Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2025-12-24 @ 10:52 PM
NCT ID:
NCT07083869
Brief Summary:
The objective of this randomized controlled trial of the Insomnia Coach mobile app is to evaluate the potential effects of app use on reducing insomnia symptoms among Veterans with significant insomnia and PTSD symptoms. It is also intended to evaluate the impact of the app on other outcomes, including PTSD, depression, and anxiety symptoms, and psychosocial functioning. Finally, the study is designed to assess perceptions of Insomnia Coach regarding its perceived helpfulness, satisfaction, and likes/dislikes to inform its continued improvement. The results of this study will inform the next steps of research evaluating Insomnia Coach with Veterans with significant insomnia and PTSD symptoms, namely a larger-scale, VA ORD or NIH funded randomized controlled trial.
Detailed Description:
There is a high rate of insomnia among Veterans, particularly those who have been exposed to potentially traumatic situations (e.g., combat exposure) yet few of these Veterans receive cognitive-behavioral therapy for insomnia (CBT-I), a first-line treatment for insomnia. In this pilot study we seek to evaluate if Insomnia Coach is a promising tool for individuals with traumatic stress who are experiencing sleep difficulties, and therefore, demonstrate that it has the potential to address a need using a very cost-effective, widely accessible, scalable solution that would warrant more rigorous evaluation (e.g., a full-scale RCT).
Thus, in this pilot randomized controlled trial (RCT), Veterans with significant insomnia and PTSD symptoms will be recruited using hardcopy and digital flyers and 130 will be enrolled and randomized in equal numbers (1:1) to receive one of two conditions: 1) the Insomnia Coach mobile app (which is based on cognitive-behavioral therapy for Insomnia \[CBT-I\]) or, 2) a web-based sleep education control (i.e., Sleep Well). We will track objective use of the Insomnia Coach mobile app to assess feasibility (i.e., will participants use the app as intended). Participants will complete measures (using VA REDCap) of sleep, insomnia severity, PTSD, depression and anxiety symptoms, and functional well-being at baseline, 8 weeks (post-treatment), and 16 weeks (follow-up). At post-treatment, participants in the Insomnia Coach condition will also be asked to report their level of satisfaction with the app.
Participants will be 130 Veterans with probable insomnia and probable PTSD. Potential participants will be screened for eligibility using VA's REDCap platform. If eligible, VA REDCap will be used to administer the informed consent documents and provide participants with access to complete the baseline self-report assessments. Participants who consent and complete the baseline assessment will then be randomized with an equal probability (1:1) to conditions. Those assigned to the Insomnia Coach condition will be provided with information about how to download the research version of Insomnia Coach. Objective app use data will be monitored. Those assigned to the sleep education control will be provided with a link to access the mobile-friendly website, called "Sleep Well". No PHI/IIHI will be collected on the app (Insomnia Coach) or website (Sleep Well). Likewise, no PHI/IIHI will be disclosed via the app or website. VA REDCap will be used to administer the post-treatment assessment (at 8 weeks) and the follow-up assessment (at 16 weeks).
Study:
NCT07083869
Study Brief:
Protocol Section:
NCT07083869