Insomnia Clinical Trial
Official title:
Efficacy of Adjunct Sleep Interventions for PTSD
The purpose of this research study is to evaluate and compare the effects of experimental
treatments aimed at improving insomnia and nightmares in men and women military veterans
between the ages of 18 and 60 years old, and who have a condition called Posttraumatic
Stress Disorder. Insomnia refers to difficulty falling or staying asleep, although enough
time is allowed for sleeping. Insomnia is also associated with daytime consequences, such as
lack of energy, irritability, and difficulty concentrating. Nightmares are bad dreams that
may or may not awaken the sleeper, and that cause discomfort during the daytime.
Chronic Posttraumatic Stress Disorder (PTSD) refers to symptoms that occur after someone
experienced or witnessed a life-threatening event, and that persist for three months or more
after the event. Symptoms include flashbacks, nightmares, feelings of detachment from
others, sleep disturbances, irritability, anxiety, and efforts to avoid people and places
associated with the life-threatening event. These symptoms occur after a life-threatening
event. Symptoms that persist for more than one month indicate the presence of PTSD. In the
present study, we will study people with chronic PTSD, which refers to PTSD symptoms that
persist for more than 3 months.
Efficacy of a treatment is defined as the capacity to produce the desired effects. In this
study, we will evaluate and compare the capacity of two active experimental treatments to
reduce insomnia and nightmares associated with PTSD, and one inactive intervention, called a
placebo, for people who continue to have sleep difficulties despite receiving treatment with
an antidepressant medication called a selective serotonin reuptake inhibitor (SSRI, like
Prozac, Paxil, Zoloft, Celexa). The two active experimental treatments are a medication,
prazosin, and a brief behavioral intervention, which involves exercises and techniques to
reduce nightmares and improve sleep quality. Prazosin is an approved medication by the Food
and Drug Administration (FDA) against high blood pressure, but is not FDA-approved for
posttraumatic insomnia and nightmares.
Posttraumatic stress disorder (PTSD) is a prevalent disorder in military samples associated
with adverse emotional and health impacts and enormous health care costs, and it is often
resistant to treatment. Identification of PTSD-related factors that contribute to poor
clinical and health outcomes is imperative to refine treatment strategies. Post deployment
-related sleep disturbances constitute one of the factors that contribute to poor clinical
and health outcomes. PTSD symptoms persist during sleep, but little clinical attention is
typically devoted to nighttime symptoms. Other deployment related stress reactions are
associated with sleep disturbances. Sleep disturbances are resistant to traditional PTSD
treatments. There is emerging evidence that adjunct sleep-focused interventions
(pharmacological or behavioral) are associated with improvements in sleep, daytime
symptomatology, general emotional well being, and functioning. Therefore, sleep focused
interventions may enhance treatment response and clinical outcomes in individuals exposed to
trauma with consequent sleep disturbances. However, the efficacy and durability of adjunct
sleep interventions have not been formally evaluated and compared. In this study, we aim at
comparing the efficacy and durability of interventions targeting sleep disturbances that
occurred in relation to military service and or military deployment.
The overarching objective of this study is to investigate and compare the efficacy and
durability of adjunct sleep-focused interventions on sleep, daytime PTSD symptomatology, and
mood in a sample of 90 male and female veterans who experience nightmares and insomnia. The
specific aims and hypotheses are: 1. To investigate the efficacy of prazosin, integrated
behavioral sleep intervention (IBSI), and placebo (PLA) on post deployment-related sleep
disturbances; 2. To compare the efficacy of pharmacological and behavioral interventions
adjunct sleep focused interventions; 3. To evaluate and compare the durability of active
sleep-focused interventions on sleep, daytime PTSD symptoms, mood, and anxiety by conducting
a naturalistic follow-up assessment 4 months after the end-of-treatment assessment. A
secondary aim is to identify demographic, psychosocial, and clinical predictors of sleep
treatment response in military veterans.
Participants will be recruited from the Pittsburgh VA Health Care System clinics and
services. Treatments will be administered over an eight-week period for all conditions.
Primary outcome measures include (1) Sleep Quality as determined by polysomnographic (sleep)
recordings, and global scores on the Pittsburgh Sleep Quality Index (PSQI) and PSQI Addendum
for PTSD (PSQI-A). Sleep response will be defined as a sleep latency < 30 minutes, and wake
time after sleep onset < 30 minutes, and a sleep efficiency > 85% as determined by sleep
diaries and in-home sleep studies, or a decrease in > 5 points on the Pittsburgh Sleep
Quality Index. Secondary outcome measures include PTSD symptom severity as determined by the
Clinician-Administered PTSD scale, Part 2, and the self-report PTSD Symptom
Checklist-Military version; depression severity (as determined by the Beck Depression
Inventory) anxiety (Beck Anxiety Inventory), (4) health-related quality of life (SF-36). A
naturalistic follow-up assessment will be conducted four months post-treatment.
The proposed study will contribute to the development of effective therapeutic strategies
for PTSD. This study will provide novel information regarding predictors of sleep treatment
response in PTSD, which will contribute to facilitating care management in PTSD.
;
Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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