Mechanisms of Change in Cognitive Behavioral Therapy for Insomnia (CBTi) (CBTi)
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- STATUS
- Recruiting
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- days left to enroll
- 18
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- participants needed
- 100
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- sponsor
- University of Arizona
Summary
The purpose of this study is to investigate the mechanisms of change in Cognitive Behavioral Therapy for insomnia (CBTi) in a sample of adults aged 50-65. This study aims to evaluate the pre-post treatment change in sleep, circadian rhythms, biomarkers, cognitive performance, and structural and functional magnetic resonance imaging scans (MRI).
Description
Baseline Part 1:
- Online demographic and contact information
- Schedule Baseline Part 2 with the investigators via online link
- 1 week of daily sleep diaries
Baseline Part 2:
- Internet-based interview with the investigators to confirm study eligibility requirements
- Online self-report questionnaires
- 2 weeks of daily sleep diaries
- 2 weeks of sleep/wake assessment wearing a watch-like activity monitor (Actiwatch)
Objective Baseline:
- Single-night, diagnostic in-home sleep study, including and the following equipment:
- Adhesive patch which will adhere to the arm
- Sensor belts worn around the chest, fitted with nasal canula, pulse oximeter, and 3 electrodes which will adhere to the back of the neck and behind each ear
- Next-day appointment:
- Neuropsychological assessment
- Structural and functional magnetic resonance imaging scan (MRI)
- Non-invasive blood pressure readings
- Low-volume Blood draw (used to obtain genetic biomarkers)
- Removal of adhesive patch
- Next-day evening (2-nights):
- Consumable capsule
- Sensor belt worn around the chest/abdomen Random Assignment: If it is determined the participant is eligible for the study, participants will be randomly assigned to one of the treatment groups (in-person, telehealth or internet delivered) or asked to wait to start treatment.
Treatment Phase I:
- Participants will complete up to 12 weeks of insomnia treatment or wait for treatment ("waitlist") 12-Week Post-treatment Part 1:
- Complete 2 weeks of an online daily sleep diary and actigraphy
- Complete online self-report questionnaires
Objective 12-Week Post-treatment:
• Repeat "Objective Baseline" outlined above
Treatment Phase II (WLC):
- Treatment will start for participants who had been assigned to the waitlist condition 3-Month Follow-Up:
- Complete online self-report questionnaires
Details
| Condition | Sleep Initiation and Maintenance Disorders |
|---|---|
| Treatment | In-Person Cognitive Behavioral Therapy for Insomnia, Telehealth Cognitive Behavioral Therapy for Insomnia, Internet Cognitive Behavioral Therapy for Insomnia |
| Clinical Study Identifier | NCT05226585 |
| Sponsor | University of Arizona |
| Last Modified on | 14 March 2022 |
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
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