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CBT-I for Cannabis Use (CBT-I-CU)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02102230
Recruitment Status : Terminated (Principle Investigator as left government service)
First Posted : April 2, 2014
Results First Posted : August 28, 2019
Last Update Posted : August 28, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Conditions Marijuana Abuse
Sleep Initiation and Maintenance Disorders
Interventions Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I)
Behavioral: Cognitive Behavioral Therapy for Insomnia Plus Mobile App (CBT-I-MA)
Behavioral: Desensitization Treatment for Insomnia
Enrollment 111
Recruitment Details  
Pre-assignment Details  
Arm/Group Title CBT-I CBT-I-MA Placebo Control (PC)
Hide 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
Arm/Group Title CBT-I CBT-I-MA Placebo Total
Hide 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 Number of Baseline Participants 25 11 24 60
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 11 participants 24 participants 60 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
25
 100.0%
11
 100.0%
24
 100.0%
60
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 24 participants 11 participants 24 participants 59 participants
46.08  (17.49) 44.27  (13.24) 52.46  (14.79) 48.34  (15.83)
[1]
Measure Analysis Population Description: Age was not obtained from one subject.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 11 participants 24 participants 60 participants
Female
1
   4.0%
1
   9.1%
1
   4.2%
3
   5.0%
Male
24
  96.0%
10
  90.9%
23
  95.8%
57
  95.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 11 participants 24 participants 60 participants
Hispanic or Latino
3
  12.0%
1
   9.1%
2
   8.3%
6
  10.0%
Not Hispanic or Latino
20
  80.0%
9
  81.8%
20
  83.3%
49
  81.7%
Unknown or Not Reported
2
   8.0%
1
   9.1%
2
   8.3%
5
   8.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 11 participants 24 participants 60 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
1
   4.2%
1
   1.7%
Asian
1
   4.0%
0
   0.0%
0
   0.0%
1
   1.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
3
  12.0%
3
  27.3%
6
  25.0%
12
  20.0%
White
17
  68.0%
6
  54.5%
14
  58.3%
37
  61.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
4
  16.0%
2
  18.2%
3
  12.5%
9
  15.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 25 participants 11 participants 24 participants 60 participants
25
 100.0%
11
 100.0%
24
 100.0%
60
 100.0%
marijuana use episodes per week  
Mean (Standard Deviation)
Unit of measure:  Uses/week
Number Analyzed 25 participants 11 participants 24 participants 60 participants
12.0051  (12.04773) 8.0583  (7.59805) 9.5079  (13.31989) 10.3  (12.0)
1.Primary Outcome
Title Change in Cannabis Use Frequency Over Time
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Veteran Cannabis Users
Arm/Group Title CBT-I CBT-I-MA Placebo
Hide 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.

Overall Number of Participants Analyzed 25 11 24
Mean (Standard Deviation)
Unit of Measure: mean uses per period
baseline Number Analyzed 25 participants 11 participants 24 participants
12.0051  (12.04773) 8.0583  (7.59805) 9.5079  (13.31989)
6-weeks post-baseline Number Analyzed 14 participants 4 participants 16 participants
11.5714  (13.11763) 12.6071  (7.58119) 19.6339  (49.16600)
2-weeks post-quit Number Analyzed 13 participants 3 participants 14 participants
12.9176  (17.13794) 10.0476  (6.30247) 7.5663  (11.02617)
4 weeks post-quit Number Analyzed 12 participants 3 participants 14 participants
13.6964  (19.53661) 11.3810  (7.42628) 4.9388  (4.71061)
6-months post-quit Number Analyzed 9 participants 2 participants 9 participants
14.1378  (22.69275) 17.0000  (4.24264) 8.7385  (9.77943)
2.Primary Outcome
Title Point Prevalence Abstinence Over the Three Post-quit Attempt Assessments
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.

Overall Number of Participants Analyzed 25 11 24
Measure Type: Count of Participants
Unit of Measure: Participants
number abstinent at 2 weeks post tx Number Analyzed 12 participants 3 participants 11 participants
0
   0.0%
0
   0.0%
0
   0.0%
number abstinent at 4 weeks post tx Number Analyzed 11 participants 3 participants 12 participants
0
   0.0%
0
   0.0%
0
   0.0%
number abstinent at 6 months Number Analyzed 11 participants 3 participants 12 participants
0
   0.0%
0
   0.0%
0
   0.0%
3.Primary Outcome
Title Change in Self-reported Sleep Quality Over Time
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CBT-I CBT-I-MA Placebo
Hide 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.

Overall Number of Participants Analyzed 25 11 24
Measure Type: Count of Participants
Unit of Measure: Participants
NA [1]  NA [1]  NA [1] 
[1]
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.
4.Primary Outcome
Title Change in Objective Sleep Quality Over Time
Hide Description Objective sleep quality will be measured via actigraphy
Time Frame 2-weeks post-quit, 4-weeks post-quit, 6-months post-quit
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CBT-I CBT-I-MA Placebo
Hide 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.

Overall Number of Participants Analyzed 25 11 24
Measure Type: Count of Participants
Unit of Measure: Participants
NA [1]  NA [1]  NA [1] 
[1]
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.
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
Hide 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 (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   0/11 (0.00%)   0/24 (0.00%) 
Hide Serious Adverse Events
CBT-I CBT-I-MA Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   0/11 (0.00%)   0/24 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
CBT-I CBT-I-MA Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   0/11 (0.00%)   0/24 (0.00%) 
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
Layout table for Results Point of Contact information
Name/Title: Kimberly Babson, PhD
Organization: VA Palo Alto Health Care System
Phone: 831-325-1540
EMail: kimberly.babson@gmail.com
Layout table for additonal information
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02102230    
Other Study ID Numbers: CLIN-016-13F
First Submitted: March 25, 2014
First Posted: April 2, 2014
Results First Submitted: March 19, 2019
Results First Posted: August 28, 2019
Last Update Posted: August 28, 2019