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| Name | Class |
|---|---|
| Edith Nourse Rogers Memorial Veterans Hospital | FED |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CBTI app intervention | Experimental | Cognitive 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 Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CBTI app intervention | Behavioral | Self-management guided use of a mobile app called the CBT-I Coach to teach sleep hygiene and enhance sleep |
|
| 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) |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karen S Quigley, PhD | Northeastern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Edith Nourse Rogers Memorial VA Hospital | Bedford | Massachusetts | 01730 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36530383 | Derived | 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. | |
| 34889746 | Derived | 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. |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| Physical Activity intervention | Behavioral | Self-management guided motivation to increase physical activity by increasing daily step counts |
|
| 6 weeks (Immediate post-intervention) |
| 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) |
| D001523 |
| Mental Disorders |
| D001519 | Behavior |