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| Studies for Veterans Only - ISFeRe Study |
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 Background Information |
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Sleep disruption following deployment increases the risk of poor outcomes, whereas the persistence of consolidated sleep is associated with psychological resilience. Although sleep disruption is an inherent challenge that characterizes military operations, sleep disruption often persists even after operations are completed. The persistence of chronic sleep disturbances post-deployment compromises psychological resilience, and is associated with heightened risk of occurrence or recurrence of psychiatric disorders in military and civilian population. Sleep disturbances can adversely affect neural circuits involved in threat and reward responses that are involved in the pathophysiology of disorders such as PTSD, MDD and addiction. These neural circuits, the reward and threat circuits, are critical to normal behavior, resilience, and psychiatric disorders.
If sleep disruption, and specifically insomnia, is a threat to psychological resilience (as expressed by increased risk for and prevalence of PTSD, MDD, suicidality, addictive disorders, and other health risk behaviors in adults with chronic insomnia) by disrupting underlying threat and reward brain circuits, then sleep consolidation through effective treatments may normalize aberrant neural threat and reward responses, and enhance psychological resilience or accelerate recovery from chronic, maladaptive stress reactions. To test this hypothesis, we will focus on insomnia, the most prevalent deployment-related sleep disturbance in returning military veterans. We will use the brief behavioral treatment of insomnia – military version (BBTI-MV) to explore whether sleep treatment normalizes threat and reward responses in combat-exposed military veterans using well established fMRI paradigms before and after treatment.
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| Who May Participate |
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We are looking for men who:
• Are military veterans of:
*Operation Enduring Freedom
*Operation Iraqi Freedom
*Operation New Dawn
• Are 18-45 years old
• Are right handed
• Have difficulty falling asleep, staying asleep, or feeling poorly rested despite an adequate amount of time in bed
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| Study Procedures |
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All procedures will take place at Western Psychiatric Institute and Clinic on O’Hara Street in Oakland. Our address is 3811 O’Hara St., Pittsburgh, PA 15213. Parking is provided.
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Screening Phase
1) Telephone Screening (10-15 mins)
You will complete a brief telephone interview in order to determine if you are initially eligible to participate.
2) In-person interviews and questionnaires (1.5-2 hours)
Complete in-person interviews and questionnaires to ensure that you meet eligibility criteria to participate.
3) Physical Health and Physical Examination (approximately 30 mins)
Your next scheduled visit to WPIC will be for a physical health and examination.
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Experimental Procedures
If you qualify to take part in this research study, you will undergo the experimental procedures listed below. These procedures will all take place at WPIC.
1) Sleep Diary and actigraph
You will be asked to complete a sleep diary. The diaries will be given to you at your baseline assesment, and then at week 1 and 3 of the intervention. The diary will be completed in the morning when you wake up, and in the evening, before you go to bed. This will require no more than 5 minutes each time.
Actigraphs are non-intrusive watch-like bracelets, worn on the wrist opposite to your writing hand that allows for monitoring activity level over a series of 24-hour periods in the one’s natural environment. This measure will allow us to estimate your sleep patterns over time. You will be asked to wear the actigraph for the entire duration of the study (6-7 weeks).
2) Testing in the brain scanner (functional magnetic resonance imaging or fMRI)
You will be asked to perform challenging mental tasks on a computer. While you complete the tasks, we will record your heart rate, pupil dilation, skin conductance (sweat), and brain activity using a procedure called functional magnetic resonance imaging (fMRI). An fMRI scan is a test that produces images that are similar to x-ray pictures. fMRI uses a large magnet and does not use any radiation.
You will complete 2 sessions in the magnetic resonance (MR) scanner. You will complete these sessions before and after the intervention phase of the study.
3 ) BBTI-MV Intervention
Following the baseline fMRI, you will begin the intervention phase of the study. This intervention aims to reduce insomnia and behaviors that interfere with sleep. This will be administered over a period of 4 weeks.
* Week 1: Face-to-face visit to learn about sleep and techniques to reduce insomnia (45 minutes)
* Week 2: Telephone contact to review information discussion and address questions and difficulties encountered in the previous week (<20 minutes).
* Week 3: Face-to-face follow-up visit to review of changes to sleep schedule, problem solving (45 minutes)
* Week 4: Telephone contact addressing questions and reviewing progress; scheduling visit to return sleep diary and the actigraph, and to complete the interviews, fMRI, and questionnaires. (<20 minutes).
4) Post-intervention assessment
At the end of the four-week period, we will ask you to complete the interviews and questionnaires, fMRI, and the sleep diary and actigraph again. Completing the evening and morning sleep diary will take no more than 5 minutes each time. You will also be asked to wear the actigraph for another week. The interviews and questionnaires will be completed at WPIC, and will require between 90 and 120 minutes.
If your sleep is not improved at the end of the intervention phase of the study and you provide written consent, you may be offered other treatment options (follow up) to improve your sleep, and/or a follow-up for up to two months with the Principal Investigator or study clinician, until referral is arranged with your primary care physician.
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| Timeline |
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The total duration of the study is designed to accomodate participant's schedules, laboratory, and MR center schedules.
Depending on scheduling accomodations, participation in the study is estimated to be up to 8 weeks.
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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 will collect private information such as your name, Social Security Number, 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. For instance, we will collect information about your past cardiovascular medical history and information about medications you are currently taking. If you have an adverse experience during the course of the study, your entire medical record may be used and disclosed as clinically necessary as well as pursuant to federal and state laws and regulations.
Although disclosing personal information about yourself could violate the Military Code of Conduct, to help us protect your privacy, the investigators will obtain a Certificate of Confidentiality from the National Institutes of Mental Health. 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.
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| Benefit/Risk |
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There is no certain benefit to research subjects from study participation. Data from the clinical assessments may lead to more accurate diagnosis of potential sleep disorders, and to more targeted treatment after study participation. Data from the clinical assessments may lead to additional and more accurate information regarding current psychiatric symptoms, and to appropriate referrals for further evaluation and treatment. Participation in the behavioral program for insomnia may provide some relief of symptoms from insomnia.
The possible risks of this research study may be from the sleep intervention, sleep restriction if currently pregnant, brain scanning sessions, completing the in-person interviews and questionnaires that include self-disclosure of illegal activities, or from a breach of confidentiality.
***Risks from the behavioral intervention: Modifications to your sleep schedule recommended during the behavioral intervention may be associated with increased sleepiness. Sleepiness or drowsiness related to sleep restriction could increase your risk of accidents while driving or at work. Risk for increased daytime sleepiness with BBTI is common (10 to 25 out of 100 participants). We will check you for side effects every week, and change the recommended sleep schedules if needed. If you find the side effects are unbearable, you can discontinue the program at any time, and we will help you to find alternative treatment approaches that may be helpful to you based on information from you baseline assessments.
***Risk of increased distress related to the intervention: Some people may experience increased distress associated with the mild sleep deprivation involved in sleep restriction. Risk for increased daytime sleepiness with BBTI is common (10 to 25 out of 100 participants). Each week during the program, we will ask you how you are feeling relative to the previous week. If you indicate that you experience an increase in distress, we will immediately discuss alternative treatment and referral options with you.
***Risks from the MRI (Infrequent: experienced by 1 to 10 of 100 people): You may experience discomfort, anxiety, or claustrophobia (fearfulness or nervousness when being in an enclosed space). If you experience a fear of the confined space while in the magnet, you can end the study. Noises made by the machine may be bothersome, and flashbacks may be triggered by the noise.
There are no known risks or side effects of the magnetism or radio waves used in MRI. There is the potential risk related to the machine itself attracting metal. The MR. procedure could result in movement of any metal objects in the body, and this movement could result in serious injury. Therefore, if you have metal within your body you will be excluded from the study. Examples of metal objects which may be in a person’s body are: heart pacemaker, aneurysm clip (a metal clip from certain surgeries), ear implant, Intra Uterine Device (IUD), shrapnel (metal from an exploded bomb in combat or from grinding metal objects), neurostimulator (a nerve simulator used to treat pain) or other metal devices. Fear of closed spaces also exclude you from this study. Dental fillings do not present a problem. No other serious side effects have been reported from being inside a magnet. However, if the noise of the MR machine makes you uncomfortable, we can provide you with sound-muffing headphones while in the scan.
***Risks from the in-person evaluation and assessment: Some people feel uncomfortable answering questions of a personal nature, such as questions about mood, and you may self-disclose illegal activities. You can refuse to answer any questions or questionnaires that make you uncomfortable. Psychological discomfort related to interviews and questionnaires infrequently occurs (in less than 10% or less than 10 out of 100 participants).
***Breach of confidentiality: It is possible that information regarding the participants’ psychological health or the content of audiotaped treatment sessions will be discovered by individuals outside of study personnel, despite careful steps to protect confidentiality. Breach of confidentiality rarely occurs (in less than 1 out of 100 participants). Maintaining strict security on information that you provide will minimize these risks. Study data will be kept strictly confidential and participants’ identities will not be revealed in any publication. All participants have subject numbers that will be used on forms and for data storage purposes. The Principal Investigator will have locked files linking participants’ names and identification numbers. No results will be released to employers, ensuring no impact on future insurability or employability. All information, assessments, and audiotapes will be kept in locked files and access to these materials will be limited to study personnel and those involved in the clinical care of participants. The only party outside of the study staff that will have access to identifiable information (names and social security numbers) will be the WePay system of UPMC. Computer databases are protected by several procedures, including password protection of subject data and a firewall around the entire Research Computing Network in the Neuroscience Clinical and Translational Research Center (N-CTRC) at the University of Pittsburgh.
As with any research study, there may be adverse events or side effects that are unknown and it is possible that certain of these unknown risks could be permanent, serious or life-threatening.
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| Compensation |
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| You will be compensated $10 for completing the baseline questionnaires, and $10 for completing at least 7 consecutive days of the sleep diary and actigraphy. You will receive $25 for completing the baseline fMRI session. During the intervention, you will receive $10 for each of the 4 weeks of completed diary and actigraphy day (4 weeks, $40 total). You will receive $10 for completing questionnaires at the post-intervention interview, and $10 for completing at least 7 consecutive days of the sleep diary and actigraphy. For completing the second fMRI session, you will receive an additional $25. Additionally, you may win up to $30 for each of the two scanning sessions (pre- and post-intervention), depending on your performance on the gambling task. In total, you may win up to $60 on the gambling task. This amounts to a maximum total compensation of $190 for completing the entire study. You will only be compensated for the procedures that you complete. |
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