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PPO 14-144 – HSR&D Study

PPO 14-144
Mobile Sleep and Pain Intervention for OEF, OIF and OND Veterans
Karen S. Quigley PhD
VA Bedford HealthCare System, Bedford, MA
Bedford, MA
Funding Period: April 2015 - March 2016

Chronic insomnia (difficulty falling or staying asleep) is a major health 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 (Cubed) 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. We will assess the usability and feasibility of health information technology (HIT) tools for measuring objective and subjective sleep, and for self-managing chronic insomnia. An existing mobile sleep monitoring device, 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 for sleep apnea treatment instead of insomnia self-management. An existing VA mobile health application (or app), the CBT-i Coach, will be used on a mobile device to enhance skills for reducing and coping with insomnia based on elements of manualized CBTI. Our goal is to combine use of the WatchPAT and the CBT-i Coach along with self-management guidance to help Veterans with chronic insomnia learn 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 as part of using the CBT-i Coach app. The objective and subjective sleep reports will be accessible on the mobile device and can be used to help guide sleep self-management by the patient.

For the pilot trial we will assess the usability of health information technologies (HITs), a device for home-based objective sleep monitoring, the WatchPAT, a self-management tool, and the VA's CBT-i Coach mobile health application (app). This pilot study will address the following aims in OEF, OIF, and OND veterans with chronic insomnia: (1) Determine usability and feasibility of the integrated assessment and app-based self-management intervention for chronic insomnia in Veterans using a pre-post treatment design; (2) Determine Veteran traits or features that influence usability and feasibility; (3) Explore measures of objective and subjective sleep quality for use in determining statistical power for a larger future trial of the integrated use of the WatchPAT and self-management scaffolding for the CBT-i Coach to self-manage insomnia.

The pilot trial will use a pre-post design to assess usability of the HITs and feasibility of the tools for self-management of chronic insomnia. Self-management will occur in the patient's home with in-person or telephone assessments at baseline, mid-intervention (3 weeks) and post-intervention (6 weeks). Forty OEF, OIF, OND participants with chronic insomnia will be enrolled. Those with sleep apnea (as determined by the WatchPAT) will be referred for care outside the study and will not continue participation. Measures will include objective sleep outcomes (e.g., total sleep time, sleep efficiency), subjective sleep measures (e.g., Insomnia Severity Index), other health measures (e.g., depressive symptoms), HIT usability (e.g., perceived usefulness of the HIT tools), and functional health measures (e.g., Functional Outcomes of Sleep).

Data collection was completed in September, 2016 and final study enrollment was N=38. Greater than mild apnea (apnea-hypopnea index of >15/hour) led to removal from the study and referral for further evaluation or management of possible sleep apnea, where clinically indicated. Of the 38 enrolled, there were N=11 completers, N=18 who were withdrawn due to screening positive for moderate or severe sleep apnea, and N=9 who withdrew from the study because they did not want to continue. Thus, a home sleep monitoring device-based positive screen for moderate or severe sleep apnea, occurred in 47.4% of the sample.

In the full sample, there were 32 males/6 females, the sample was predominantly European American (89.5%), and 13% indicated they were of Hispanic ethnicity. The sample was well-educated with 60.5% having an Associate's or higher degree, and 55% were married, 29% single/never married, and 16% either separated or divorced. The sample mean BMI was 29 (i.e., in the overweight range).

We addressed the following a priori hypotheses based on our conceptual model of HIT use.
1. Perceived ease of use and perceived usefulness both will be positively correlated with
behavioral intention and actual use.
2. Higher behavioral intention to use the app will correlate positively with actual use.
3. Demographic and health factors such as older age or presence of mTBI will reduce actual use.
Internal reliability was good for all self-report scales including all the sub-scales of the Usability Survey (all alphas > 0.7). Results indicated that there were no measured antecedent factors that themselves correlated significantly with intrinsic motivation to use either the CBTi Coach or WatchPAT (WP) sleep device (all ps >.1). This was not consistent with a priori predictions based on our Integrated Technology Acceptance Model. However, as predicted by this model and consistent with Hypothesis 1, there were significant positive correlations between intrinsic motivation and perceived ease of use (App: r = .67, p < .001; WP: r = .51, p < .01), perceived usefulness (App: r = .57, p < .001; WP: r = .53, p < .01) and behavioral intention to use (App: r = .40, p < .001; WP: r = .36, p < .05) for both the CBTi Coach App and the WatchPAT device. Also consistent with Hypothesis 1, when we regressed intrinsic motivation, perceived ease of use, and perceived usefulness of the CBT-i Coach app on behavioral intention to use it, the overall model was significant (R2 = .53, F(3, 34) = 12.87, p < .001), and both perceived ease of use ( = .58, t(37) = 3.32, p < .001) and perceived usefulness ( = .38, t(37) = 2.46, p < .05) were significant predictors of intent to use the CBTi Coach app, with increases in both resulting in greater reported intent to use the CBTi Coach app. However, baseline intrinsic motivation to use the CBTi Coach app was not a significant predictor of intent to use the CBTi Coach app ( = -.22, t(37) = -1,28 p =.21). Similarly for the WatchPAT device, the overall regression model was significant (R2 = .54, F(3, 34) = 13.53, p < .001), and both perceived ease of use ( = .44, t(37) = 2.75, p < .05) and perceived usefulness ( = .42, t(37) = 2.58, p < .05) were significant predictors of intent to use the WatchPAT, with increases in both resulting in greater reported intent to use WatchPAT. As with the CBT-I Coach app, baseline intrinsic motivation to use the WatchPAT was not a significant predictor of intent to use WatchPAT ( = -.09, t(37) = -0.64, p = .53). Our results were not consistent with Hypothesis 2. To assess this hypothesis, we used those in the sample (N=20) who were not withdrawn due to apnea and conducted a logistic regression to ascertain the effect of the intrinsic motivation, perceived ease of use, perceived usefulness, and behavioral intention to use the CBTi Coach App on the likelihood that participants would complete the study. The logistic regression model was not statistically significant, 2(8) = 2.68, p = .95. None of the individual predictors significantly predicted completer status: intrinsic motivation (p = .63), perceived ease of use (p = .52), perceived usefulness (p = .28), and behavioral intention (p = .65). The results for the WatchPAT data also did not support Hypothesis 2. With respect to Hypothesis 3, none of the self-reported health variables (e.g., PTSD symptoms, depressive symptoms, pain interference, etc.) or age significantly predicted actual use of a major feature of the CBTi Coach app, namely use of daily sleep diaries.

Firstly, we found a high prevalence of sleep apnea in this largely middle-aged, male sample both compared with epidemiological community samples (5% estimate from a review by Young, Peppard & Gottlieb, 2002) and somewhat higher than a Veteran sample where 35/91 or 38.5% screened positive for self-reported sleep apnea symptoms (in an intervention study by Ulmer, Edinger & Calhoun, 2011). Veteran administrative data sources (VHA beneficiaries) from before the post-9/11 era revealed a much lower prevalence of diagnosed sleep apnea in the VA medical record (about 3.5%; Sharafkhaneh, et al., 2004; 2005). Thus, our prevalence rate for sleep apnea is considerably higher than expected, although the sample is small and thus, the rate may not be reliable. This study has the advantage that apnea was detected via a device for home sleep monitoring rather than via self-reported sleep apnea symptoms as in some prior studies. Secondly, we found good usability of the CBTi Coach app and WatchPAT in this sample, and determined that feasibility was reasonable with more than half of those who were not excluded due to apnea completing all assessments. Further, exploratory analyses on completers revealed significant differences (t(10) = 4.14, p < .01) between baseline Insomnia Severity Index scores (M = 16.63, SD =5.55) and post-intervention follow-up scores (M = 12.82, SD = 3.74) such that self-reported insomnia (ISI) decreased over time in completers. In addition, Pittsburgh Sleep Quality scores also increased significantly (t(10) = -3.07, p < .05) and functional outcomes of sleep scores improved (t(10) = -3.07, p < .05) from pre- to post-intervention in completers.

External Links for this Project

NIH Reporter

Grant Number: I21HX001616-01A1

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Conference Presentations

  1. Quigley KS. Feasibility pilot of mobile health tools for insomnia self-management. Paper presented at: VA Boston Healthcare System Mental Health Grand Rounds; 2016 Feb 24; Brockton, MA. [view]
  2. Quigley KS. Mobile tools for enhancing sleep in post-9/11 Veterans. Paper presented at: Psychiatric Rehabilitation Association Recovery Workforce Summit; 2016 May 25; Boston, MA. [view]

DRA: Other Conditions, Mental, Cognitive and Behavioral Disorders, Brain and Spinal Cord Injuries and Disorders
DRE: Treatment - Implementation, Treatment - Efficacy/Effectiveness Clinical Trial
Keywords: none
MeSH Terms: none

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