Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
50 participants
INTERVENTIONAL
2019-07-01
2020-07-01
Brief Summary
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Detailed Description
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* 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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Waitlist Control
Assessment only condition for all 12 weeks of participation.
No interventions assigned to this group
Insomnia Coach
Intervention condition that involves use of the Insomnia Coach app for 6 weeks.
Insomnia Coach
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)
Interventions
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Insomnia Coach
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)
Eligibility Criteria
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Inclusion Criteria
* Owner of smartphone or tablet with Android or iOS operating system
* Probable insomnia (i.e., ISI \>=10, 3 months or more with sxs, occurring \>= 3 days/week, 30 minutes or \> with sleep loss)
* Able to read/write English
* Internet connection and active email address
Exclusion Criteria
* Started or changed dosage of sleep medications or SSRIs in past 2 months
* Unstable housing
* Medical condition identifiably causing sleep problems
* Significant alcohol/drug use issues
* Current mania or psychosis
* Currently severely depressed (PHQ-9 \>20)
* Currently receiving or having recently received insomnia therapy resembling CBT-I
* Shift working
* Pregnant
* Newborn (3 mos. or younger) living in residence
* \< 5 hours of average total sleep time on 7 days of sleep diaries
18 Years
55 Years
ALL
Yes
Sponsors
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VA Palo Alto Health Care System
FED
Responsible Party
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Eric Kuhn
Clinical Psychologist
Locations
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VA Palo Alto Health Care System
Palo Alto, California, United States
Countries
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Other Identifiers
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IRB-47188
Identifier Type: -
Identifier Source: org_study_id