Clinical trial NCT03826849: A Pilot Evaluation of the Insomnia Coach Mobile App
Official title: A Pilot Evaluation of the Insomnia Coach Mobile App
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Trauma, Psychological
Keywords: mobile app
Veteran
cognitive behavioral therapy for insomnia
Lead sponsor: VA Palo Alto Health Care System
Sponsor class: FED
First posted: 2019-02-01
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Eligibility criteria: 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

Primary outcomes:
measure: Objective App Usage Data
timeFrame: 6 weeks
measure: Mobile Apps Rating Scale (MARS; Stoyanov et al., 2015)
timeFrame: 6 weeks
measure: System Usability Scale (SUS; Brooke, 1986)
timeFrame: 6 weeks
measure: Qualitative Interview (Kuhn & Miller, 2018)
timeFrame: 6 weeks
Secondary outcomes:
measure: Insomnia Severity Index (ISI; Bastien et al., 2011)
timeFrame: 6 and 12 weeks
measure: Pittsburgh Sleep Quality Index (PSQI; Buysse et al., 1989)
timeFrame: 6 and 12 weeks
measure: PROMIS-Sleep-Related Impairment (PROMIS-SRI; Buysse et al., 2010)
timeFrame: 6 and 12 weeks
measure: Consensus Sleep Diary: Change in sleep onset latency (Carney et al., 2012)
timeFrame: 6 and 12 weeks
measure: Consensus Sleep Diary: Change in wake after sleep onset (Carney et al., 2012)
timeFrame: 6 and 12 weeks
measure: Consensus Sleep Diary: Change in sleep efficiency (Carney et al., 2012)
timeFrame: 6 and 12 weeks
measure: Generalized Anxiety Disorder - 7 Item (GAD-7; Spitzer et al., 2006)
timeFrame: 6 and 12 weeks
measure: Patient Health Questionnaire 8 (PHQ-8; Kroenke et al., 2009)
timeFrame: 6 and 12 weeks
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: VA Palo Alto Health Care System
state: California
Study officials:
References: