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

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Insomnia
• Intervention / Treatment: Behavioral: CBTI app intervention; Behavioral: Physical Activity intervention

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Bedford, Massachusetts, United States, 01730
      • Edith Nourse Rogers Memorial VA Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Behavioral: CBTI app intervention; Self-management guided use of a mobile app called the CBT-I Coach to teach sleep hygiene and enhance sleep
Active Comparator: 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	Behavioral: CBTI app intervention; Self-management guided use of a mobile app called the CBT-I Coach to teach sleep hygiene and enhance sleep; Behavioral: Physical Activity intervention; Self-management guided motivation to increase physical activity by increasing daily step counts

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Sleep Efficiency	Time spent in bed divided by time spent asleep as measured by the WatchPAT sleep monitor	6 weeks (Immediate post-intervention)
Daily step counts	Daily step counts as measured by a Fitbit device	6 weeks (Immediate post-intervention)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional Outcomes of Sleep	Functional Outcomes of Sleep Questionnaire total score (10 item version)	6 weeks (Immediate post-intervention)
Social Engagement	Total score on the Lubben Social Network Scale	6 weeks (Immediate post-intervention)
Community Engagement	Total score on the Community Integration Questionnaire	6 weeks (Immediate post-intervention)
Physical Functional Health	Physical Function score from the Veteran's RAND-12 scale	6 weeks (Immediate post-intervention)
Mental Functional Health	Mental Function score from the Veteran's RAND-12 scale	6 weeks (Immediate post-intervention)

Collaborators and Investigators

• Sponsor: Northeastern University
• Collaborators: Edith Nourse Rogers Memorial Veterans Hospital
• Investigators: Principal Investigator: Karen S Quigley, PhD, Northeastern University

Publications and helpful links

General Publications

• Reilly 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2018
• Primary Completion (Actual): June 27, 2019
• Study Completion (Actual): June 27, 2019

Study Registration Dates

• First Submitted: October 4, 2017
• First Submitted That Met QC Criteria: October 4, 2017
• First Posted (Actual): October 9, 2017

Study Record Updates

• Last Update Posted (Actual): August 20, 2019
• Last Update Submitted That Met QC Criteria: August 19, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: physical activity; mobile health
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: 17-09-10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No