Post-Traumatic Stress Disorder
Conditions
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
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Sleep Latency (SL) | After 8 weeks of study participation | 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. |
| Minutes of Wake After Sleep Onset (WASO) | After 8 weeks of study participation | 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. |
| Sleep Efficiency (SE) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 |
| Total | 45 |
Baseline characteristics
| Characteristic | Total | Waitlist | CBT-I |
|---|---|---|---|
| Age, Continuous | 37.2 years STANDARD_DEVIATION 10.5 | 37.3 years STANDARD_DEVIATION 11 | 37.1 years STANDARD_DEVIATION 10.4 |
| Current Depression Depressed | 9 participants | 4 participants | 5 participants |
| Current Depression Not depressed | 36 participants | 12 participants | 24 participants |
| Marital Status Divorced | 6 participants | 3 participants | 3 participants |
| Marital Status Married/Partnered | 8 participants | 2 participants | 6 participants |
| Marital Status Separated | 1 participants | 1 participants | 0 participants |
| Marital Status Single | 30 participants | 10 participants | 20 participants |
| PTSD Duration | 18.5 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 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 5 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 1 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 32 Participants | 12 Participants | 20 Participants |
| Region of Enrollment United States | 45 participants | 16 participants | 29 participants |
| Sex: Female, Male Female | 31 Participants | 9 Participants | 22 Participants |
| Sex: Female, Male Male | 14 Participants | 7 Participants | 7 Participants |
| Using psychotropic medication Not using psychotropic medication | 27 participants | 9 participants | 18 participants |
| Using psychotropic medication Using psychotropic medication | 18 participants | 7 participants | 11 participants |
| Veteran Status Not veteran | 36 participants | 10 participants | 26 participants |
| Veteran Status Veteran | 9 participants | 6 participants | 3 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 29 | 0 / 16 |
| serious Total, serious adverse events | 0 / 29 | 0 / 16 |
Outcome results
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CBT-I | Minutes of Wake After Sleep Onset (WASO) | WASO by self report | 13.82 Minutes | Standard Deviation 2.03 |
| CBT-I | Minutes of Wake After Sleep Onset (WASO) | WASO by PSG | 39.25 Minutes | Standard Deviation 7.73 |
| Waitlist | Minutes of Wake After Sleep Onset (WASO) | WASO by self report | 47.25 Minutes | Standard Deviation 11.45 |
| Waitlist | Minutes of Wake After Sleep Onset (WASO) | WASO by PSG | 57.63 Minutes | Standard Deviation 18.28 |
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CBT-I | Sleep Efficiency (SE) | SE by PSG | 91.35 percentage of time | Standard Deviation 1.91 |
| CBT-I | Sleep Efficiency (SE) | SE by self-report | 93.72 percentage of time | Standard Deviation 0.93 |
| Waitlist | Sleep Efficiency (SE) | SE by self-report | 81.77 percentage of time | Standard Deviation 2.47 |
| Waitlist | Sleep Efficiency (SE) | SE by PSG | 88.14 percentage of time | Standard Deviation 3.59 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CBT-I | Sleep Latency (SL) | 14.27 minutes | Standard Deviation 2.27 |
| Waitlist | Sleep Latency (SL) | 44.31 minutes | Standard Deviation 11.72 |