Clinical trial NCT00393874: Efficacy of Sleep Interventions for Posttraumatic Stress Disorder (PTSD)
Official title: Efficacy of Adjunct Sleep Interventions for PTSD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety Disorders
Mood Disorders
Insomnia
Nightmares
Keywords: Anxiety D/O
Mood D/O
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: U.S. Army Medical Research and Development Command
First posted: 2006-10-29
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Military veterans
* Age between 18 and 55 years old
* Reports of insomnia and nightmares
* Current diagnosis of PTSD
* Currently treated with an SSRI.
* Medications and dosages will remain unchanged for the duration of the study
* Participants will agree to remain in ongoing counseling services they may be receiving prior to study entry.
* Able to read and write English
* Provision of written informed consent

Exclusion Criteria:

* Current, severe, untreated Major Depressive Disorder
* Current history of suicidality requiring hospitalization
* Current history (past 6 months) of substance or alcohol abuse
* Currently actively psychotic or bipolar disorder (past year)
* Resting blood pressure \< 90/60 at the screening physical examination
* Heart rate \> 100 beats/minutes
* Use of an alpha-1 antagonist agent or beta-blocker
* Refusal to follow the safety measures
* Unexpected, untreated, or serious EKG findings
* Medications and/or dosage changed in the past two months
* Unstable medical condition
* Pregnant or breast-feeding women
* Apnea-hypopnea index (AHI) \> 15
* Refusal to provide information relevant to selection criteria

Primary outcomes:
measure: Insomnia Severity Index
timeFrame: Screening, Post, and Follow-up
measure: Sleep Diary Measures
timeFrame: baseline and post
measure: PSG Composite Measure
timeFrame: Baseline sleep study and post sleep study
measure: PSQI
timeFrame: Baseline, post, 4 months post-treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Western Phychiatric Institute and Clinic, University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
affiliation: Department of Psychiatry University of Pittsburgh School of Medicine
name: Anne Germain, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Germain A, Richardson R, Moul DE, Mammen O, Haas G, Forman SD, Rode N, Begley A, Nofzinger EA. Placebo-controlled comparison of prazosin and cognitive-behavioral treatments for sleep disturbances in US Military Veterans. J Psychosom Res. 2012 Feb;72(2):89-96. doi: 10.1016/j.jpsychores.2011.11.010. Epub 2011 Dec 20.