Mobile Intervention to Improve Functional Health and Community Engagement of Post-9/11 Veterans With Chronic Insomnia
1 other identifier
interventional
33
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 4, 2017
CompletedFirst Posted
Study publicly available on registry
October 9, 2017
CompletedStudy Start
First participant enrolled
January 31, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 27, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 27, 2019
CompletedAugust 20, 2019
August 1, 2019
1.4 years
October 4, 2017
August 19, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Insomnia Severity Index Total Score
Total score on the Insomnia Severity Index
6 weeks (Immediate post-intervention)
Pittsburgh Sleep Quality Index Total Score
Total score on the Pittsburgh Sleep Quality Index Total Score
6 weeks (Immediate post-intervention)
Secondary Outcomes (2)
Objective Sleep Efficiency
6 weeks (Immediate post-intervention)
Daily step counts
6 weeks (Immediate post-intervention)
Other Outcomes (5)
Functional Outcomes of Sleep
6 weeks (Immediate post-intervention)
Social Engagement
6 weeks (Immediate post-intervention)
Community Engagement
6 weeks (Immediate post-intervention)
- +2 more other outcomes
Study Arms (2)
CBTI app intervention
EXPERIMENTALCognitive Behavioral Therapy for Insomnia delivered for 6 weeks via the CBT-I Coach app with use guided by a self-management guide
CBTI app+Physical Activity Intervention
ACTIVE COMPARATORCognitive 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
Interventions
Self-management guided use of a mobile app called the CBT-I Coach to teach sleep hygiene and enhance sleep
Self-management guided motivation to increase physical activity by increasing daily step counts
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Edith Nourse Rogers Memorial VA Hospital
Bedford, Massachusetts, 01730, United States
Related Publications (2)
Kaitz J, Robinson SA, Petrakis BA, Reilly ED, Chamberlin ES, Wiener RS, Quigley KS. Veteran Acceptance of Sleep Health Information Technology: a Mixed-Method Study. J Technol Behav Sci. 2023;8(1):57-68. doi: 10.1007/s41347-022-00287-x. Epub 2022 Dec 13.
PMID: 36530383DERIVEDReilly ED, Robinson SA, Petrakis BA, Gardner MM, Wiener RS, Castaneda-Sceppa C, Quigley KS. Mobile Intervention to Improve Sleep and Functional Health of Veterans With Insomnia: Randomized Controlled Trial. JMIR Form Res. 2021 Dec 9;5(12):e29573. doi: 10.2196/29573.
PMID: 34889746DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Karen S Quigley, PhD
Northeastern University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Associate Professor
Study Record Dates
First Submitted
October 4, 2017
First Posted
October 9, 2017
Study Start
January 31, 2018
Primary Completion
June 27, 2019
Study Completion
June 27, 2019
Last Updated
August 20, 2019
Record last verified: 2019-08
Data Sharing
- IPD Sharing
- Will not share