An interventional study of WatchPAT sleep monitor and CBT-i Coach mobile app in Chronic Insomnia, sponsored by VA Office of Research and Development. Completed at 1 site in United States. Open to participants aged 21 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-04-20.
Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Treatment
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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Exclusion Criteria:
Individuals use the WatchPAT sleep monitor and the CBT-i Coach app to self-manage insomnia
Device: WatchPAT sleep monitor · Behavioral: CBT-i Coach mobile app
Self-management of insomnia using a mobile sleep device
Self-management of insomnia using a mobile app based on Cognitive Behavioral Therapy for Insomnia
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.
Time frame: 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.
Time frame: Week 0 (Pre-Intervention) and Week 6 (Post-Intervention)
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).
Time frame: Week 0 (Pre-Intervention) and Week 4 (Mid-Intervention) and Week 6 (Post-Intervention)
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).
Time frame: 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).
Time frame: Week 0 (Pre-Intervention) and Week 4 (Mid-Intervention) and Week 6 (Post-Intervention)
| Milestone | WatchPAT and CBT-i Coach App |
|---|---|
| Started | 38 |
| Completed | 11 |
| Not completed | 27 |
| Withdrew: Greater than mild sleep apnea exclusion | 18 |
| Withdrew: Withdrawal by subject | 1 |
| Withdrew: Lost to follow-up | 8 |
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.
| Participants | WatchPAT and CBT-i Coach Mobile App |
|---|---|
| Number of Participants using WatchPAT at Baseline | 11 |
| Number of Participants using WatchPAT at Week 6 | 11 |
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.
| Participants | WatchPAT and CBT-i Coach App |
|---|---|
| Participants using CBT-I Coach at Baseline | 11 |
| Participants using CBT-I Coach Week 6 | 9 |
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).
| units on a scale | WatchPAT and CBT-i Coach App |
|---|---|
| Insomnia Severity Score at Baseline | 16.6 ± 5.6 |
| Insomnia Severity Score at Week 4 | 12.4 ± 4.5 |
| Insomnia Severity Score at Week 6 | 12.8 ± 3.7 |
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).
| units on a scale | WatchPAT and CBT-i Coach App |
|---|---|
| PSQI Total Score at Baseline | 12.8 ± 4.6 |
| PSQI Total Score at Week 4 | 10.4 ± 2.7 |
| PSQI Total Score at Week 6 | 10.7 ± 3.3 |
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).
| units on a scale | WatchPAT and CBT-i Coach App |
|---|---|
| FOSQ Score at Baseline | 13.9 ± 3.7 |
| FOSQ Score at Week 4 | 15.2 ± 3.8 |
| FOSQ Score at Week 6 | 15.4 ± 2.9 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| WatchPAT and CBT-i Coach App | 0/38 (0%) | 0/38 (0%) | 0/38 (0%) |
| Age, Continuous(years) | WatchPAT and CBT-i Coach App |
|---|---|
| Mean | 44.3 ± 10.9 |
| Sex: Female, Male(Participants) | WatchPAT and CBT-i Coach App |
|---|---|
| Female | 6 |
| Male | 32 |
| Ethnicity (NIH/OMB)(Participants) | WatchPAT and CBT-i Coach App |
|---|---|
| Hispanic or Latino | 5 |
| Not Hispanic or Latino | 33 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | WatchPAT and CBT-i Coach App |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 2 |
| White | 31 |
| More than one race | 3 |
| Unknown or Not Reported | 2 |
| Region of Enrollment(Participants) | WatchPAT and CBT-i Coach App |
|---|---|
| United States | 38 |
| Height(inches) | WatchPAT and CBT-i Coach App |
|---|---|
| Mean | 68.6 ± 3.8 |
| Weight(pounds) | WatchPAT and CBT-i Coach App |
|---|---|
| Mean | 195.9 ± 40.5 |
| Usability Satisfaction with Care(units on a scale) | WatchPAT and CBT-i Coach App |
|---|---|
| Mean | 14.6 ± 3.1 |
12 further baseline measures are reported on the registry.
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