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| Studies for Veterans Only - ISFeRe Study |
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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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