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

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.