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 Background Information |
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Post-deployment stress reactions include mood disturbances, anxiety and adjustment symptoms such as intrusions (flashbacks, nightmares), avoidance (e.g., efforts to avoid places, people, and activities that are reminders of stressful events), and arousal (e.g., insomnia, exaggerated startle reactions and anger outburst).
These reactions can persist for more than 3 months after being exposed to or having witnessed a life-threatening event.
Sleep disturbances are common post-deployment.
***The goal of this study is to test the effects of medication and behavioral treatment in those with sleep disturbances.
Male and female veterans between the ages of 18 and 60 who have been exposed to such events, who experience these symptoms, and report sleep complaints are being invited to participate in this research study.
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Study Background through Clinicaltrials.gov
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| Study Treatments |
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****Medication (Prazosin/Placebo) ****
Prazosin is an alpha-1 antagonist agent approved by the Food and Drug Administration (FDA) for the treatment of high blood pressure. It is not approved for the treatment of nightmares and insomnia.
Common side effects (occurring in 1% to 25% of people [1 to 25 out of 100 people]) associated with prazosin includes dizziness, drowsiness, headache, lack of energy, nausea, palpitations (pounding heartbeat), weakness.
Sleepiness or drowsiness related to prazosin could increase risk of accidents while driving or at work. We will check you for side effects every week, and change the dose of medication if needed.
Human studies to evaluate the effects of prazosin on the fetus have not been performed. Therefore, women enrolled in the study will be instructed to use at least two methods of contraception during the acute intervention phase. Prazosin will be provided to you at no cost if you are randomly assigned to the medication arm of the study.
If you receive prazosin, it will begin with a dose of 1 mg each night for the first week. This dose will be increased by 1 mg the following week, and by 2 mg or 4 mg on following weeks if necessary, and as long as you do not have any side effects. The maximum dose you may receive throughout the Acute Intervention Phase is 15 mg. Prazosin is not approved by the Food and Drug Administration (FDA) for the treatment of PTSD-related sleep disturbances. Prazosin is approved by the FDA to treat high blood pressure (hypertension).
Whether you receive prazosin or placebo, you will get four pills to take each night at bedtime. The pills may have medication, or they may have placebo. If you are in the Prazosin group, you will be receiving a mixture of active pills and placebos. Regardless of the experimental treatment you receive, you must take all four pills every night, to make sure that you are receiving the determined amount of the experimental treatments. The pills will come in a container that clearly tells you which pills you take on each day.
****Behavioral Treatment****
If you are randomly assigned to the behavioral sleep intervention; you will receive the treatment aimed at reducing nightmares, insomnia, and behaviors that interfere with sleep and may increase nightmares. The intervention will be administered over 8 weeks. The sessions will consist of individual, 30- to 45-minute intervention sessions.
There are two individual, 45-minute intervention sessions delivered on weeks 1 and 3. A 45-minute "booster" will be conducted on week 5. Thiry-minute face-to-face contacts will be scheduled on every other week (i.e., weeks 2, 4, 6, 7, and 8) to address any difficulty with the intervention instructions and techniques, to answer questions you may have, and to complete weekly ratings of your symptoms and side effects
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Medication (Prazosin) Facts
FDA approved
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| Study Procedures |
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If you are interested in being a part of our study, you must first understand that you are required to come to us at Western Psychiatric Institute and Clinic.
***Phase 1:***
Screening Phase, we ask people to complete questionnaires, interviews, and medical tests. To verify your eligibility and safety to participate in this study. The procedures are done over 3 visits:
-face-to-face meeting to complete interviews and
questionnaires
-physical examination
-sleep screening study. This last step involves sleeping in
the laboratory
***See pictures under "Sleep Lab" tab***
***Phase 2:***
Acute Intervention Phase, which is done over a 1 week period, people who are found to be eligible will be asked to complete questionnaires, a sleep diary for up to 10 consecutive days, and to sleep in the laboratory for two consecutive nights.
Then, we will ask people to come in for one day (for about an hour) a week for 8 consecutive weeks for the test treatment phase.
There are three test treatments in this study: Assignment to one of these three interventions will be determined at random, by a computer program:
-One involves taking an active pill, called prazosin
-On involves modifying behaviors and habits that affect
dreams and sleep quality, called behavioral sleep
intervention
-The last in an inactive pill, called the placebo.
The active phase of this study will be conducted over 8 to 10 weeks, follwed by monthly telephone contacts and a longer telephone interview at 4 months, or 6 months after you entered the study. The total duration of the study is 6 months.
At the end of Phase 2, all participants will again repeat some of the questionnaires and interviews at the end of the intervention phase, complete the sleep diary, and will sleep for two more nights in the sleep laboratory.
***Phase 3:***
Follow-Up Phase, the investigators will keep contact with you each month and you will be asked to complete questionnaires during a telephone interview 4 months after the end of Phase 2.
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| Timeline |
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The study will be conducted over a period of 6 months, in three (3) phases:
Phase 1: Screening Phase- 2 to 3 weeks of your participation. In this phase we will determine if you are eligible to participate in this research study.
Phase 2: Acute Intervention Phase- 10 weeks of your participation. 8 weeks for acute intervention and 2 weeks for evaluation. During this phase you will receive one of the three study experimental treatments.
Phase 3: Follow-Up Phase- 4 months following the end of Phase 2. During this phase we will make telephonic contact with you once a month. You will be asked to complete a telephone interview after 4 months. |
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| Confidentiality |
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Every effort will be made to make sure that the information about you obtained from this study will be kept strictly confidential.
During the course of this research study, we collect private information such as your name, laboratory values regarding blood cell counts, drug and alcohol use, physical exams (blood pressure, height, weight, health condition), and other medical information of past and current physical and mental health and behaviors. Private health information will be kept until your participation in the study is completed, or 5 years following the end of the research study, whichever is later.
To help us protect your privacy, we have obtained a Certificate of Confidentiality from the National Institutes of Mental Health as of 14 August 2006. With this Certificate, the researchers cannot be forced to disclose information that may identify you, even by a court subpoena, in any federal, state, or local civil, criminal, administrative, legislative, or other proceedings. The researchers will use the Certificate to resist any demands for information that would identify you, except under certain circumstances that will be explained to you in detail at your first visit.
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| Benefit/Risk |
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The overall benefit/risk ratio is favorable. Participants may benefit from the active treatment interventions. Also, findings from the study will provide new insights into sleep focused interventions in the treatment of stress disorders.
The possible risks associated with prazosin and this study are:
-sudden withdrawal from the medication
-risk related to possible adverse effects of using prazosin
and medications used for erectile dysfunction (e.g., Viagra,
Cialis, Levitra)
-reproductive risks
-blood draws
-the behavioral sleep intervention
-the laboratory sleep studies
-completing the in-person interviews and questionnaires that
include self-disclosure of illegal activities
-a breach of confidentiality.
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| Compensation |
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*People who are included in this research study will be compensated for their time.
*The physical exam, lab tests, sleep studies, and test treatments will be provided at no costs.
*Parking at the University of Pittsburgh will also be provided at no cost.
*As a compensation for potential inconvenience for participating in the study, participants will receive a total of $275 for completing sleep dairies, the interviews, questionnaires, in-lab sleep studies before and after the intervention phase, and also for completing the 4 follow-up telephone interviews.
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