Testing delivery of components of cognitive behavioral therapy for insomnia to breast cancer survivors by smart speaker : a study protocol
© 2022. The Author(s)..
BACKGROUND: Insomnia is common in breast cancer survivors (BCS), affecting an estimated 30-50% of the 3.8 million BCS in the US. Insomnia is associated with health consequences for cardiometabolic and immune systems, neurobehavioral function, depression, fatigue, and quality of life and may put BCS at particular risk. While pharmacotherapy for insomnia may address symptoms in the short-term, cognitive behavioral therapy for insomnia (CBT-I) is considered the gold standard insomnia treatment. We describe our protocol to determine the efficacy of voice-activated delivery of CBT-I components on insomnia symptoms compared to a sleep education control among BCS.
METHODS: We will conduct a 6-week, randomized controlled trial with two arms. Intervention arm participants will receive a smart speaker device and will be asked to engage with the program daily, using a voice-activated speaker with an accompanying smart-phone app. Control participants will have access to a website with basic information about CBT-I, sleep, and breast cancer survivorship and will be asked to engage with the website as desired.
DISCUSSION: Our primary outcome is the Insomnia Severity Index total score. Secondary outcomes include sleep diary outcomes (sleep efficiency, wake after sleep onset, sleep onset latency, total sleep time, and sleep quality). This study will provide evidence on a promising modality to deliver elements of CBT-I for BCS experiencing insomnia. Trial Registration ClinicalTrials.gov NCT05233800 Released 3/25/2022.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2022 |
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| Erschienen: |
2022 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:22 |
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| Enthalten in: |
BMC medical informatics and decision making - 22(2022), 1 vom: 21. Juni, Seite 163 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Starling, Claire M [VerfasserIn] |
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| Links: |
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| Themen: |
Breast cancer |
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| Anmerkungen: |
Date Completed 23.06.2022 Date Revised 26.07.2022 published: Electronic ClinicalTrials.gov: NCT05233800 Citation Status MEDLINE |
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| doi: |
10.1186/s12911-022-01902-w |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM342507788 |
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| 500 | |a ClinicalTrials.gov: NCT05233800 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © 2022. The Author(s). | ||
| 520 | |a BACKGROUND: Insomnia is common in breast cancer survivors (BCS), affecting an estimated 30-50% of the 3.8 million BCS in the US. Insomnia is associated with health consequences for cardiometabolic and immune systems, neurobehavioral function, depression, fatigue, and quality of life and may put BCS at particular risk. While pharmacotherapy for insomnia may address symptoms in the short-term, cognitive behavioral therapy for insomnia (CBT-I) is considered the gold standard insomnia treatment. We describe our protocol to determine the efficacy of voice-activated delivery of CBT-I components on insomnia symptoms compared to a sleep education control among BCS | ||
| 520 | |a METHODS: We will conduct a 6-week, randomized controlled trial with two arms. Intervention arm participants will receive a smart speaker device and will be asked to engage with the program daily, using a voice-activated speaker with an accompanying smart-phone app. Control participants will have access to a website with basic information about CBT-I, sleep, and breast cancer survivorship and will be asked to engage with the website as desired | ||
| 520 | |a DISCUSSION: Our primary outcome is the Insomnia Severity Index total score. Secondary outcomes include sleep diary outcomes (sleep efficiency, wake after sleep onset, sleep onset latency, total sleep time, and sleep quality). This study will provide evidence on a promising modality to deliver elements of CBT-I for BCS experiencing insomnia. Trial Registration ClinicalTrials.gov NCT05233800 Released 3/25/2022 | ||
| 650 | 4 | |a Clinical Trial Protocol | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Research Support, N.I.H., Extramural | |
| 650 | 4 | |a Breast cancer | |
| 650 | 4 | |a Cancer survivorship | |
| 650 | 4 | |a Cognitive behavioral therapy | |
| 650 | 4 | |a Insomnia | |
| 650 | 4 | |a Voice-activated speaker | |
| 700 | 1 | |a Greenberg, Daniel |e verfasserin |4 aut | |
| 700 | 1 | |a Zhou, Eric |e verfasserin |4 aut | |
| 700 | 1 | |a Lewin, Daniel |e verfasserin |4 aut | |
| 700 | 1 | |a Morrow, Allison S |e verfasserin |4 aut | |
| 700 | 1 | |a Lieberman, Daniel |e verfasserin |4 aut | |
| 700 | 1 | |a Shaw, Callen |e verfasserin |4 aut | |
| 700 | 1 | |a Arem, Hannah |e verfasserin |4 aut | |
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