Trial Outcomes & Findings for Treating People With Post-Traumatic Stress Disorder With Cognitive Behavioral Therapy for Insomnia (NCT 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.

Recruitment status

COMPLETED

Study phase

Target enrollment

45 participants

Primary outcome timeframe

After 8 weeks of study participation

Results posted on

2014-03-17

Participant Flow

Participant milestones

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

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=5 Participants	37.3 years STANDARD_DEVIATION 11.0 • n=7 Participants	37.2 years STANDARD_DEVIATION 10.5 • n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants	9 Participants n=7 Participants	31 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) White	20 Participants n=5 Participants	12 Participants n=7 Participants	32 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	29 participants n=5 Participants	16 participants n=7 Participants	45 participants n=5 Participants
Marital Status Single	20 participants n=5 Participants	10 participants n=7 Participants	30 participants n=5 Participants
Marital Status Married/Partnered	6 participants n=5 Participants	2 participants n=7 Participants	8 participants n=5 Participants
Marital Status Divorced	3 participants n=5 Participants	3 participants n=7 Participants	6 participants n=5 Participants
Marital Status Separated	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Veteran Status Veteran	3 participants n=5 Participants	6 participants n=7 Participants	9 participants n=5 Participants
Veteran Status Not veteran	26 participants n=5 Participants	10 participants n=7 Participants	36 participants n=5 Participants
PTSD Duration	20.4 years STANDARD_DEVIATION 13.6 • n=5 Participants	15.0 years STANDARD_DEVIATION 13.8 • n=7 Participants	18.5 years STANDARD_DEVIATION 2.1 • n=5 Participants
Current Depression Depressed	5 participants n=5 Participants	4 participants n=7 Participants	9 participants n=5 Participants
Current Depression Not depressed	24 participants n=5 Participants	12 participants n=7 Participants	36 participants n=5 Participants
Using psychotropic medication Using psychotropic medication	11 participants n=5 Participants	7 participants n=7 Participants	18 participants n=5 Participants
Using psychotropic medication Not using psychotropic medication	18 participants n=5 Participants	9 participants n=7 Participants	27 participants n=5 Participants

PRIMARY outcome

Timeframe: After 8 weeks of study participation

Outcome measures

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 participation

Population: 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

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 participation

SE, 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

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

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Waitlist

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

Thomas C. Neylan, MD

University of California, San Francisco

Phone: 415-750-6961

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place