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

Chronic Insomnia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03305354
• Other study ID #: 17-09-10
• Status: Completed
• Phase: N/A
• Start date: January 31, 2018
• Est. completion date: June 27, 2019

Study information

• Verified date: August 2019
• Source: Northeastern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: June 27, 2019
• Est. primary completion date: June 27, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Chronic Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Behavioral:
• CBTI app intervention
Self-management guided use of a mobile app called the CBT-I Coach to teach sleep hygiene and enhance sleep
• Physical Activity intervention
Self-management guided motivation to increase physical activity by increasing daily step counts

Locations

Country	Name	City	State
United States	Edith Nourse Rogers Memorial VA Hospital	Bedford	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Northeastern University	Edith Nourse Rogers Memorial Veterans Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Functional Outcomes of Sleep	Functional Outcomes of Sleep Questionnaire total score (10 item version)	6 weeks (Immediate post-intervention)
Other	Social Engagement	Total score on the Lubben Social Network Scale	6 weeks (Immediate post-intervention)
Other	Community Engagement	Total score on the Community Integration Questionnaire	6 weeks (Immediate post-intervention)
Other	Physical Functional Health	Physical Function score from the Veteran's RAND-12 scale	6 weeks (Immediate post-intervention)
Other	Mental Functional Health	Mental Function score from the Veteran's RAND-12 scale	6 weeks (Immediate post-intervention)
Primary	Insomnia Severity Index Total Score	Total score on the Insomnia Severity Index	6 weeks (Immediate post-intervention)
Primary	Pittsburgh Sleep Quality Index Total Score	Total score on the Pittsburgh Sleep Quality Index Total Score	6 weeks (Immediate post-intervention)
Secondary	Objective Sleep Efficiency	Time spent in bed divided by time spent asleep as measured by the WatchPAT sleep monitor	6 weeks (Immediate post-intervention)
Secondary	Daily step counts	Daily step counts as measured by a Fitbit device	6 weeks (Immediate post-intervention)