Chronic Insomnia
Conditions
Keywords
mobile health, physical activity
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.
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.
Interventions
BEHAVIORALCBTI app intervention
Self-management guided use of a mobile app called the CBT-I Coach to teach sleep hygiene and enhance sleep
BEHAVIORALPhysical Activity intervention
Self-management guided motivation to increase physical activity by increasing daily step counts
Sponsors
Edith Nourse Rogers Memorial Veterans Hospital
Northeastern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Insomnia Severity Index Total Score | 6 weeks (Immediate post-intervention) | Total score on the Insomnia Severity Index |
| Pittsburgh Sleep Quality Index Total Score | 6 weeks (Immediate post-intervention) | Total score on the Pittsburgh Sleep Quality Index Total Score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective Sleep Efficiency | 6 weeks (Immediate post-intervention) | Time spent in bed divided by time spent asleep as measured by the WatchPAT sleep monitor |
| Daily step counts | 6 weeks (Immediate post-intervention) | Daily step counts as measured by a Fitbit device |
Other
| Measure | Time frame | Description |
|---|---|---|
| Functional Outcomes of Sleep | 6 weeks (Immediate post-intervention) | Functional Outcomes of Sleep Questionnaire total score (10 item version) |
| Mental Functional Health | 6 weeks (Immediate post-intervention) | Mental Function score from the Veteran's RAND-12 scale |
| Social Engagement | 6 weeks (Immediate post-intervention) | Total score on the Lubben Social Network Scale |
| Community Engagement | 6 weeks (Immediate post-intervention) | Total score on the Community Integration Questionnaire |
| Physical Functional Health | 6 weeks (Immediate post-intervention) | Physical Function score from the Veteran's RAND-12 scale |
Countries
United States
Outcome results
None listed