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| Studies for Veterans Only - ISFeRe Study |
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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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