Trial Outcomes & Findings for Treating People With Post-Traumatic Stress Disorder With Cognitive Behavioral Therapy for Insomnia (NCT NCT00881647)
NCT ID: NCT00881647
Last Updated: 2014-03-17
Results Overview
In a self-report sleep diary, participants were asked to report the length of time it takes from lying down for the night until sleep onset. This outcome consists of the posttreatment (CBT-I) or post-waitlist diary entry; In other words, each of the values below was measured at 8 weeks.
COMPLETED
NA
45 participants
After 8 weeks of study participation
2014-03-17
Participant Flow
Participant milestones
| Measure |
CBT-I
8-week course of Cognitive Behavioral Treatment for Insomnia (CBT-I): CBT-I includes strategies and instructions targeted toward improving the quality of sleep and resolving problems falling and staying asleep
|
Waitlist
Participants placed on a waitlist for 8 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
29
|
16
|
|
Overall Study
COMPLETED
|
27
|
15
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Treating People With Post-Traumatic Stress Disorder With Cognitive Behavioral Therapy for Insomnia
Baseline characteristics by cohort
| Measure |
CBT-I
n=29 Participants
8-week course of Cognitive Behavioral Treatment for Insomnia (CBT-I): CBT-I includes strategies and instructions targeted toward improving the quality of sleep and resolving problems falling and staying asleep
|
Waitlist
n=16 Participants
Participants placed on a waitlist for 8 weeks.
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37.1 years
STANDARD_DEVIATION 10.4 • n=99 Participants
|
37.3 years
STANDARD_DEVIATION 11.0 • n=107 Participants
|
37.2 years
STANDARD_DEVIATION 10.5 • n=206 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
29 participants
n=99 Participants
|
16 participants
n=107 Participants
|
45 participants
n=206 Participants
|
|
Marital Status
Single
|
20 participants
n=99 Participants
|
10 participants
n=107 Participants
|
30 participants
n=206 Participants
|
|
Marital Status
Married/Partnered
|
6 participants
n=99 Participants
|
2 participants
n=107 Participants
|
8 participants
n=206 Participants
|
|
Marital Status
Divorced
|
3 participants
n=99 Participants
|
3 participants
n=107 Participants
|
6 participants
n=206 Participants
|
|
Marital Status
Separated
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Veteran Status
Veteran
|
3 participants
n=99 Participants
|
6 participants
n=107 Participants
|
9 participants
n=206 Participants
|
|
Veteran Status
Not veteran
|
26 participants
n=99 Participants
|
10 participants
n=107 Participants
|
36 participants
n=206 Participants
|
|
PTSD Duration
|
20.4 years
STANDARD_DEVIATION 13.6 • n=99 Participants
|
15.0 years
STANDARD_DEVIATION 13.8 • n=107 Participants
|
18.5 years
STANDARD_DEVIATION 2.1 • n=206 Participants
|
|
Current Depression
Depressed
|
5 participants
n=99 Participants
|
4 participants
n=107 Participants
|
9 participants
n=206 Participants
|
|
Current Depression
Not depressed
|
24 participants
n=99 Participants
|
12 participants
n=107 Participants
|
36 participants
n=206 Participants
|
|
Using psychotropic medication
Using psychotropic medication
|
11 participants
n=99 Participants
|
7 participants
n=107 Participants
|
18 participants
n=206 Participants
|
|
Using psychotropic medication
Not using psychotropic medication
|
18 participants
n=99 Participants
|
9 participants
n=107 Participants
|
27 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: After 8 weeks of study participationIn a self-report sleep diary, participants were asked to report the length of time it takes from lying down for the night until sleep onset. This outcome consists of the posttreatment (CBT-I) or post-waitlist diary entry; In other words, each of the values below was measured at 8 weeks.
Outcome measures
| Measure |
CBT-I
n=27 Participants
8-week course of Cognitive Behavioral Treatment for Insomnia (CBT-I): CBT-I includes strategies and instructions targeted toward improving the quality of sleep and resolving problems falling and staying asleep
|
Waitlist
n=15 Participants
Participants placed on a waitlist for 8 weeks.
|
|---|---|---|
|
Sleep Latency (SL)
|
14.27 minutes
Standard Deviation 2.27
|
44.31 minutes
Standard Deviation 11.72
|
PRIMARY outcome
Timeframe: After 8 weeks of study participationPopulation: per protocol
WASO was the sum of wake time during sleep as recorded in a self-report sleep diary, and as measured in epochs (30 seconds of polysomnography \[PSG\]) recording) after the onset of persistent sleep and prior to final awakening and wake time after sleep (the number of epochs after the final awakening until the end of PSG recording \[i.e. awake epoch immediately prior to the end of the recording\]). This outcome consists of posttreatment (CBT-I) or post-waitlist diary entries and polysomnography data; In other words, each of the values below was measured at 8 weeks.
Outcome measures
| Measure |
CBT-I
n=27 Participants
8-week course of Cognitive Behavioral Treatment for Insomnia (CBT-I): CBT-I includes strategies and instructions targeted toward improving the quality of sleep and resolving problems falling and staying asleep
|
Waitlist
n=15 Participants
Participants placed on a waitlist for 8 weeks.
|
|---|---|---|
|
Minutes of Wake After Sleep Onset (WASO)
WASO by self report
|
13.82 Minutes
Standard Deviation 2.03
|
47.25 Minutes
Standard Deviation 11.45
|
|
Minutes of Wake After Sleep Onset (WASO)
WASO by PSG
|
39.25 Minutes
Standard Deviation 7.73
|
57.63 Minutes
Standard Deviation 18.28
|
PRIMARY outcome
Timeframe: After 8 weeks of study participationSE, as determined by polysomnography (PSG) and by self-reported sleep diary, was the total sleep time (TST) divided by the time in bed, multiplied by 100. This outcome consists of posttreatment (CBT-I) or post-waitlist diary entries and polysomnography data; In other words, each of the values below was measured at 8 weeks.
Outcome measures
| Measure |
CBT-I
n=27 Participants
8-week course of Cognitive Behavioral Treatment for Insomnia (CBT-I): CBT-I includes strategies and instructions targeted toward improving the quality of sleep and resolving problems falling and staying asleep
|
Waitlist
n=15 Participants
Participants placed on a waitlist for 8 weeks.
|
|---|---|---|
|
Sleep Efficiency (SE)
SE by self-report
|
93.72 percentage of time
Standard Deviation 0.93
|
81.77 percentage of time
Standard Deviation 2.47
|
|
Sleep Efficiency (SE)
SE by PSG
|
91.35 percentage of time
Standard Deviation 1.91
|
88.14 percentage of time
Standard Deviation 3.59
|
Adverse Events
CBT-I
Waitlist
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Thomas C. Neylan, MD
University of California, San Francisco
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place