency Over Time
baseline
|
12.0051 mean uses per period
Standard Deviation 12.04773
|
8.0583 mean uses per period
Standard Deviation 7.59805
|
9.5079 mean uses per period
Standard Deviation 13.31989
|
|
Change in Cannabis Use Frequency Over Time
6-weeks post-baseline
|
11.5714 mean uses per period
Standard Deviation 13.11763
|
12.6071 mean uses per period
Standard Deviation 7.58119
|
19.6339 mean uses per period
Standard Deviation 49.16600
|
|
Change in Cannabis Use Frequency Over Time
2-weeks post-quit
|
12.9176 mean uses per period
Standard Deviation 17.13794
|
10.0476 mean uses per period
Standard Deviation 6.30247
|
7.5663 mean uses per period
Standard Deviation 11.02617
|
|
Change in Cannabis Use Frequency Over Time
4 weeks post-quit
|
13.6964 mean uses per period
Standard Deviation 19.53661
|
11.3810 mean uses per period
Standard Deviation 7.42628
|
4.9388 mean uses per period
Standard Deviation 4.71061
|
|
Change in Cannabis Use Frequency Over Time
6-months post-quit
|
14.1378 mean uses per period
Standard Deviation 22.69275
|
17.0000 mean uses per period
Standard Deviation 4.24264
|
8.7385 mean uses per period
Standard Deviation 9.77943
|
PRIMARY outcome
Timeframe: 2-weeks post-quit, 4 weeks post-quit, 6-months post-quitPopulation: 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.
point prevalence abstinence will be assessed using the Timeline Follow-back measure for cannabis count of number abstinent
Outcome measures
| Measure |
CBT-I
n=25 Participants
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.
|
CBT-I-MA
n=11 Participants
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.
|
Placebo
n=24 Participants
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.
|
|---|---|---|---|
|
Point Prevalence Abstinence Over the Three Post-quit Attempt Assessments
number abstinent at 2 weeks post tx
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Point Prevalence Abstinence Over the Three Post-quit Attempt Assessments
number abstinent at 4 weeks post tx
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Point Prevalence Abstinence Over the Three Post-quit Attempt Assessments
number abstinent at 6 months
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 2-weeks post-quit, 4-weeks post-quit, 6-months post-quitSelf-reported sleep quality will be measured using the Consensus Sleep Diary
Outcome measures
| Measure |
CBT-I
n=25 Participants
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.
|
CBT-I-MA
n=11 Participants
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.
|
Placebo
n=24 Participants
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.
|
|---|---|---|---|
|
Change in Self-reported Sleep Quality Over Time
|
NA Participants
PI is no longer available and project staff could not reconstruct the data and perform the necessary analyses in a manner that would yield valid results.
|
NA Participants
PI is no longer available and project staff could not reconstruct the data and perform the necessary analyses in a manner that would yield valid results.
|
NA Participants
PI is no longer available and project staff could not reconstruct the data and perform the necessary analyses in a manner that would yield valid results.
|
PRIMARY outcome
Timeframe: 2-weeks post-quit, 4-weeks post-quit, 6-months post-quitObjective sleep quality will be measured via actigraphy
Outcome measures
| Measure |
CBT-I
n=25 Participants
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.
|
CBT-I-MA
n=11 Participants
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.
|
Placebo
n=24 Participants
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.
|
|---|---|---|---|
|
Change in Objective Sleep Quality Over Time
|
NA Participants
PI is no longer available and project staff could not reconstruct the data and perform the necessary analyses in a manner that would yield valid results.
|
NA Participants
PI is no longer available and project staff could not reconstruct the data and perform the necessary analyses in a manner that would yield valid results.
|
NA Participants
PI is no longer available and project staff could not reconstruct the data and perform the necessary analyses in a manner that would yield valid results.
|
Adverse Events
CBT-I
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
CBT-I-MA
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place