Efficacy of Sleep Interventions for Posttraumatic Stress Disorder (PTSD)
Condition: Anxiety Disorders; Mood Disorders; Insomnia; Nightmares
MeSH terms: Anxiety Disorders; Mood Disorders
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Behavioral Sleep Intervention; Prazosin; Placebo
Intervention type(s): Behavioral; Drug; Drug
Intervention description(s): Participants will receive a workbook with information related to the intervention. The three core components are presented and discussed during these sessions are:1) education about sleep and nightmares; 2) imagery rehearsal; 3) stimulus control and sleep restriction. Session 1 focuses on education on PDSD-related insomnia, nightmares, and sleep avoidance behaviors. The rationale for imagery rehearsal will then be presented, and the technique will be practiced once. Strategies for managing intrusive thoughts and images during the practice of imagery rehearsal will be discussed. Participants will be instructed to practice this technique at least three times each day for the duration of the treatment phase. During the second 45-minute session (Week 3), sleep schedules extracted from the pre-intervention sleep diary will be used to identify goals to reduce insomnia, i.e., for sleep restricted schedules, and activities to be performed out of bed when awake.; Participants randomized to PRZ will take 4 capsules each night (PRZ dose complemented with placebo capsules ). The target dose of prazosin is 10 mg. Some individuals may require doses up to 15 mg, (Murray Raskind, M.D., personal communication, February 4, 2005). Prazosin will be administered in an initial oral dose of 1 mg (Week 1), with titration to a maximum of 15 mg. The first increment will be of 1 mg (Week 2: 2 mg), and subsequent weekly increments according to the following schedule: Week 3: 4 mg; Week 4: 6 mg; Week 5: 10 mg; Week 6: 15 mg; Week 7: 15 mg; Week 8: 15 mg. A maximum dose of 15 mg may be necessary. Medication will be administered in a single dose to be taken 30 minutes prior to bedtime because the onset of action occurs within 30 to 90 minutes after a single dose.; Participants randomized to PLA will take 4 capsules each night for eight weeks, all capsules will be identical to prazosin capsules. As for participants randomly assigned to PRZ, they will receive a one-week medication supplies in daily dose dispensers. Similarly, participants will also be instructed to be ready for bed at the time they take the medication, and not to engage in any activities that will prevent them from going to bed.
Other intervention name(s): Behavioral Intervention for Insomnia and Nightmares; MINIPRESS®; Vasoflex®; Hypovase®,; Sugar pill
Intervention MeSH terms: Prazosin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Anxiety D/O; Mood D/O