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Mobile Sleep Intervention for OEF, OIF and OND Veterans

Mobile Sleep and Pain Intervention for OEF, OIF and OND Veterans

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02392000
Enrollment
38
Registered
2015-03-18
Start date
2015-10-20
Completion date
2016-11-16
Last updated
2018-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Insomnia

Keywords

chronic insomnia, Veterans Health

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.

Interventions

DEVICEWatchPAT sleep monitor

Self-management of insomnia using a mobile sleep device

BEHAVIORALCBT-i Coach mobile app

Self-management of insomnia using a mobile app based on Cognitive Behavioral Therapy for Insomnia

Sponsors

University of Rochester
CollaboratorOTHER
Northeastern University
CollaboratorOTHER
VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants Using WatchPATWeek 0 (Pre-Intervention) and Week 6 (Post-Intervention)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.
Number of Participants Using CBT-I CoachWeek 0 (Pre-Intervention) and Week 6 (Post-Intervention)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.

Secondary

MeasureTime frameDescription
Insomnia Severity Index ScoreWeek 0 (Pre-Intervention) and Week 4 (Mid-Intervention) and Week 6 (Post-Intervention)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).
Pittsburgh Sleep Quality Index (PSQI) Total ScoreWeek 0 (Pre-Intervention) and Week 4 (Mid-Intervention) and Week 6 (Post-Intervention)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).
Functional Outcomes of Sleep ScoreWeek 0 (Pre-Intervention) and Week 4 (Mid-Intervention) and Week 6 (Post-Intervention)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).

Countries

United States

Participant flow

Participants by arm

ArmCount
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
38
Total38

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyGreater than mild sleep apnea exclusion18
Overall StudyLost to Follow-up8
Overall StudyWithdrawal by Subject1

Baseline characteristics

CharacteristicWatchPAT and CBT-i Coach App
Age, Continuous44.3 years
STANDARD_DEVIATION 10.9
CBT-i Coach App Intrinsic Motivation14.7 units on a scale
STANDARD_DEVIATION 3.2
CBT-i Coach Behavioral Intention12.5 units on a scale
STANDARD_DEVIATION 2.1
CBT-i Coach Perceived Ease of Use16.1 units on a scale
STANDARD_DEVIATION 2.9
CBT-i Coach Perceived Usefulness15.9 units on a scale
STANDARD_DEVIATION 3
Ethnicity (NIH/OMB)
Hispanic or Latino
5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
33 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
Height68.6 inches
STANDARD_DEVIATION 3.8
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
2 Participants
Race (NIH/OMB)
More than one race
3 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
2 Participants
Race (NIH/OMB)
White
31 Participants
Region of Enrollment
United States
38 Participants
Sex: Female, Male
Female
6 Participants
Sex: Female, Male
Male
32 Participants
Usability Healthcare Need1.3 units on a scale
STANDARD_DEVIATION 1
Usability Health Knowledge8.0 units on a scale
STANDARD_DEVIATION 2.4
Usability Information Seeking Preferences21.8 units on a scale
STANDARD_DEVIATION 4.4
Usability Internet Dependence19.5 units on a scale
STANDARD_DEVIATION 5.6
Usability Satisfaction with Care14.6 units on a scale
STANDARD_DEVIATION 3.1
WatchPAT Behavioral Intention12.6 units on a scale
STANDARD_DEVIATION 2.2
WatchPAT Intrinsic Motivation13.9 units on a scale
STANDARD_DEVIATION 3.8
WatchPAT Perceived Ease of Use16.7 units on a scale
STANDARD_DEVIATION 3.4
WatchPAT Perceived Usefulness16.3 units on a scale
STANDARD_DEVIATION 3.3
Weight195.9 pounds
STANDARD_DEVIATION 40.5

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 38
other
Total, other adverse events
0 / 38
serious
Total, serious adverse events
0 / 38

Outcome results

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.

Time frame: Week 0 (Pre-Intervention) and Week 6 (Post-Intervention)

Population: 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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
WatchPAT and CBT-i Coach Mobile AppNumber of Participants Using CBT-I CoachParticipants using CBT-I Coach at Baseline11 Participants
WatchPAT and CBT-i Coach Mobile AppNumber of Participants Using CBT-I CoachParticipants using CBT-I Coach Week 69 Participants
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.

Time frame: Week 0 (Pre-Intervention) and Week 6 (Post-Intervention)

Population: Those who completed enrollment and were not withdrawn by study personnel for insomnia are those whose data are used for Week 0.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
WatchPAT and CBT-i Coach Mobile AppNumber of Participants Using WatchPATNumber of Participants using WatchPAT at Baseline11 Participants
WatchPAT and CBT-i Coach Mobile AppNumber of Participants Using WatchPATNumber of Participants using WatchPAT at Week 611 Participants
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).

Time frame: Week 0 (Pre-Intervention) and Week 4 (Mid-Intervention) and Week 6 (Post-Intervention)

Population: Those who completed enrollment and were not withdrawn by study personnel for insomnia are considered those who are counted at Week 0.

ArmMeasureGroupValue (MEAN)Dispersion
WatchPAT and CBT-i Coach Mobile AppFunctional Outcomes of Sleep ScoreFOSQ Score at Baseline13.9 units on a scaleStandard Deviation 3.7
WatchPAT and CBT-i Coach Mobile AppFunctional Outcomes of Sleep ScoreFOSQ Score at Week 415.2 units on a scaleStandard Deviation 3.8
WatchPAT and CBT-i Coach Mobile AppFunctional Outcomes of Sleep ScoreFOSQ Score at Week 615.4 units on a scaleStandard Deviation 2.9
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).

Time frame: Week 0 (Pre-Intervention) and Week 4 (Mid-Intervention) and Week 6 (Post-Intervention)

Population: Those who completed enrollment and were not withdrawn by study personnel for insomnia are considered those who are counted at Week 0.

ArmMeasureGroupValue (MEAN)Dispersion
WatchPAT and CBT-i Coach Mobile AppInsomnia Severity Index ScoreInsomnia Severity Score at Baseline16.6 units on a scaleStandard Deviation 5.6
WatchPAT and CBT-i Coach Mobile AppInsomnia Severity Index ScoreInsomnia Severity Score at Week 412.4 units on a scaleStandard Deviation 4.5
WatchPAT and CBT-i Coach Mobile AppInsomnia Severity Index ScoreInsomnia Severity Score at Week 612.8 units on a scaleStandard Deviation 3.7
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).

Time frame: Week 0 (Pre-Intervention) and Week 4 (Mid-Intervention) and Week 6 (Post-Intervention)

Population: Those who completed enrollment and were not withdrawn by study personnel for insomnia are considered those who are counted at Week 0.

ArmMeasureGroupValue (MEAN)Dispersion
WatchPAT and CBT-i Coach Mobile AppPittsburgh Sleep Quality Index (PSQI) Total ScorePSQI Total Score at Week 610.7 units on a scaleStandard Deviation 3.3
WatchPAT and CBT-i Coach Mobile AppPittsburgh Sleep Quality Index (PSQI) Total ScorePSQI Total Score at Baseline12.8 units on a scaleStandard Deviation 4.6
WatchPAT and CBT-i Coach Mobile AppPittsburgh Sleep Quality Index (PSQI) Total ScorePSQI Total Score at Week 410.4 units on a scaleStandard Deviation 2.7

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026