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| ID | Type | Description | Link |
|---|---|---|---|
| R21TR003522 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Pittsburgh | OTHER |
| National Center for Advancing Translational Sciences (NCATS) | NIH |
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The overall objective of this mixed-methods proposal is to answer the focused research question: What tailoring is necessary and sufficient to achieve optimal engagement with and efficacy of Sleep Healthy Using the Internet (SHUTi) for caregivers? The SHUTi program is a fully-automated Internet-delivered cognitive-behavioral therapy for insomnia (CBT-I) program. We will identify caregiving-related user- and environment characteristics that affect the use and impact of SHUTi, and other Internet interventions more broadly, for caregivers. We will recruit 100 high-intensity caregivers with insomnia to complete a baseline assessment of insomnia and caregiving context. Caregivers will then receive access to SHUTi in an open-label trial. At the end of the 9-week intervention period, caregivers will complete post-assessment and be categorized according to their level of engagement with the 6 SHUTi intervention lessons (or weekly "Cores"). We will test whether caregivers' engagement with SHUTi (i.e., being a non-user vs. incomplete user vs. complete user) is associated with their caregiving-related user characteristics (i.e., caregiving strain, self-efficacy, and guilt) and environment characteristics (i.e., proximity to care recipient; care recipient functional, cognitive, and behavioral status; caregiving tasks). Caregivers' barriers to and motivations for SHUTi engagement will be described from open-ended survey responses specific to participants' level of engagement as part of post-assessment. We will identify non-users' barriers to SHUTi adoption, the extent to which barriers were related to caregiving, and what modifications may have increased their motivation to try SHUTi. We will also identify users' (incomplete and complete) SHUTi usage barriers and motivations, the extent to which these were related to caregiving, and how tailoring may improve usage by increasing salience to caregivers. Thematic coding will also examine how caregivers' recommendations generalize to other evidence-based digital health interventions. Among caregivers using SHUTi, we will test whether the effects of SHUTi on cognitive mechanisms of change targeted by SHUTi (i.e., more adaptive sleep beliefs, internalized sleep locus of control) are associated with differences in caregiving-related user or environment characteristics.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHUTi (Sleep Healthy Using the Internet) | Experimental | Participants will be assigned to the SHUTi (Sleep Healthy Using the Internet) online intervention. They will spend 1-2 hours each week for 6-9 weeks completing daily sleep diaries as well as interactive core content covering topics of sleep behaviors, sleep thoughts, sleep education, and relapse prevention. As users progress through the intervention, they will receive automated, tailored instructions for how to improve their sleep. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHUTi (Sleep Healthy Using the Internet) | Behavioral | Cognitive Behavioral Therapy for insomnia delivered online and metered out over 6 weeks in a fully automated, interactive, tailored web-based program |
| Measure | Description | Time Frame |
|---|---|---|
| SHUTi Engagement | Level of SHUTi engagement: Core completion (i.e., nonuser [no cores completed], incomplete user [1-3 Cores], or complete user [4-6 Cores]) | 9-week Post-assessment |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep-related Cognitions | Dysfunctional Beliefs and Attitudes about Sleep; 16 items; sum scores range from 0 to 160 (higher scores indicate more dysfunctional attitudes and beliefs about sleep) | Baseline Pre-assessment and 9-week Post-assessment |
| Sleep Self-efficacy |
| Measure | Description | Time Frame |
|---|---|---|
| Open-ended Feedback on SHUTi | Non-users' post-assessment will include an open-ended survey regarding barriers to SHUTi adoption, the extent to which barriers were related to caregiving, and what modifications may have increased their motivation to try SHUTi. Users' (i.e., incomplete and complete) post-assessment will include an open-ended survey assessing SHUTi usage barriers and motivations, the extent to which these were related to caregiving, and how tailoring may improve usage by increasing salience to caregivers. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15260 | United States | ||
| University of Virginia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35019846 | Background | Shaffer KM, Ritterband LM, You W, Buysse DJ, Mattos MK, Camacho F, Glazer JV, Klinger J, Donovan H. Single-Group Trial of an Internet-Delivered Insomnia Intervention Among Higher-Intensity Family Caregivers: Rationale and Protocol for a Mixed Methods Study. JMIR Res Protoc. 2022 Jan 12;11(1):e34792. doi: 10.2196/34792. | |
| 38982942 | Result | Shaffer KM, Ritterband LM, You W, Mattos MK, Buysse DJ, Glazer JV, Klinger J, Donovan H. Caregivers' Internet-Delivered Insomnia Intervention Engagement and Benefit: SHUTi-CARE Trial Primary Quantitative Analysis. Ann Behav Med. 2024 Oct 16;58(10):645-657. doi: 10.1093/abm/kaae031. |
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| ID | Type | URL | Comment |
|---|---|---|---|
| Informed Consent Form | View IPD |
De-identified row-level data are available via data use agreement with the University of Virginia per institutional requirements; contact the primary investigator to initiate the contracting process.
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| ID | Title | Description |
|---|---|---|
| FG000 | SHUTi (Sleep Healthy Using the Internet) | Participants were assigned to the SHUTi (Sleep Healthy Using the Internet) online intervention. They spent 1-2 hours each week for 6-9 weeks completing daily sleep diaries as well as interactive core content covering topics of sleep behaviors, sleep thoughts, sleep education, and relapse prevention. As users progressed through the intervention, they received automated, tailored instructions for how to improve their sleep. SHUTi (Sleep Healthy Using the Internet): Cognitive Behavioral Therapy for insomnia delivered online and metered out over 6 weeks in a fully automated, interactive, tailored web-based program |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Results are only reported from the 100 participants who received access to the SHUTi intervention for the full intervention period, and are therefore counted towards the primary endpoint (i.e., level of engagement). One participant who completed baseline but withdrew during the intervention period is excluded.
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| ID | Title | Description |
|---|---|---|
| BG000 | SHUTi (Sleep Healthy Using the Internet) | Participants were assigned to the SHUTi (Sleep Healthy Using the Internet) online intervention. They spent 1-2 hours each week for 6-9 weeks completing daily sleep diaries as well as interactive core content covering topics of sleep behaviors, sleep thoughts, sleep education, and relapse prevention. As users progressed through the intervention, they received automated, tailored instructions for how to improve their sleep. SHUTi (Sleep Healthy Using the Internet): Cognitive Behavioral Therapy for insomnia delivered online and metered out over 6 weeks in a fully automated, interactive, tailored web-based program |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | SHUTi Engagement | Level of SHUTi engagement: Core completion (i.e., nonuser [no cores completed], incomplete user [1-3 Cores], or complete user [4-6 Cores]) | Posted | Count of Participants | Participants | 9-week Post-assessment |
|
9 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SHUTi (Sleep Healthy Using the Internet) | Participants were assigned to the SHUTi (Sleep Healthy Using the Internet) online intervention. They spent 1-2 hours each week for 6-9 weeks completing daily sleep diaries as well as interactive core content covering topics of sleep behaviors, sleep thoughts, sleep education, and relapse prevention. As users progressed through the intervention, they received automated, tailored instructions for how to improve their sleep. SHUTi (Sleep Healthy Using the Internet): Cognitive Behavioral Therapy for insomnia delivered online and metered out over 6 weeks in a fully automated, interactive, tailored web-based program |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kelly Shaffer | University of Virginia | 434-982-1022 | kshaffer@virginia.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 16, 2022 | Sep 6, 2024 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 16, 2022 | Apr 10, 2023 | ICF_001.pdf |
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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 |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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|
Sleep Locus of Control Scale with two subscales:
|
| Baseline Pre-assessment and 9-week Post-assessment |
| 9-week Post-assessment |
| SHUTi Evaluation | Items from the Internet Intervention Utility, Evaluation, and Adherence questionnaire assess users' perceived usability, acceptability, and perceived efficacy of SHUTi as well as barriers to program use | 9-week Post-assessment |
| Caregiving Strain | Pearlin Stress Scale - Overload subscale; 4 items; averaged scores range from 1 to 4 (higher scores indicate greater perceived burden) | Baseline Pre-assessment and 9-week Post-assessment |
| Insomnia Symptom Severity | Insomnia severity index; 2 items; summed scores range from 0 to 8 (higher scores indicate more severe insomnia symptoms) | Baseline Pre-assessment and 9-week Post-assessment |
| Sleep Onset Latency (SOL) | Data collected from sleep diary: Time fell asleep - Time attempting to fall asleep | Baseline Pre-assessment and 9-week Post-assessment |
| Wake After Sleep Onset (WASO) | Data collected from sleep diary: Total time awake between time feel asleep and final morning waking | Baseline Pre-assessment and 9-week Post-assessment |
| Perceived Sleep Quality | Data collected from sleep diary: Nightly rating of perceived sleep quality from very poor to very good | Baseline Pre-assessment and 9-week Post-assessment |
| Charlottesville |
| Virginia |
| 22903 |
| United States |
| 38990523 | Result | Shaffer KM, Perepezko K, Glazer JV, Mattos MK, Klinger J, Buysse DJ, Ritterband LM, Donovan H. Caregiver Experiences With an Internet-Delivered Insomnia Intervention: SHUTi-CARE Trial Primary Qualitative Analysis. Ann Behav Med. 2024 Oct 16;58(10):658-669. doi: 10.1093/abm/kaae041. |
| Analytic Code | View IPD |
| years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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|
|
| Secondary | Sleep-related Cognitions | Dysfunctional Beliefs and Attitudes about Sleep; 16 items; sum scores range from 0 to 160 (higher scores indicate more dysfunctional attitudes and beliefs about sleep) | SHUTi Non-Users did not complete this measure at post-assessment. There were 6 SHUTi Incomplete Users who did not complete the post-assessment. All SHUTi Complete Users completed post-assessment. | Posted | Mean | Standard Deviation | score on a scale | Baseline Pre-assessment and 9-week Post-assessment |
|
|
|
| Secondary | Sleep Self-efficacy | Sleep Locus of Control Scale with two subscales:
| SHUTi Non-Users did not complete this measure at post-assessment. There were 6 SHUTi Incomplete Users who did not complete the post-assessment. All SHUTi Complete Users completed post-assessment. | Posted | Mean | Standard Deviation | score on a scale | Baseline Pre-assessment and 9-week Post-assessment |
|
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| Other Pre-specified | Open-ended Feedback on SHUTi | Non-users' post-assessment will include an open-ended survey regarding barriers to SHUTi adoption, the extent to which barriers were related to caregiving, and what modifications may have increased their motivation to try SHUTi. Users' (i.e., incomplete and complete) post-assessment will include an open-ended survey assessing SHUTi usage barriers and motivations, the extent to which these were related to caregiving, and how tailoring may improve usage by increasing salience to caregivers. | Not Posted | 9-week Post-assessment | Participants |
| Other Pre-specified | SHUTi Evaluation | Items from the Internet Intervention Utility, Evaluation, and Adherence questionnaire assess users' perceived usability, acceptability, and perceived efficacy of SHUTi as well as barriers to program use | Not Posted | 9-week Post-assessment | Participants |
| Other Pre-specified | Caregiving Strain | Pearlin Stress Scale - Overload subscale; 4 items; averaged scores range from 1 to 4 (higher scores indicate greater perceived burden) | Not Posted | Baseline Pre-assessment and 9-week Post-assessment | Participants |
| Other Pre-specified | Insomnia Symptom Severity | Insomnia severity index; 2 items; summed scores range from 0 to 8 (higher scores indicate more severe insomnia symptoms) | Not Posted | Baseline Pre-assessment and 9-week Post-assessment | Participants |
| Other Pre-specified | Sleep Onset Latency (SOL) | Data collected from sleep diary: Time fell asleep - Time attempting to fall asleep | Not Posted | Baseline Pre-assessment and 9-week Post-assessment | Participants |
| Other Pre-specified | Wake After Sleep Onset (WASO) | Data collected from sleep diary: Total time awake between time feel asleep and final morning waking | Not Posted | Baseline Pre-assessment and 9-week Post-assessment | Participants |
| Other Pre-specified | Perceived Sleep Quality | Data collected from sleep diary: Nightly rating of perceived sleep quality from very poor to very good | Not Posted | Baseline Pre-assessment and 9-week Post-assessment | Participants |
| 0 |
| 100 |
| 0 |
| 100 |
| 0 |
| 100 |
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| D001523 |
| Mental Disorders |
| Post-Assessment |
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| Post-Assessment Sleep Locus of Control - Internal |
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| Baseline Sleep Locus of Control - External |
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| Post-Assessment Sleep Locus of Control - External |
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