Assessing Cognitive Behavioral Therapy for Insomnia to Improve Sleep Outcomes in Individuals With a Concussion: Protocol for a Delayed Randomized Controlled Trial
BackgroundSleep disturbances post concussion have been associated with more frequent and severe concussion symptoms and may contribute to poorer recovery. Cognitive behavioral therapy for insomnia (CBT-I) is an effective treatment for insomnia; however, it remains unclear if...
| Main Authors: | , , , , , , , |
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| Format: | Article |
| Language: | English |
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JMIR Publications
2022-09-01
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| Series: | JMIR Research Protocols |
| Online Access: | https://www.researchprotocols.org/2022/9/e38608 |
| _version_ | 1797734719839797248 |
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| author | Rebecca Ludwig Michael Rippee Linda J D’Silva Jeff Radel Aaron M Eakman Jill Morris Michelle Drerup Catherine Siengsukon |
| author_facet | Rebecca Ludwig Michael Rippee Linda J D’Silva Jeff Radel Aaron M Eakman Jill Morris Michelle Drerup Catherine Siengsukon |
| author_sort | Rebecca Ludwig |
| collection | DOAJ |
| description |
BackgroundSleep disturbances post concussion have been associated with more frequent and severe concussion symptoms and may contribute to poorer recovery. Cognitive behavioral therapy for insomnia (CBT-I) is an effective treatment for insomnia; however, it remains unclear if this treatment method is effective in improving sleep outcomes and reducing concomitant postconcussion symptoms.
ObjectiveThe hypotheses for this study are that (1) CBT-I will improve sleep outcomes and (2) CBT-I will improve concomitant postconcussion symptoms.
MethodsIn total, 40 individuals who are within ≥4 weeks of postconcussion injury and have insomnia symptoms will be enrolled in this randomized controlled trial. Participants will be randomized into either a group that starts a 6-week CBT-I program immediately after baseline or a waitlist control group that starts CBT-I following a 6-week waiting period. All participants will be reassessed 6, 12, and 18 weeks after baseline. Standardized assessments measuring sleep outcomes, postconcussion symptoms, and mood will be used. Linear regression and t tests will be used for statistical analyses.
ResultsEnrollment of 40 participants was completed July 2022, data collection will be completed in November 2022, and publication of main findings is anticipated in May 2023. It is anticipated that participants experience reduced insomnia symptoms and postconcussion symptoms following CBT-I and these improvements will be retained for at least 12 weeks. Additionally, we expect to observe a positive correlation between sleep and postconcussion symptom improvement.
ConclusionsSuccessful completion of this pilot study will allow for a better understanding of the treatment of insomnia and postconcussion symptoms in individuals following a concussion.
Trial RegistrationClinicalTrials.gov NCT04885205; https://clinicaltrials.gov/ct2/show/NCT04885205
International Registered Report Identifier (IRRID)DERR1-10.2196/38608 |
| first_indexed | 2024-03-12T12:48:27Z |
| format | Article |
| id | doaj.art-736c372c3ff241c79a8dd5f44b9a3c65 |
| institution | Directory Open Access Journal |
| issn | 1929-0748 |
| language | English |
| last_indexed | 2024-03-12T12:48:27Z |
| publishDate | 2022-09-01 |
| publisher | JMIR Publications |
| record_format | Article |
| series | JMIR Research Protocols |
| spelling | doaj.art-736c372c3ff241c79a8dd5f44b9a3c652023-08-28T23:07:30ZengJMIR PublicationsJMIR Research Protocols1929-07482022-09-01119e3860810.2196/38608Assessing Cognitive Behavioral Therapy for Insomnia to Improve Sleep Outcomes in Individuals With a Concussion: Protocol for a Delayed Randomized Controlled TrialRebecca Ludwighttps://orcid.org/0000-0002-0029-6361Michael Rippeehttps://orcid.org/0000-0001-8000-7015Linda J D’Silvahttps://orcid.org/0000-0002-3827-0730Jeff Radelhttps://orcid.org/0000-0002-9620-7414Aaron M Eakmanhttps://orcid.org/0000-0002-4294-5286Jill Morrishttps://orcid.org/0000-0001-5911-4190Michelle Dreruphttps://orcid.org/0000-0001-7969-8787Catherine Siengsukonhttps://orcid.org/0000-0002-7706-6804 BackgroundSleep disturbances post concussion have been associated with more frequent and severe concussion symptoms and may contribute to poorer recovery. Cognitive behavioral therapy for insomnia (CBT-I) is an effective treatment for insomnia; however, it remains unclear if this treatment method is effective in improving sleep outcomes and reducing concomitant postconcussion symptoms. ObjectiveThe hypotheses for this study are that (1) CBT-I will improve sleep outcomes and (2) CBT-I will improve concomitant postconcussion symptoms. MethodsIn total, 40 individuals who are within ≥4 weeks of postconcussion injury and have insomnia symptoms will be enrolled in this randomized controlled trial. Participants will be randomized into either a group that starts a 6-week CBT-I program immediately after baseline or a waitlist control group that starts CBT-I following a 6-week waiting period. All participants will be reassessed 6, 12, and 18 weeks after baseline. Standardized assessments measuring sleep outcomes, postconcussion symptoms, and mood will be used. Linear regression and t tests will be used for statistical analyses. ResultsEnrollment of 40 participants was completed July 2022, data collection will be completed in November 2022, and publication of main findings is anticipated in May 2023. It is anticipated that participants experience reduced insomnia symptoms and postconcussion symptoms following CBT-I and these improvements will be retained for at least 12 weeks. Additionally, we expect to observe a positive correlation between sleep and postconcussion symptom improvement. ConclusionsSuccessful completion of this pilot study will allow for a better understanding of the treatment of insomnia and postconcussion symptoms in individuals following a concussion. Trial RegistrationClinicalTrials.gov NCT04885205; https://clinicaltrials.gov/ct2/show/NCT04885205 International Registered Report Identifier (IRRID)DERR1-10.2196/38608https://www.researchprotocols.org/2022/9/e38608 |
| spellingShingle | Rebecca Ludwig Michael Rippee Linda J D’Silva Jeff Radel Aaron M Eakman Jill Morris Michelle Drerup Catherine Siengsukon Assessing Cognitive Behavioral Therapy for Insomnia to Improve Sleep Outcomes in Individuals With a Concussion: Protocol for a Delayed Randomized Controlled Trial JMIR Research Protocols |
| title | Assessing Cognitive Behavioral Therapy for Insomnia to Improve Sleep Outcomes in Individuals With a Concussion: Protocol for a Delayed Randomized Controlled Trial |
| title_full | Assessing Cognitive Behavioral Therapy for Insomnia to Improve Sleep Outcomes in Individuals With a Concussion: Protocol for a Delayed Randomized Controlled Trial |
| title_fullStr | Assessing Cognitive Behavioral Therapy for Insomnia to Improve Sleep Outcomes in Individuals With a Concussion: Protocol for a Delayed Randomized Controlled Trial |
| title_full_unstemmed | Assessing Cognitive Behavioral Therapy for Insomnia to Improve Sleep Outcomes in Individuals With a Concussion: Protocol for a Delayed Randomized Controlled Trial |
| title_short | Assessing Cognitive Behavioral Therapy for Insomnia to Improve Sleep Outcomes in Individuals With a Concussion: Protocol for a Delayed Randomized Controlled Trial |
| title_sort | assessing cognitive behavioral therapy for insomnia to improve sleep outcomes in individuals with a concussion protocol for a delayed randomized controlled trial |
| url | https://www.researchprotocols.org/2022/9/e38608 |
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