Sleep to Reduce Incident Depression Effectively (STRIDE): study protocol for a randomized controlled trial comparing stepped-care cognitive-behavioral therapy for insomnia versus sleep education control to prevent major depression
Abstract Background Prevention of major depressive disorder (MDD) is a public health priority. Strategies targeting individuals at elevated risk for MDD may guide effective preventive care. Insomnia is a reliable precursor to depression, preceding half of all incident and relapse cases. Thus, insomn...
| Main Authors: | , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2022-12-01
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| Series: | Trials |
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| Online Access: | https://doi.org/10.1186/s13063-022-06850-4 |
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| author | Christopher L. Drake David A. Kalmbach Philip Cheng Brian K. Ahmedani Edward L. Peterson Christine L. M. Joseph Thomas Roth Kelley M. Kidwell Chaewon Sagong |
| author_facet | Christopher L. Drake David A. Kalmbach Philip Cheng Brian K. Ahmedani Edward L. Peterson Christine L. M. Joseph Thomas Roth Kelley M. Kidwell Chaewon Sagong |
| author_sort | Christopher L. Drake |
| collection | DOAJ |
| description | Abstract Background Prevention of major depressive disorder (MDD) is a public health priority. Strategies targeting individuals at elevated risk for MDD may guide effective preventive care. Insomnia is a reliable precursor to depression, preceding half of all incident and relapse cases. Thus, insomnia may serve as a useful entry point for preventing MDD. Cognitive-behavioral therapy for insomnia (CBT-I) is recommended as the first-line treatment for insomnia, but widespread implementation is limited by a shortage of trained specialists. Innovative stepped-care approaches rooted in primary care can increase access to CBT-I and reduce rates of MDD. Methods/design We propose a large-scale stepped-care clinical trial in the primary care setting that utilizes a sequential, multiple assignment, randomized trial (SMART) design to determine the effectiveness of dCBT-I alone and in combination with clinician-led CBT-I for insomnia and the prevention of MDD incidence and relapse. Specifically, our care model uses digital CBT-I (dCBT-I) as a first-line intervention to increase care access and reduce the need for specialist resources. Our proposal also adds clinician-led CBT-I for patients who do not remit with first-line intervention and need a more personalized approach from specialty care. We will evaluate negative repetitive thinking as a potential treatment mechanism by which dCBT-I and CBT-I benefit insomnia and depression outcomes. Discussion This project will test a highly scalable model of sleep care in a large primary care system to determine the potential for wide dissemination and implementation to address the high volume of population need for safe and effective insomnia treatment and associated prevention of depression. Trial registration ClinicalTrials.gov NCT03322774. Registered on October 26, 2017 |
| first_indexed | 2024-04-11T07:18:18Z |
| format | Article |
| id | doaj.art-e89f2e59dcfb4944bd6193c197c810d5 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-04-11T07:18:18Z |
| publishDate | 2022-12-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-e89f2e59dcfb4944bd6193c197c810d52022-12-22T04:37:51ZengBMCTrials1745-62152022-12-0123111010.1186/s13063-022-06850-4Sleep to Reduce Incident Depression Effectively (STRIDE): study protocol for a randomized controlled trial comparing stepped-care cognitive-behavioral therapy for insomnia versus sleep education control to prevent major depressionChristopher L. Drake0David A. Kalmbach1Philip Cheng2Brian K. Ahmedani3Edward L. Peterson4Christine L. M. Joseph5Thomas Roth6Kelley M. Kidwell7Chaewon Sagong8Thomas Roth Sleep Disorders & Research Center, Henry Ford HealthThomas Roth Sleep Disorders & Research Center, Henry Ford HealthThomas Roth Sleep Disorders & Research Center, Henry Ford HealthCenter for Health Policy & Health Services Research, Henry Ford HealthDepartment of Public Health Services, Henry Ford HealthDepartment of Public Health Services, Henry Ford HealthThomas Roth Sleep Disorders & Research Center, Henry Ford HealthDepartment of Biostatistics, University of MichiganThomas Roth Sleep Disorders & Research Center, Henry Ford HealthAbstract Background Prevention of major depressive disorder (MDD) is a public health priority. Strategies targeting individuals at elevated risk for MDD may guide effective preventive care. Insomnia is a reliable precursor to depression, preceding half of all incident and relapse cases. Thus, insomnia may serve as a useful entry point for preventing MDD. Cognitive-behavioral therapy for insomnia (CBT-I) is recommended as the first-line treatment for insomnia, but widespread implementation is limited by a shortage of trained specialists. Innovative stepped-care approaches rooted in primary care can increase access to CBT-I and reduce rates of MDD. Methods/design We propose a large-scale stepped-care clinical trial in the primary care setting that utilizes a sequential, multiple assignment, randomized trial (SMART) design to determine the effectiveness of dCBT-I alone and in combination with clinician-led CBT-I for insomnia and the prevention of MDD incidence and relapse. Specifically, our care model uses digital CBT-I (dCBT-I) as a first-line intervention to increase care access and reduce the need for specialist resources. Our proposal also adds clinician-led CBT-I for patients who do not remit with first-line intervention and need a more personalized approach from specialty care. We will evaluate negative repetitive thinking as a potential treatment mechanism by which dCBT-I and CBT-I benefit insomnia and depression outcomes. Discussion This project will test a highly scalable model of sleep care in a large primary care system to determine the potential for wide dissemination and implementation to address the high volume of population need for safe and effective insomnia treatment and associated prevention of depression. Trial registration ClinicalTrials.gov NCT03322774. Registered on October 26, 2017https://doi.org/10.1186/s13063-022-06850-4InsomniaDepressionPreventionRCTCBT-IRumination |
| spellingShingle | Christopher L. Drake David A. Kalmbach Philip Cheng Brian K. Ahmedani Edward L. Peterson Christine L. M. Joseph Thomas Roth Kelley M. Kidwell Chaewon Sagong Sleep to Reduce Incident Depression Effectively (STRIDE): study protocol for a randomized controlled trial comparing stepped-care cognitive-behavioral therapy for insomnia versus sleep education control to prevent major depression Trials Insomnia Depression Prevention RCT CBT-I Rumination |
| title | Sleep to Reduce Incident Depression Effectively (STRIDE): study protocol for a randomized controlled trial comparing stepped-care cognitive-behavioral therapy for insomnia versus sleep education control to prevent major depression |
| title_full | Sleep to Reduce Incident Depression Effectively (STRIDE): study protocol for a randomized controlled trial comparing stepped-care cognitive-behavioral therapy for insomnia versus sleep education control to prevent major depression |
| title_fullStr | Sleep to Reduce Incident Depression Effectively (STRIDE): study protocol for a randomized controlled trial comparing stepped-care cognitive-behavioral therapy for insomnia versus sleep education control to prevent major depression |
| title_full_unstemmed | Sleep to Reduce Incident Depression Effectively (STRIDE): study protocol for a randomized controlled trial comparing stepped-care cognitive-behavioral therapy for insomnia versus sleep education control to prevent major depression |
| title_short | Sleep to Reduce Incident Depression Effectively (STRIDE): study protocol for a randomized controlled trial comparing stepped-care cognitive-behavioral therapy for insomnia versus sleep education control to prevent major depression |
| title_sort | sleep to reduce incident depression effectively stride study protocol for a randomized controlled trial comparing stepped care cognitive behavioral therapy for insomnia versus sleep education control to prevent major depression |
| topic | Insomnia Depression Prevention RCT CBT-I Rumination |
| url | https://doi.org/10.1186/s13063-022-06850-4 |
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