A Pilot Evaluation of the Insomnia Coach Mobile App

VA Palo Alto Health Care System

Status

Completed

Conditions

Trauma, Psychological

Insomnia

Treatments

Behavioral: Insomnia Coach

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT03826849

IRB-47188

Details and patient eligibility

About

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).

Full 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).

Enrollment

50 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Age 18 to 55
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

Comorbid sleep disorders (apnea, RLS, narcolepsy)*
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