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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).
Baseline Part 1:
Baseline Part 2:
Objective Baseline:
Single-night, diagnostic in-home sleep study, including and the following equipment:
Next-day appointment:
Next-day evening (2-nights):
Treatment Phase I:
Objective 12-Week Post-treatment:
• Repeat "Objective Baseline" outlined above
Treatment Phase II (WLC):
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| In-person CBTi | Active Comparator | CBTi of variable treatment length will be administered by trained study staff in-person. |
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| Telehealth CBTi | Active Comparator | CBTi of variable treatment length will be administered by trained study staff via HIPAA-compliant tele-video conference. |
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| Internet CBTi | Active Comparator | Self-paced CBTi of variable treatment length will be administered via Sleep Healthy Using The Internet (SHUTi). |
|
| Waitlist Control | No Intervention | Treatment will be postponed by 12 weeks. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| In-Person Cognitive Behavioral Therapy for Insomnia | Behavioral | Cognitive behavioral therapy is recommended as a first-line treatment for insomnia (CBTi). CBTi contains the following well-validated components of cognitive behavioral treatment for insomnia: stimulus control, sleep compression, sleep hygiene, relaxation training, and cognitive restructuring. |
| Measure | Description | Time Frame |
|---|---|---|
| Insomnia Severity Index | Self-reported severity of insomnia symptoms is assessed once at baseline. | Pre-treatment |
| Insomnia Severity Index | Self-reported severity of insomnia symptoms is assessed weekly through the duration of treatment. | During treatment |
| Insomnia Severity Index | Self-reported severity of insomnia symptoms is assessed once at posttreatment. | 12-week Post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Diary-assessed Sleep | Self-reported severity of sleep parameters (e.g., sleep efficiency, total sleep time, total time in bed). | Pre-treatment |
| Diary-assessed Sleep | Self-reported severity of sleep parameters (e.g., sleep efficiency, total sleep time, total time in bed). |
| Measure | Description | Time Frame |
|---|---|---|
| Circadian Rhythm | Circadian rhythms as assessed by core body temperature | Pre-treatment |
| Circadian Rhythm | Circadian rhythms as assessed by core body temperature |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel J Taylor, Ph.D. | The University of Arizona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Arizona | Tucson | Arizona | 85721 | United States |
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Three treatment arms and a waitlist control
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The participant and outcomes assessor will not be aware of participant study conditions.
|
|
| Telehealth Cognitive Behavioral Therapy for Insomnia | Behavioral | Telehealth cognitive behavioral therapy is recommended as a first-line treatment for insomnia (CBTi) conducted via audio-video communication. tCBTi contains the following well-validated components of cognitive-behavioral treatment for insomnia: stimulus control, sleep compression, sleep hygiene, relaxation training, and cognitive restructuring. |
|
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| Internet Cognitive Behavioral Therapy for Insomnia | Behavioral | Sleep Healthy Using The Internet (SHUTi; aka iCBTi) is a self-guided, fully automated, online CBTi program that includes interactive features: personalized goal setting, graphical feedback based on inputted data, animations/illustrations to enhance comprehension, patient vignettes, and video-based expert explanations. |
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| During treatment |
| Diary-assessed Sleep | Self-reported severity of sleep parameters (e.g., sleep efficiency, total sleep time, total time in bed). | 12 week Post-treatment |
| 12 week Post-treatment |
| Magnetic resonance imaging (MRI) | Neurological outcomes (e.g., MRI resting-state functional connectivity: cingulate cortex, left insula, left cuneus, and fusiform; salience, executive control, and default mode networks.) | Pre-treatment |
| Magnetic resonance imaging (MRI) | Neurological outcomes (e.g., MRI resting-state functional connectivity: cingulate cortex, left insula, left cuneus, and fusiform; salience, executive control, and default mode networks.) | 12 week Post-treatment |
| Inflammatory Health | Cytokines (e.g., IL-6, IL-10, TNFalpha, GFAP, Tau, NFL, UCHL1) | 12 week Pre-treatment |
| Inflammatory Health | Cytokines (e.g., IL-6, IL-10, TNFalpha, GFAP, Tau, NFL, UCHL1) | 12 week Post-treatment |
| Evaluation of executive functioning | Neuropsychological tests of executive functioning using a program administered via iPad | Pre-treatment |
| Evaluation of episodic memory | Neuropsychological tests of episodic memory using a program administered via iPad | Pre-treatment |
| Evaluation of executive functioning | Neuropsychological tests of executive functioning using a program administered via iPad. Due to the nature of these assessments, specific details of the tests cannot be disclosed. | 12 week Post-treatment |
| Evaluation of episodic memory | Neuropsychological tests of episodic memory using a program administered via iPad. Due to the nature of these assessments, specific details of the tests cannot be disclosed. | 12 week Post-treatment |
| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
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