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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01MH101468-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
| US Department of Veterans Affairs | FED |
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The purpose of this study is to evaluate the relative efficacy and effectiveness of specific components of cognitive behavioral therapies for insomnia: sleep restriction (SR) and cognitive therapy (CT) in comparison to combined SR and CT (SR+CT).
As many as one in three older adults may experience insomnia. Older adults are the most frequent users of hypnotic medications. Although safer, use of even the latest "sleeping pills" can lead to cognitive impairment and risk of falls. Thus, it is not surprising that non-pharmacological treatments for insomnia have been pursued as alternatives to medications, with some suggesting they should be the "first line of therapy". We propose a randomized clinical trial to evaluate the relative efficacy and effectiveness of specific components of cognitive behavioral therapies for insomnia (CBT-I): sleep restriction (SR) and cognitive therapy (CT) in comparison to combined SR and CT (SR+CT). We hypothesize that because the proposed mechanisms of action of CT versus SR substantially differ, their combination may have additive effects. Even though the mechanisms of action of SR and CT may differ, no data exists to document that the addition of one to the other provides more overall clinical benefit than either intervention alone. Finally, to better understand "how" and "in whom" SR and CT work, we plan to formally evaluate selected mediators and moderators of the clinical effect including physiological measures of anxiety and arousal. Three treatments (SR, CT, and SR+CT) will be compared in a randomized clinical trial with a parallel groups design. Efficacy and effectiveness data will be collected prior to the beginning of treatment, after 6 weeks of treatment, and at the end of a 6-month follow-up. These efforts follow the National Institute of Mental Health Strategic Plan Strategy 3.1 to develop innovative interventions and designs for intervention studies, in this case, to promote a new intervention trial that focuses on the mediators and moderators of treatment response.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive Behavioral Therapy | Experimental | Cognitive Behavioral Therapy is designed to identify incorrect ideas about sleep, challenge their validity, and replace them with correct information. This therapy tries to reduce worry, anxiety, and fear that one won't sleep by providing accurate information about sleep. |
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| Sleep Restriction | Experimental | Sleep Restriction therapy will limit the time participants spend in bed in order to make sure they are sleepy enough to fall asleep quickly. |
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| Combined Therapy Treatment for Insomnia | Experimental | Combined Therapy involves combining Sleep Restriction and Cognitive Therapy so that the two therapies reinforce each other. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sleep Restriction | Behavioral | Sleep Restriction therapy will limit the time spent in bed in order to make sure participants are sleepy enough to fall asleep quickly. |
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| Measure | Description | Time Frame |
|---|---|---|
| Insomnia Severity Index | Subject's subjective evaluation of their sleep. | Screening, End of 6-week treatment, 6-month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Cognitive Arousal | Score on Penn State Worry Questionnaire, and Dysfunctional Beliefs and Attitudes about Sleep Scale. Both measures have been found to be successful in measuring mediators and moderators of treatment response. | Screening, end of 6-week treatment, 6-month followup |
| Chronic Stress |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jerome A. Yesavage, MD | VA/Stanford | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Palo Alto Health Care System | Palo Alto | California | 94304 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42303834 | Derived | Ahmadi M, Krause AJ, O'Hora KP, Blozyte-Sakenis E, Hernandez B, Lazzeroni LC, Zeitzer JM, Friedman L, Posner D, Kushida C, Manber R, Yesavage J, Saletin JM, Goldstein-Piekarski AN. The association between slow wave activity and memory improvement following cognitive-behavioral therapy for insomnia in older adults: A secondary analysis of a randomized clinical trial . J Clin Sleep Med. 2026 Jun 16;22(1):93. doi: 10.1007/s44470-026-00087-7. | |
| 42271184 | Derived |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D011616 | Psychotherapy, Multiple |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| Cognitive Behavioral Therapy | Behavioral | Cognitive Behavioral Therapy is designed to identify incorrect ideas about sleep, challenge their validity, and replace them with correct information. This therapy tries to reduce worry, anxiety, and fear that one won't sleep by providing accurate information about sleep. |
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| Combined Therapy | Behavioral | Sleep Restriction and Cognitive Therapy will be combined so that the two therapies reinforce each other. |
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We are using two of the most widely utilized psychometric indices of past, present and chronic stress exposure: 1) the Trauma History Questionnaire, and 2) the Life Stressor Checklist revised, a clinical interview for lifetime exposure to stressful life events. |
| Screening, end of 6-week treatment, 6-month followup |
| O'Hora KP, Morehouse AB, Hernandez B, Burda KF, Babros MC, Lazzeroni L, Zeitzer JM, Friedman L, Posner D, Kushida C, Manber R, Yesavage JA, Goldstein-Piekarski AN. Cognitive status moderates long-term benefits of non-pharmacological insomnia therapy in older adults: A secondary analysis of a randomized clinical trial. Alzheimers Dement. 2026 Jun;22(6):e71371. doi: 10.1002/alz.71371. |
| 40476601 | Derived | O'Hora KP, Morehouse AB, Freidman L, Posner D, Ahmadi M, Hernandez B, Burda KF, Kushida C, Zeitzer JM, Lazzeroni LC, Manber R, Yesavage J, Goldstein-Piekarski AN. Comparative effectiveness and predictors of cognitive behavioral therapy for insomnia and its components in older adults: main outcomes of a randomized dismantling trial. J Clin Sleep Med. 2025 Oct 1;21(10):1679-1695. doi: 10.5664/jcsm.11756. |
| D001523 |
| Mental Disorders |