Insomnia Clinical Trial
— EASI-POfficial title:
Efficacy of Adjunct Sleep Interventions for PTSD
Verified date | June 2012 |
Source | University of Pittsburgh |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 90 |
Est. completion date | June 2011 |
Est. primary completion date | June 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 55 Years |
Eligibility |
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 |
Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Western Phychiatric Institute and Clinic, University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of Pittsburgh | U.S. Army Medical Research and Materiel Command |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Sleep quality defined by:PIRS 20 and the ISI | Screening, Post, and Follow-up #4 | No | |
Primary | Sleep diaries | Screening, weekly during intervention and post | No | |
Primary | In-lab sleep recordings | Baseline sleep study and post sleep study | No | |
Primary | Pittsburgh Sleep Quality Index (PSQI) | Baseline, post, and follow-up #4 | No | |
Primary | PSQI Addendum for PTSD | Baseline, post, and follow-up #4 | No | |
Secondary | PTSD symptom severity as measured by the CAPS | Screening, baseline and post | Yes | |
Secondary | Depression: BDI | Baseline, Post, and follow-up #4 | Yes | |
Secondary | Anxiety: BAI | Base, post, and follow-up #4 | No | |
Secondary | Health-related quality of life:Quality of Life Enjoyment and Satisfaction Questionnaire and Medical Outcome Survey (SF-36) | Baseline, post, and follow-up #4 | No | |
Secondary | Disability and functioning: Sheehan Disability Scale | Baseline, post, and follow-up #4 | No |
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