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| Name | Class |
|---|---|
| University of Rochester | OTHER |
| Northeastern University | OTHER |
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Many Veterans of the recent wars in Iraq and Afghanistan struggle with chronic insomnia (trouble falling or staying asleep). Most current interventions for insomnia are time-consuming, making it difficult for this younger, working group of Veterans to use and benefit from these interventions. The investigators will assess whether Veterans find it helpful to use two health information technology tools, one for measuring participant sleep (the WatchPAT) and one for managing participant sleep (the CBTI Coach). The WatchPAT will measure physiological sleep in the Veteran participant's home. The CBTI Coach is a mobile health application used on the Veteran's mobile phone or tablet to teach skills that can reduce insomnia. The investigators will combine use of the WatchPAT with the CBTI Coach so Veterans can self-manage insomnia at home. Participants will record their physiological sleep and self-report on their sleep at home during a 6 week self-management program. The investigators will measure if Veterans find the tools helpful and easy to use, and which Veterans find the tools most helpful.
Sleep disturbance in the form of chronic insomnia (difficulty in falling or staying asleep) is a major health care problem for Operation Enduring Freedom (OEF), Operation Iraqi Freedom (OIF), and Operation New Dawn (OND) Veterans. Chronic insomnia is often co-morbid with mental and behavioral health issues such as posttraumatic stress disorder (PTSD) and mild traumatic brain injury (mTBI), which are common in these Veterans. Current behavioral interventions like cognitive behavioral therapy for insomnia (CBTI) that are used to treat chronic insomnia are effective, but time-consuming. As a result, this largely younger, working cohort of Veterans does not use and benefit from these interventions as much as they could. The investigators will assess the usability and feasibility of two health information technology (HIT) tools for measuring objective and subjective sleep, and for self-managing chronic insomnia. An existing mobile sleep monitoring device used by some VA sleep clinics, the WatchPAT, will be used to measure objective sleep parameters in the Veteran's home. A benefit of this tool is that it can detect probable sleep apnea, which will permit referral of these Veterans for sleep apnea treatment instead of insomnia self-management. An existing VA mobile health application (or app), the CBTI Coach, can be used on a mobile device to teach skills to reduce insomnia based on the elements of manualized CBTI. The goal is to combine the WatchPAT and the CBTI Coach along with self-management guidance to help Veterans with chronic insomnia learn how to improve their sleep. As part of a 6-week pre-post intervention pilot usability and feasibility trial, patients will record their objective and subjective sleep at home at the beginning of the 6-week self-management trial and again at the end. Subjective sleep reports in the form of sleep diaries will be measured throughout the program as part of using the CBTI Coach app. The objective and subjective sleep reports will be combined and accessible from the mobile device and can be used to help guide sleep self-management by the participant. Self-management will be aided by self-management worksheets and features of the CBTI Coach App. Usability of the two HIT tools will be assessed within the conceptual framework of an Integrated Technology Acceptance Model via survey items about each of the HIT tools. Feasibility will be assessed using measures of the number of times that elements of the CBTI Coach were accessed during the 6-week program, and from a semi-structured qualitative interview conducted at the end of the program. In the interview, the investigators will obtain information about the barriers to and facilitators of use of the WatchPAT and CBTI Coach. If there is high use of these tools for insomnia self-management, then the pilot study will have provided important incremental value to the new VA CBTI Coach app. The investigators also will collect data about the user factors that impact use of the tools (e.g., depression, mild traumatic brain injury, age), and thereby either be able to target the tools toward those most likely to use them, or suggest further developments to increase use by potential users. The pilot sample will provide preliminary data on sleep outcomes. The proposed work is responsive to multiple priority areas for HSR&D including Healthcare Informatics, Healthcare Access, Mental and Behavioral Health, and Post-deployment Health. By partnering with the VA Office of Connected Health (Web and Mobile Solutions), the VA's eHealth QUERI, and the developers of the VA CBTI Coach App, the investigators will ensure that these findings are maximally useful for future versions of the CBTI Coach app. The investigators also will be able to determine the usefulness of an integrated mobile sleep assessment and self-management program that can be used by Veterans anywhere.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| WatchPAT and CBT-i Coach mobile app | Experimental | Individuals use the WatchPAT sleep monitor and the CBT-i Coach app to self-manage insomnia |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WatchPAT sleep monitor | Device | Self-management of insomnia using a mobile sleep device |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Using WatchPAT | Use of WatchPAT on 3 nights. In Week 0 it is the number of participants who used the WatchPAT that Week (and participants had two possible nights during that week that they could use the WatchPAT). In Week 6 it is the number of participants who used the WatchPAT that Week (and participants had one night that they could use the WatchPAT). We measured participant adherence using a count of the number of participants who used the WatchPAT at Week 0, and the number of participants using the WatchPAT at Week 6. | Week 0 (Pre-Intervention) and Week 6 (Post-Intervention) |
| Number of Participants Using CBT-I Coach | CBT = Cognitive Behavioral Therapy. Use of CBT-I Coach sleep diaries in Week 0 and Week 6. We measured participant adherence by a count of the number of participants who used the CBT-I Coach at Week 0 (by our definition of use), and the number of participants using the CBT-I Coach at Week 6. Because of the small number of completers and because this is a feasibility study, we provide only descriptive data. | Week 0 (Pre-Intervention) and Week 6 (Post-Intervention) |
| Measure | Description | Time Frame |
|---|---|---|
| Insomnia Severity Index Score | Validated self-report measure of Insomnia Symptom Severity (ISI). The minimum ISI scale score is 0, the maximum scale score is 28, and higher scores indicate worse insomnia. Because of the small number of completers and because this is a feasibility study, we provide only descriptive data in the form of means (and standard deviation). | Week 0 (Pre-Intervention) and Week 4 (Mid-Intervention) and Week 6 (Post-Intervention) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karen S. Quigley, PhD | Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA | Bedford | Massachusetts | 01730 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36530383 | Derived | Kaitz J, Robinson SA, Petrakis BA, Reilly ED, Chamberlin ES, Wiener RS, Quigley KS. Veteran Acceptance of Sleep Health Information Technology: a Mixed-Method Study. J Technol Behav Sci. 2023;8(1):57-68. doi: 10.1007/s41347-022-00287-x. Epub 2022 Dec 13. | |
| 31342904 | Derived | Reilly ED, Robinson SA, Petrakis BA, Kuhn E, Pigeon WR, Wiener RS, McInnes DK, Quigley KS. Mobile App Use for Insomnia Self-Management: Pilot Findings on Sleep Outcomes in Veterans. Interact J Med Res. 2019 Jul 24;8(3):e12408. doi: 10.2196/12408. |
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| ID | Title | Description |
|---|---|---|
| FG000 | WatchPAT and CBT-i Coach App | Individuals use the WatchPAT sleep monitor and the CBT-i Coach app to self-manage insomnia WatchPAT sleep monitor: Self-management of insomnia using a mobile sleep device CBT-i Coach mobile app: Self-management of insomnia using a mobile app based on Cognitive Behavioral Therapy for Insomnia |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | WatchPAT and CBT-i Coach App | Individuals use the WatchPAT sleep monitor and the CBT-i Coach app to self-manage insomnia WatchPAT sleep monitor: Self-management of insomnia using a mobile sleep device CBT-i Coach mobile app: Self-management of insomnia using a mobile app based on Cognitive Behavioral Therapy for Insomnia |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Number of Participants Using WatchPAT | Use of WatchPAT on 3 nights. In Week 0 it is the number of participants who used the WatchPAT that Week (and participants had two possible nights during that week that they could use the WatchPAT). In Week 6 it is the number of participants who used the WatchPAT that Week (and participants had one night that they could use the WatchPAT). We measured participant adherence using a count of the number of participants who used the WatchPAT at Week 0, and the number of participants using the WatchPAT at Week 6. | Those who completed enrollment and were not withdrawn by study personnel for insomnia are those whose data are used for Week 0. | Posted | Count of Participants | Participants | Week 0 (Pre-Intervention) and Week 6 (Post-Intervention) |
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We monitored for adverse events only those participants who were eligible and received the intervention.
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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 | WatchPAT and CBT-i Coach App | Individuals use the WatchPAT sleep monitor and the CBT-i Coach app to self-manage insomnia WatchPAT sleep monitor: Self-management of insomnia using a mobile sleep device CBT-i Coach mobile app: Self-management of insomnia using a mobile app based on Cognitive Behavioral Therapy for Insomnia |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Karen S. Quigley | Edith Nourse Rogers Memorial VA Hospital | 781-687-2273 | karen.quigley@va.gov |
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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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| CBT-i Coach mobile app | Behavioral | Self-management of insomnia using a mobile app based on Cognitive Behavioral Therapy for Insomnia |
|
| Pittsburgh Sleep Quality Index (PSQI) Total Score | Validated self-report measure of self-reported sleep quality. The minimum PSQI Total scale score is 0, the maximum scale score is 21 and higher scale scores indicate worse subjective sleep quality. Because of the small number of completers and because this is a feasibility study, we provide only descriptive data in the form of means (and standard deviation). | Week 0 (Pre-Intervention) and Week 4 (Mid-Intervention) and Week 6 (Post-Intervention) |
| Functional Outcomes of Sleep Score | Validated self-report short-form (10 item) measure of Functional Outcomes of Sleep-10 (FOSQ-10). The minimum FOSQ score is 5, the maximum score is 20, and higher scores indicate better functioning. Because of the small number of completers and because this is a feasibility study, we provide only descriptive data in the form of means (and standard deviation). | Week 0 (Pre-Intervention) and Week 4 (Mid-Intervention) and Week 6 (Post-Intervention) |
| years |
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| Sex: Female, Male | 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 | Count of Participants | Participants |
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| Height | Mean | Standard Deviation | inches |
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| Weight | Mean | Standard Deviation | pounds |
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| Usability Satisfaction with Care | The minimum for this subscale score is 3. The maximum for this subscale score is 21. Higher scores indicate greater satisfaction with their medical care. These scores are from the Usability Survey which is given only at the baseline and used to predict later tech use. Also, because this predictor is measured at baseline to predict initiation of tech use, we can use the complete, enrolled sample of 38, even if individuals are withdrawn later for apnea. | Mean | Standard Deviation | units on a scale |
|
| Usability Health Knowledge | The minimum for this subscale score is 2. The maximum for this subscale score is 14. Higher scores indicate greater health knowledge. These scores are from the Usability Survey which is given only at the baseline and used to predict later tech use. Also, because this predictor is measured at baseline to predict initiation of tech use, we can use the complete, enrolled sample of 38, even if individuals are withdrawn later for apnea. | Mean | Standard Deviation | units on a scale |
|
| Usability Internet Dependence | The minimum for this subscale score is 4. The maximum for this subscale score is 28. Higher scores indicate greater internet dependence. These scores are from the Usability Survey which is given only at the baseline and used to predict later tech use. Also, because this predictor is measured at baseline to predict initiation of tech use, we can use the complete, enrolled sample of 38, even if individuals are withdrawn later for apnea. | Mean | Standard Deviation | units on a scale |
|
| Usability Information Seeking Preferences | The minimum for this subscale score is 4. The maximum for this subscale score is 28. Higher scores indicate greater preference for seeking information. These scores are from the Usability Survey which is given only at the baseline and used to predict later tech use. Also, because this predictor is measured at baseline to predict initiation of tech use, we can use the complete, enrolled sample of 38, even if individuals are withdrawn later for apnea. | Mean | Standard Deviation | units on a scale |
|
| Usability Healthcare Need | The minimum for this subscale score is 0. The maximum for this subscale score is 4. Higher scores indicate greater health care need. These scores are from the Usability Survey which is given only at the baseline and used to predict later tech use. Also, because this predictor is measured at baseline to predict initiation of tech use, we can use the complete, enrolled sample of 38, even if individuals are withdrawn later for apnea. | Mean | Standard Deviation | units on a scale |
|
| CBT-i Coach App Intrinsic Motivation | The minimum for this subscale score is 3. The maximum for this subscale score is 21. Higher scores indicate greater intrinsic motivation to use the CBT-i Coach app. These scores are from the Usability Survey which is given only at the baseline and used to predict later tech use. Also, because this predictor is measured at baseline to predict initiation of tech use, we can use the complete, enrolled sample of 38, even if individuals are withdrawn later for apnea. | Mean | Standard Deviation | units on a scale |
|
| CBT-i Coach Perceived Ease of Use | The minimum for this subscale score is 3. The maximum for this subscale score is 21. Higher scores indicate greater perceived ease of use of the CBT-i Coach app. These scores are from the Usability Survey which is given only at the baseline and used to predict later tech use. Also, because this predictor is measured at baseline to predict initiation of tech use, we can use the complete, enrolled sample of 38, even if individuals are withdrawn later for apnea. | Mean | Standard Deviation | units on a scale |
|
| CBT-i Coach Perceived Usefulness | The minimum for this subscale score is 3. The maximum for this subscale score is 21. Higher scores indicate greater perceived usefulness of the CBT-i Coach app. These scores are from the Usability Survey which is given only at the baseline and used to predict later tech use. Also, because this predictor is measured at baseline to predict initiation of tech use, we can use the complete, enrolled sample of 38, even if individuals are withdrawn later for apnea. | Mean | Standard Deviation | units on a scale |
|
| CBT-i Coach Behavioral Intention | The minimum for this subscale score is 2. The maximum for this subscale score is 14. Higher scores indicate greater behavioral intention to use the CBT-i Coach app. These scores are from the Usability Survey which is given only at the baseline and used to predict later tech use. Also, because this predictor is measured at baseline to predict initiation of tech use, we can use the complete, enrolled sample of 38, even if individuals are withdrawn later for apnea. | Mean | Standard Deviation | units on a scale |
|
| WatchPAT Intrinsic Motivation | The minimum for this subscale score is 3. The maximum for this subscale score is 21. Higher scores indicate greater intrinsic motivation to use the WatchPAT. These scores are from the Usability Survey which is given only at the baseline and used to predict later tech use. Also, because this predictor is measured at baseline to predict initiation of tech use, we can use the complete, enrolled sample of 38, even if individuals are withdrawn later for apnea. | Mean | Standard Deviation | units on a scale |
|
| WatchPAT Perceived Ease of Use | The minimum for this subscale score is 3. The maximum for this subscale score is 21. Higher scores indicate greater perceived ease of use of the WatchPAT. These scores are from the Usability Survey which is given only at the baseline and used to predict later tech use. Also, because this predictor is measured at baseline to predict initiation of tech use, we can use the complete, enrolled sample of 38, even if individuals are withdrawn later for apnea. | Mean | Standard Deviation | units on a scale |
|
| WatchPAT Perceived Usefulness | The minimum for this subscale score is 3. The maximum for this subscale score is 21. Higher scores indicate greater perceived usefulness of the WatchPAT. These scores are from the Usability Survey which is given only at the baseline and used to predict later tech use. Also, because this predictor is measured at baseline to predict initiation of tech use, we can use the complete, enrolled sample of 38, even if individuals are withdrawn later for apnea. | Mean | Standard Deviation | units on a scale |
|
| WatchPAT Behavioral Intention | The minimum for this subscale score is 2. The maximum for this subscale score is 14. Higher scores indicate greater behavioral intention to use the WatchPAT. These scores are from the Usability Survey which is given only at the baseline and used to predict later tech use. Also, because this predictor is measured at baseline to predict initiation of tech use, we can use the complete, enrolled sample of 38, even if individuals are withdrawn later for apnea. | Mean | Standard Deviation | units on a scale |
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| Primary | Number of Participants Using CBT-I Coach | CBT = Cognitive Behavioral Therapy. Use of CBT-I Coach sleep diaries in Week 0 and Week 6. We measured participant adherence by a count of the number of participants who used the CBT-I Coach at Week 0 (by our definition of use), and the number of participants using the CBT-I Coach at Week 6. Because of the small number of completers and because this is a feasibility study, we provide only descriptive data. | Those completing enrollment and not withdrawn by study personnel for insomnia were counted at Week 0. The Week 0 outcome measure is the number of participants who used sleep diaries in the CBT-I Coach for 5 or more nights of Week 0. In Week 6 it is the number of participants who used the CBT-I Coach for 5 or more nights during the sixth week. | Posted | Count of Participants | Participants | Week 0 (Pre-Intervention) and Week 6 (Post-Intervention) |
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| Secondary | Insomnia Severity Index Score | Validated self-report measure of Insomnia Symptom Severity (ISI). The minimum ISI scale score is 0, the maximum scale score is 28, and higher scores indicate worse insomnia. Because of the small number of completers and because this is a feasibility study, we provide only descriptive data in the form of means (and standard deviation). | Those who completed enrollment and were not withdrawn by study personnel for insomnia are considered those who are counted at Week 0. | Posted | Mean | Standard Deviation | units on a scale | Week 0 (Pre-Intervention) and Week 4 (Mid-Intervention) and Week 6 (Post-Intervention) |
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| Secondary | Pittsburgh Sleep Quality Index (PSQI) Total Score | Validated self-report measure of self-reported sleep quality. The minimum PSQI Total scale score is 0, the maximum scale score is 21 and higher scale scores indicate worse subjective sleep quality. Because of the small number of completers and because this is a feasibility study, we provide only descriptive data in the form of means (and standard deviation). | Those who completed enrollment and were not withdrawn by study personnel for insomnia are considered those who are counted at Week 0. | Posted | Mean | Standard Deviation | units on a scale | Week 0 (Pre-Intervention) and Week 4 (Mid-Intervention) and Week 6 (Post-Intervention) |
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| Secondary | Functional Outcomes of Sleep Score | Validated self-report short-form (10 item) measure of Functional Outcomes of Sleep-10 (FOSQ-10). The minimum FOSQ score is 5, the maximum score is 20, and higher scores indicate better functioning. Because of the small number of completers and because this is a feasibility study, we provide only descriptive data in the form of means (and standard deviation). | Those who completed enrollment and were not withdrawn by study personnel for insomnia are considered those who are counted at Week 0. | Posted | Mean | Standard Deviation | units on a scale | Week 0 (Pre-Intervention) and Week 4 (Mid-Intervention) and Week 6 (Post-Intervention) |
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| 0 |
| 38 |
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| 38 |
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| 38 |
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| D001523 |
| Mental Disorders |
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| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
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