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 Background Information |
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Insomnia is one of the most common reasons for referral to mental health services in active duty personnel. Insomnia often develops into a chronic problem that is characterized by a unique set of nighttime symptoms and daytime impairments. Such impairments include:
-Feeling tired throughout the day
-Being easily irritated and grumpy
-Lack of concentration or memory
-Unable to stay awake during the day
-Decreased level of energy
-Lack of motivation
-Decrease in level of performance at work or in school
-Frustration about your sleep or about falling asleep
Post-Deployment insomnia may reflect the persistence of heightened arousal during sleep, and irregular sleep-wake schedules acquired during the high-demand context of deployment and military operations.
Sleep disturbances are common after returning home.
The goal of this study is to adapt and test the effects of a brief behavioral treatment that targets chronic insomnia (lasting >1 month) in service members returning for Operation Iraqi Freedom (OIF) and Operation Enduring Freedom (OEF).
Male and female veterans 18 years and older who experience these symptoms, and report sleep complaints are being invited to participate in this research study.
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| Study Treatment |
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You will receive a brief behavioral, non-medication treatment for insomnia.
The intervention will be administered over 4 weeks. The sessions will consist of weekly individual, 20- 45 minute intervention sessions.
There are two 45-minute intervention sessions delivered on weeks 1 and 3, 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.
On week 2 and 4, you have a telephone appointment (< 20 minutes to address any difficulty you may experience with the treatment, and to answer questions you may have, and to complete weekly ratings of your symptoms and side effects.
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| Study Procedures |
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***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 up to 3 visits:
-face-to-face meeting to complete interviews and questionnaires
-physical examination
-sleep screening study. This last step involves sleeping in the laboratory for one entire night for a Sleep Apnea evaluation
***Phase 2:***
Intervention Phase, if you are eligible, you will continue in the intervention phase, which is delivered over 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 visit for addressing questions and reviewing progress; scheduling visit to return sleep diary and the actigraph, and to complete the interviews and questionnaires. (<20 minutes).
*** Phase 3:***
Post treatment,
At the end of the four-week period, we will ask you to complete the interviews and questionnaires, and the sleep diary and actigraph again. The interviews and questionnaires will be completed at UPMC, and will require between 90 and 120 minutes. During the debriefing interview, we will also ask your ideas about what was difficult during the intervention and about the study.
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| Timeline |
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The total duration of your participation in the study will be 6 to 7 weeks.
Phase 1: Screening Phase-up to 2 weeks for baseline assessments
Phase 2: Acute Intervention Phase- 4 weeks for the interventions
Phase 3: Post Treatment- 1 week to complete the end-of-intervention assessments
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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 6 years following the end of the research study, whichever is later.
To help us protect your privacy, we have applied for a Certificate of Confidentiality from the National Institutes of Mental Health as of 8 July 2008. 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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Some participants may benefit from the sleep evaluation and treatment interventions. Also, findings from the study will provide new insights into sleep focused interventions in the treatment of insomnia.
The possible risks of this research study may be from the health and physical examination, sleep screening study, sleep intervention, sleep restriction if currently pregnant, completing the in-person interviews and questionnaires that include self-disclosure of illegal activities, or from a breach of confidentiality.
Risks from blood draws: Blood samples drawn by venipuncture are associated with common risks (occurs in 10-25% or 10 to 25 out of 100 people) of pain, bleeding, and bruising at the site, and a rare risk (occurs in less than 1% or less than 1 out of 100 people) of infection and fainting. Risks associated with venipuncture will be minimized by having trained staff take the samples under aseptic condition.
Risk from sleep screening study:
During your sleep screening study, small metal discs, called electrodes, are applied to your face, scalp, and legs, using tape and paste. The technologist will also apply electrodes to check your heart rhythm (electrocardiogram or ECG). Electrode placement for EEG, EOG, EMG, and ECG recordings requires cleaning the skin with a slightly abrasive cream to maximize signal conduction. This may be accompanied by mild skin irritation. Skin irritation is common (occurs in 10-25% or 10 to 25 out of 100 participants). Electrode-related skin irritation can be minimized by using hypoallergenic tape, and by using non-prescription topical steroid cream for a day or two if skin irritation occurs.
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 (occurs in 10-25% or 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 intervention 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.
Sleep restriction may be a risk to pregnant women:
Because participation in this study may harm a pregnancy, you must not become pregnant while you are in this study. You and any person with whom you have sex must use an approved form of birth control. If you do become pregnant, you must tell your doctor at once. If you are a women and you are able to become pregnant, you will have urine pregnancy test to make sure that you are not pregnant before you are permitted to undergo the intervention. If you have any questions, you are encouraged to speak with either the study doctor or your personal physician. The risk on pregnancy is unknown, however, pregnancy itself is known to be associated with sleep disruption and increased daytime sleepiness. Therefore, we do not anticipate that the risk of increased sleepiness for pregnancy will be significantly increased.
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% or 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. All information, assessments, videotapes, 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. |
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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 study, 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 $195 for completing sleep dairies, the interviews, questionnaires, in-lab sleep study before the intervention phase, and also for completing the post treatment visit. |
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