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Treating People With Post-Traumatic Stress Disorder With Cognitive Behavioral Therapy for Insomnia

Cognitive Behavioral Treatment of Insomnia in Posttraumatic Stress Disorder

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00881647
Enrollment
45
Registered
2009-04-15
Start date
2008-11-30
Completion date
2013-04-30
Last updated
2014-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-Traumatic Stress Disorder

Keywords

PTSD, Insomnia Disorder, Insomnia, CBT

Brief summary

This study will test the effectiveness of cognitive behavioral therapy for insomnia in treating sleep disturbances in people with post-traumatic stress disorder.

Detailed description

Cognitive behavioral therapy to treat insomnia (CBT-I) was developed for people with primary insomnia but has been successfully used to treat insomnia in people with other disorders. Insomnia is the most commonly reported complaint of patients receiving treatment for post-traumatic stress disorder (PTSD). Medications are not effective in treating insomnia in people with PTSD, and behavioral treatments, like CBT-I, have not yet been proven effective in these cases. This study will test the effectiveness of CBT-I in alleviating insomnia in people with PTSD. Participation in this study will last 10 months. At study entry, participants will complete a series of eligibility assessments, including a clinical interview, a medical screening, a urine screening for drugs of abuse, a blood test, and a pregnancy test. Then, over 1 week, participants will complete baseline assessments of sleep behaviors. The assessments will include the following: filling out a set of questionnaires about health, mood, sleeping patterns, possible life trauma, and PTSD; filling out a sleep diary every morning to record time slept, times woken up, nightmares, and quality of sleep; wearing a wristwatch-like device, called an Actigraph, that records activity level during wakefulness and sleep; completing a 5-minute psychomotor vigilance task twice a day on a personal digital assistant (PDA); wearing a sensor connected to the finger that detects sleep apnea, called an Oximeter, 1 night while sleeping; and, during the last 2 nights of sleep assessment, having a sleep recorder connected to one's head to measure different stages of sleep. After the week of sleep assessments, participants will be randomly assigned to one of two groups: the CBT-I group or the waitlist group. Participants in the CBT-I group will complete eight weekly therapy sessions targeted at improving quality of sleep and resolving problems with falling and staying asleep. Participants in the waitlist group will not be offered CBT-I treatment until after 8 weeks. During these 8 weeks, all participants will continue to keep a sleep diary, continue wearing the Actigraph, and, in the fourth week, be asked to fill out a questionnaire booklet with similar questions to those completed in the eligibility screening. After 8 weeks, participants will repeat all the sleep assessments performed at baseline. They will also undergo a clinical interview to assess the severity of PTSD symptoms and sleep problems. After the second set of sleep assessments, the waitlist group will be offered CBT-I, and the CBT-I group will complete 6- and 12-month follow-up assessments. These follow-up assessments will involve repeating both the sleep assessments and the clinical interview performed after the 8-week intervention.

Interventions

CBT-I includes strategies and instructions targeted toward improving the quality of sleep and resolving problems falling and staying asleep

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
University of California, San Francisco
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Chronic PTSD for at least 3 months * Currently on first line treatment for PTSD, defined as selective serotonin reuptake inhibitor (SSRI) therapy, for at least 6 months * Persistent residual insomnia

Exclusion criteria

* Conditions or substances that may be associated with comorbid insomnia independent of PTSD

Design outcomes

Primary

MeasureTime frameDescription
Sleep Latency (SL)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.
Minutes of Wake After Sleep Onset (WASO)After 8 weeks of study participationWASO 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.
Sleep Efficiency (SE)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.

Countries

United States

Participant flow

Participants by arm

ArmCount
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
29
Waitlist
Participants placed on a waitlist for 8 weeks.
16
Total45

Baseline characteristics

CharacteristicTotalWaitlistCBT-I
Age, Continuous37.2 years
STANDARD_DEVIATION 10.5
37.3 years
STANDARD_DEVIATION 11
37.1 years
STANDARD_DEVIATION 10.4
Current Depression
Depressed
9 participants4 participants5 participants
Current Depression
Not depressed
36 participants12 participants24 participants
Marital Status
Divorced
6 participants3 participants3 participants
Marital Status
Married/Partnered
8 participants2 participants6 participants
Marital Status
Separated
1 participants1 participants0 participants
Marital Status
Single
30 participants10 participants20 participants
PTSD Duration18.5 years
STANDARD_DEVIATION 2.1
15.0 years
STANDARD_DEVIATION 13.8
20.4 years
STANDARD_DEVIATION 13.6
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
5 Participants2 Participants3 Participants
Race (NIH/OMB)
Black or African American
6 Participants1 Participants5 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
2 Participants1 Participants1 Participants
Race (NIH/OMB)
White
32 Participants12 Participants20 Participants
Region of Enrollment
United States
45 participants16 participants29 participants
Sex: Female, Male
Female
31 Participants9 Participants22 Participants
Sex: Female, Male
Male
14 Participants7 Participants7 Participants
Using psychotropic medication
Not using psychotropic medication
27 participants9 participants18 participants
Using psychotropic medication
Using psychotropic medication
18 participants7 participants11 participants
Veteran Status
Not veteran
36 participants10 participants26 participants
Veteran Status
Veteran
9 participants6 participants3 participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 290 / 16
serious
Total, serious adverse events
0 / 290 / 16

Outcome results

Primary

Minutes of Wake After Sleep Onset (WASO)

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.

Time frame: After 8 weeks of study participation

Population: per protocol

ArmMeasureGroupValue (MEAN)Dispersion
CBT-IMinutes of Wake After Sleep Onset (WASO)WASO by self report13.82 MinutesStandard Deviation 2.03
CBT-IMinutes of Wake After Sleep Onset (WASO)WASO by PSG39.25 MinutesStandard Deviation 7.73
WaitlistMinutes of Wake After Sleep Onset (WASO)WASO by self report47.25 MinutesStandard Deviation 11.45
WaitlistMinutes of Wake After Sleep Onset (WASO)WASO by PSG57.63 MinutesStandard Deviation 18.28
Primary

Sleep Efficiency (SE)

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.

Time frame: After 8 weeks of study participation

ArmMeasureGroupValue (MEAN)Dispersion
CBT-ISleep Efficiency (SE)SE by PSG91.35 percentage of timeStandard Deviation 1.91
CBT-ISleep Efficiency (SE)SE by self-report93.72 percentage of timeStandard Deviation 0.93
WaitlistSleep Efficiency (SE)SE by self-report81.77 percentage of timeStandard Deviation 2.47
WaitlistSleep Efficiency (SE)SE by PSG88.14 percentage of timeStandard Deviation 3.59
Primary

Sleep Latency (SL)

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.

Time frame: After 8 weeks of study participation

ArmMeasureValue (MEAN)Dispersion
CBT-ISleep Latency (SL)14.27 minutesStandard Deviation 2.27
WaitlistSleep Latency (SL)44.31 minutesStandard Deviation 11.72

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026