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| ID | Type | Description | Link |
|---|---|---|---|
| R21MH067184 | U.S. NIH Grant/Contract | View source | |
| DATR A2-AID |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
This study will determine the effectiveness of cognitive behavioral therapy (CBT) in treating insomnia symptoms that are secondary to depression. This study will also determine how long the benefits of CBT will last and how the recurrence of insomnia is associated with the onset of new depressive episodes.
Insomnia, characterized by an inability to initiate and maintain sleep, is a defining feature of mood disorders such as depression. CBT has been found to be an effective treatment for depression-related insomnia. This study will determine the effectiveness of CBT in treating insomnia that is secondary to depression. In addition, this study will assess the relationship between insomnia and depression, since previous studies have shown that insomnia may not only be a symptom of depression but may also indicate the onset of a depressive episode.
Participants will be randomly assigned to receive weekly sessions of either CBT or clinician monitoring for 8 weeks. Participants in both groups will meet with a therapist at selected visits, but only CBT participants will receive actual therapy. All participants will have 13 study visits; four will be overnight visits in a sleep lab. On Visit 1, participants will complete questionnaires about their sleep quality and symptoms of depression. Participants will also undergo a physical exam and will begin a daily sleep diary. Visits 2, 3, 12, and 13 will be overnight visits in the sleep lab. During these visits, participants will have electrodes placed on their bodies and a polysomnograph will be used to monitor their sleep. Participants will meet with their therapist on Visits 4 to 11. Participants' sleep diaries, depression scales, and sleep scales will be used for assessment. After the intervention part of the study is complete, participants will have monthly follow-up visits for up to 2 years. During the follow-up visits, participants will complete questionnaires about their sleep quality and symptoms of depression.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive behavioral therapy (CBT) for insomnia | Behavioral | |||
| Clinician monitoring | Behavioral |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment outcome of patients receiving CBT compared to clinician monitoring |
| Measure | Description | Time Frame |
|---|---|---|
| Association between rapid eye movement (REM) latency and treatment outcome |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Perlis, PhD | University of Rochester Sleep Research Lab | Principal Investigator |
| Michael Privitera, MD | Department of Psychiatry, University of Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester Sleep and Neurophysiology Research Lab | Rochester | New York | 14642 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15283007 | Background | Perlis ML, Smith MT, Orff H, Enright T, Nowakowski S, Jungquist C, Plotkin K. The effects of modafinil and cognitive behavior therapy on sleep continuity in patients with primary insomnia. Sleep. 2004 Jun 15;27(4):715-25. doi: 10.1093/sleep/27.4.715. | |
| 11772681 | Background | Smith MT, Perlis ML, Park A, Smith MS, Pennington J, Giles DE, Buysse DJ. Comparative meta-analysis of pharmacotherapy and behavior therapy for persistent insomnia. Am J Psychiatry. 2002 Jan;159(1):5-11. doi: 10.1176/appi.ajp.159.1.5. |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| D012893 |
| Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |