Clinical trial NCT02392000: Mobile Sleep Intervention for OEF, OIF and OND Veterans
Official title: Mobile Sleep and Pain Intervention for OEF, OIF and OND Veterans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Insomnia
Keywords: chronic insomnia
Veterans Health
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: University of Rochester
name: Northeastern University
First posted: 2015-03-18
Enrollment: 38
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Participants must have served in the most recent wars in Iraq or Afghanistan (OIF, OEF or OND),
* be age 21-65,
* report current insomnia as defined by an Insomnia Index Severity 40 score \> 10 5,79,
* and report insomnia duration of at least 1 month and impaired daytime functioning (as measured by endorsing Much or Very Much on ISI Item 7 about how much sleep problems interfere with daily functioning).
* In addition, eligible individuals must be willing to use a device provided by the study team (an iPod touch).

Exclusion Criteria:

* Exclusions will include self-reported (or in-study determined) sleep apnea that is more than mild,
* periodic leg movements,
* or circadian rhythm disorder (delayed or advanced sleep phase).
* Exclusions for WatchPAT use include use of alpha blockers or short-acting nitrates,
* permanent pacemaker, or
* sustained non-sinus cardiac arrhythmias. Sleep apnea will be assessed from the WatchPAT on the first night of objective sleep testing and participants excluded from further participation if apnea is documented.
* Other exclusions include moderate to severe cognitive impairment defined by scores on the Telephone Mini Mental State Exam,
* inability to speak and read English,
* or malformation of the fingers that would preclude use of the WatchPAT device.
* In addition, individuals meeting criteria for current active psychosis, mania, suicidal ideation with plan and intent, or excessive alcohol use as determined using the AUDIT-C will be excluded from participation.
* Those with greater than mild sleep apnea as determined based on a WatchPAT-based Apnea-Hypopnea Index \[AHI\] \> 15/hour of sleep, will be withdrawn from the study and referred for sleep apnea treatment.

Primary outcomes:
measure: Number of Participants Using WatchPAT
timeFrame: Week 0 (Pre-Intervention) and Week 6 (Post-Intervention)
measure: Number of Participants Using CBT-I Coach
timeFrame: Week 0 (Pre-Intervention) and Week 6 (Post-Intervention)
Secondary outcomes:
measure: Insomnia Severity Index Score
timeFrame: Week 0 (Pre-Intervention) and Week 4 (Mid-Intervention) and Week 6 (Post-Intervention)
measure: Pittsburgh Sleep Quality Index (PSQI) Total Score
timeFrame: Week 0 (Pre-Intervention) and Week 4 (Mid-Intervention) and Week 6 (Post-Intervention)
measure: Functional Outcomes of Sleep Score
timeFrame: Week 0 (Pre-Intervention) and Week 4 (Mid-Intervention) and Week 6 (Post-Intervention)
Other outcomes:
Locations:
city: Bedford
country: United States
facility: Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA
state: Massachusetts
Study officials:
affiliation: Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA
name: Karen S. Quigley, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.