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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01MH137211-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute of Mental Health (NIMH) | NIH |
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This is mechanistic clinical trial that evaluates the role of one of the glutamate receptors (mGluR5) in cognitive behavioral therapy for insomnia (CBT-I) as a common pathway in improving sleep and depression.
Cognitive behavioral therapy for insomnia (CBT-I), a treatment solely aimed at improving sleep, reduces depression with rates similar to conventional antidepressants. Although this efficacy reflects the interrelationship between sleep and depression, CBT-I's antidepressant mechanism of action is currently unknown. One potential mechanistic pathway is through the metabotropic glutamate receptor subtype 5 (mGluR5), due to its strong association with both depression and sleep. The investigators hypothesize that CBT-I's antidepressant efficacy may occur through the downregulation of mGluR5 associated with improved sleep. This study is a mechanistic clinical trial in a cohort of adults with MDD and a range of sleep latencies (time it takes to fall asleep). Prior to and following CBT-I, the investigators will quantify hippocampal mGluR5 density (with using positron emission tomography [PET] imaging) and sleep latency (with polysomnography performed in the Sleep Lab). CBT-I will be delivered through an online program, Sleep Healthy Using The Internet (SHUTi).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive Behavioral Therapy for Insomnia Treatment Arm | Experimental | Cognitive Behavioral Therapy for Insomnia (CBT-I) will be delivered through an online program, Sleep Healthy Using The Internet (SHUTi). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Behavioral Therapy for Insomnia | Behavioral | Cognitive Behavioral Therapy for Insomnia (CBT-I) will be delivered through an online program, Sleep Healthy Using The Internet Sleep Healthy Using The Internet (SHUTi) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Sleep Latency from Baseline to 8 Weeks | Polysomnography: Prior to and following CBT-I, participants will spend one or two nights in the facility's Sleep Lab in order to assess sleep latency (i.e., quantity of sleep). While the participant sleeps, polysomnography, including EEG will be collected. This will be used to quantify sleep latency. | Baseline and 8 Weeks |
| Change from Baseline of mGluR5 density in the hippocampus after 8 weeks of CBT-I Treatment | PET Imaging: Prior to and following CBT-I, participants will receive PET imaging to allow measurement of change in mGluR5 (a protein receptor in the brain) density in the hippocampus. | Baseline and 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wendy Zhang | Contact | (631)-638-2053 | Wendy.Zhang@stonybrookmedicine.edu | |
| Christine DeLorenzo, PhD | Contact | (631) 638-1523 | christine.delorenzo@stonybrookmedicine.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stony Brook University: Dept of Psychiatry | Recruiting | Stony Brook | New York | 11794 | United States |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D020919 | Sleep Disorders, Intrinsic |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D013057 | Spectrum Analysis |
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Prior to and following CBT-I, the investigators will quantify hippocampal mGluR5 density (with PET using [11C]ABP688) and sleep latency (with polysomnography study performed in a Sleep Lab Facility), CBT-I will be delivered through an online program, Sleep Healthy Using The Internet (SHUTi, pronounced "shut eye").
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| PET Scan with [11C]ABP688 | Drug | Prior to and after completing the CBT-I protocol, participants will undergo a PET scan using tracer [11C]ABP688) to quantify hippocampal mGluR5 density. |
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| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D002623 |
| Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |