Mobile Intervention to Improve Functional Health and Community Engagement of Post-9/11 Veterans With Chronic Insomnia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-31

Study Completion Date

2019-06-27

Brief Summary

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Veterans of the most recent wars in Afghanistan and Iraq (collectively, post 9/11 Veterans) have notable sleep problems including chronic insomnia. Here, the investigators plan to compare two groups of veterans with insomnia: (1) one group that completes a 6 week self-management-guided use of a mobile app based on cognitive behavioral therapy for insomnia (CBTI alone) and (2) one group that completes a 6 week combined self-management-guided use of the mobile CBTI app in addition to a physical activity (PA) intervention (CBTI + PA). The investigators hypothesize that the group receiving the adjunctive 6-week PA intervention will have better subjective and objective sleep, higher step counts, and better functional health and social and community integration than those receiving CBTI alone. This pilot work will provide evidence to guide the design of a future randomized controlled trial.

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Detailed Description

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To determine if the addition of physical activity (PA) to (CBTI) can further enhance sleep, physical activity, functioning, or social engagement over and above self-management use of a CBTI app alone, the investigators will randomly assign post-9/11 veteran participants with chronic, functionally impairing insomnia to either (1) a self-management-based use of an app based on cognitive behavioral therapy for insomnia (CBTI; CBTI alone arm) or to (2) a self-management-based use of the CBTI app + a physical activity (PA) intervention (CBTI + PA) that includes PA monitoring (via a Fitbit device) with individualized goal-setting to encourage increased daily steps across the 6 weeks. For the PA goal, the investigators will attempt to get all participants to at least the typical 10,000 daily steps goal cited as a strong predictor of positive health outcomes (Choi, Pak, \& Choi, 2007). The investigators will tailor the step goals based on the person's initial level of daily steps, and increment step goals weekly to maximize motivation and enhance the likelihood that the participant can meet the goal.

Conditions

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Chronic Insomnia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CBTI app intervention

Cognitive Behavioral Therapy for Insomnia delivered for 6 weeks via the CBT-I Coach app with use guided by a self-management guide

Group Type EXPERIMENTAL

CBTI app intervention

Intervention Type BEHAVIORAL

Self-management guided use of a mobile app called the CBT-I Coach to teach sleep hygiene and enhance sleep

CBTI app+Physical Activity Intervention

Cognitive Behavioral Therapy for Insomnia delivered for 6 weeks via the CBT-I Coach app with use guided by a self-management guide plus self-management guidance on increased step counts

Group Type ACTIVE_COMPARATOR

CBTI app intervention

Intervention Type BEHAVIORAL

Self-management guided use of a mobile app called the CBT-I Coach to teach sleep hygiene and enhance sleep

Physical Activity intervention

Intervention Type BEHAVIORAL

Self-management guided motivation to increase physical activity by increasing daily step counts

Interventions

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CBTI app intervention

Self-management guided use of a mobile app called the CBT-I Coach to teach sleep hygiene and enhance sleep

Intervention Type BEHAVIORAL

Physical Activity intervention

Self-management guided motivation to increase physical activity by increasing daily step counts

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Eligible individuals will be US military Veterans
* Eligible veterans will have served in the military during the post-9/11 period
* Eligible veterans will have chronic, functionally impairing insomnia (i.e., at baseline veterans must have an Insomnia Severity Index score \> 10 with insomnia duration of at least 1 month, and impaired daytime functioning.
* Eligible individuals must be willing to use devices (e.g., Fitbit, WatchPAT)provided by the study team.
* Eligible individuals may have mild or moderate obstructive sleep apnea (as determined by one out of either of two nights with a WatchPAT-based Apnea-Hypopnea Index \[AHI\] \<= 30 events/hour of sleep).

Exclusion Criteria

* Periodic leg movements
* Circadian rhythm disorder
* Use of medications or health issues (e.g., permanent pacemaker, sustained non-sinus cardiac arrhythmias, finger deformity, etc.) that would interfere with the use of the WatchPAT sleep monitor
* Severe obstructive sleep apnea (as determined by one out of either of two nights with a WatchPAT-based Apnea-Hypopnea Index \[AHI\] \> 30 events/hour of sleep)

Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No