Edith Nourse Rogers Memorial VA Hospital
Bedford, Massachusetts, 01730, United States
NCT Number: NCT03305354
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.
Looking for future studies?
Notify Me21 year–65 year
All sexes
Interventional
Not applicable
Bedford, Massachusetts, 01730, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: 6 weeks (Immediate post-intervention)
Total score on the Insomnia Severity Index
Time frame: 6 weeks (Immediate post-intervention)
Total score on the Pittsburgh Sleep Quality Index Total Score
Time frame: 6 weeks (Immediate post-intervention)
Time spent in bed divided by time spent asleep as measured by the WatchPAT sleep monitor
Time frame: 6 weeks (Immediate post-intervention)
Daily step counts as measured by a Fitbit device
Time frame: 6 weeks (Immediate post-intervention)
Functional Outcomes of Sleep Questionnaire total score (10 item version)
Time frame: 6 weeks (Immediate post-intervention)
Total score on the Lubben Social Network Scale
Time frame: 6 weeks (Immediate post-intervention)
Total score on the Community Integration Questionnaire
Time frame: 6 weeks (Immediate post-intervention)
Physical Function score from the Veteran's RAND-12 scale
Time frame: 6 weeks (Immediate post-intervention)
Mental Function score from the Veteran's RAND-12 scale
Northeastern University
Other
Mobile Intervention to Improve Functional Health and Community Engagement of Post-9/11 Veterans With Chronic Insomnia: Does Enhancing Physical Activity Help?
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.
Published trials that share one or more normalized conditions with this study.
NCT05482646
Behavior, Behavioral Symptoms
Hong Kong
View Trial DetailsNCT03160404
Behavior, Chronic Insomnia
Jatai, Goiás, Brazil
View Trial DetailsNCT03171519
Behavior, Chronic Insomnia
Jatai, Goiás, Brazil
View Trial DetailsNCT04471168
Chronic Insomnia, Dyssomnias
Issy-les-Moulineaux, Hauts de Seine, France
View Trial Details