A Pilot Evaluation of the Insomnia Coach Mobile App
Condition: Insomnia; Trauma, Psychological
MeSH terms: Sleep Initiation and Maintenance Disorders; Psychological Trauma
Study type: Interventional

Summary: 
      This pilot study is designed to test the feasibility, acceptability, and potential
      effectiveness of a mobile phone application (app) developed by the VA National Center for
      PTSD (VA NCPTSD) for use by Veterans with insomnia. The primary objective is to assess
      whether Veterans find the Insomnia Coach app to be satisfactory and feasible to use.
      Secondary objectives are to determine if use of the app improves subjective sleep quality and
      sleep parameters (e.g., sleep latency, wake after sleep onset, and total sleep time), as well
      as other important outcomes (e.g., daily functioning).
    

Detailed description: 
      There are high rates of insomnia among Veterans, particularly those who have been exposed to
      potentially traumatic situations (i.e., combat exposure) and few receive cognitive-behavioral
      therapy for insomnia (CBT-I), a first-line treatment for insomnia. Insomnia Coach is a mobile
      app for individuals with insomnia symptoms. This app provides:

        -  education about sleep, the development of insomnia, and evidence based behavioral and
           cognitive strategies

        -  self-assessment tools measuring insomnia severity and sleep need

        -  self-monitoring with a daily sleep diary

        -  self-management tools for relaxation and changing thinking about sleep

        -  individualized recommendations for a preferable sleep window (i.e., bed and rise times)

        -  daily reminders for behavioral changes In this pilot randomized controlled trial (RCT),
           50 Veterans with significant insomnia symptoms will be recruited using flyers and social
           media (i.e., Facebook ads) and randomized in equal numbers to receive one of two
           conditions: 1) the Insomnia Coach mobile app (which is based on cognitive-behavioral
           therapy for insomnia (CBT-I)) and, 2) a waitlist control.

      Objective use of the Insomnia Coach mobile app will be tracked to assess feasibility (i.e.,
      will participants use the app as intended). Participants will complete measures (using
      Qualtrics) of sleep, insomnia severity, depression and anxiety, and functional well-being at
      baseline, 6 weeks (posttreatment), and 12 weeks (follow-up). At post-treatment, participants
      in the Insomnia Coach app condition will also be asked to report their level of satisfaction
      with the app and to complete a brief qualitative evaluation of their experience using the
      app. Waitlist control condition participants will be informed about the Insomnia Coach app
      and provided with information on how to download it after completion of the follow-up
      assessment (i.e., at 12 weeks).

      The aim of this research is to learn whether individuals, particularly Veterans, with
      insomnia, find Insomnia Coach to be satisfactory and feasible to use. It also aims to assess
      if use of the app potentially improves subjective sleep quality and sleep parameters (e.g.,
      sleep latency, wake after sleep onset, and total sleep time), as well as other important
      outcomes (e.g., daily functioning). If this research demonstrates that Insomnia Coach is a
      promising tool for individuals experiencing sleep difficulties, 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).
    

Intervention name(s): Insomnia Coach
Intervention type(s): Behavioral
Intervention description(s): Insomnia Coach is a mobile application that provides psychoeducation and self-management tools for insomnia symptoms based on cognitive behavioral therapy for insomnia (CBT-I)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: mobile app; Veteran; cognitive behavioral therapy for insomnia