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Completed

NCT Number: NCT03305354

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

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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Key information

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Edith Nourse Rogers Memorial VA Hospital

Bedford, Massachusetts, 01730, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

CBTI app intervention

Behavioral

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

physical activity intervention

Behavioral

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

Primary outcomes

  1. Insomnia Severity Index Total Score

    Time frame: 6 weeks (Immediate post-intervention)

    Total score on the Insomnia Severity Index

  2. Pittsburgh Sleep Quality Index Total Score

    Time frame: 6 weeks (Immediate post-intervention)

    Total score on the Pittsburgh Sleep Quality Index Total Score

Secondary outcomes

  1. Objective Sleep Efficiency

    Time frame: 6 weeks (Immediate post-intervention)

    Time spent in bed divided by time spent asleep as measured by the WatchPAT sleep monitor

  2. Daily step counts

    Time frame: 6 weeks (Immediate post-intervention)

    Daily step counts as measured by a Fitbit device

Other outcomes

  1. Functional Outcomes of Sleep

    Time frame: 6 weeks (Immediate post-intervention)

    Functional Outcomes of Sleep Questionnaire total score (10 item version)

  2. Social Engagement

    Time frame: 6 weeks (Immediate post-intervention)

    Total score on the Lubben Social Network Scale

  3. Community Engagement

    Time frame: 6 weeks (Immediate post-intervention)

    Total score on the Community Integration Questionnaire

  4. Physical Functional Health

    Time frame: 6 weeks (Immediate post-intervention)

    Physical Function score from the Veteran's RAND-12 scale

  5. Mental Functional Health

    Time frame: 6 weeks (Immediate post-intervention)

    Mental Function score from the Veteran's RAND-12 scale

Sponsors and collaborators

Lead sponsor

Northeastern University

Other

Collaborators

  • Edith Nourse Rogers Memorial Veterans Hospital

Registry information

Official study title

Mobile Intervention to Improve Functional Health and Community Engagement of Post-9/11 Veterans With Chronic Insomnia: Does Enhancing Physical Activity Help?

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 9, 2017
Registry last updated
Aug 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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