A Pilot Evaluation of the Insomnia Coach Mobile App

NCT03826849 | Completed

• 1 other identifier: IRB-47188
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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).

Conditions

Insomnia; Trauma, Psychological

Keywords

mobile app; Veteran; cognitive behavioral therapy for insomnia

Outcome Measures

Primary Outcomes (4)

• Objective App Usage Data

  Composite of app usage data comprised of button taps, sections visited, self-entered data, number of visits and days used, and time spent on the app per visit. Various combinations and aggregations of these behaviors will be explored as best indicators to optimally summarize app use.

  6 weeks

• Mobile Apps Rating Scale (MARS; Stoyanov et al., 2015)

  A 20-item multidimensional, objective measure of app usability. It includes four subscales that measure an app's engagement, functionality, aesthetics, and information quality. All items are rated on a 5-point scale from "1. Inadequate" to "5. Excellent". The scores are tallied up and a mean score out of 5 is given to each of the categories scored.

  6 weeks

• System Usability Scale (SUS; Brooke, 1986)

  A 10-item questionnaire of usability of products and services, including hardware, software, mobile devices, websites and applications. Items are on a 5-point scale numbered 1 to 5. Half of the items are worded negatively and half are worded positively. SUS yields a single number representing a composite measure of the overall usability of the system. To calculate the SUS score, the score contributions from each item are summed. Each item's score contribution will range from 0 to 4. For items 1,3,5,7,and 9 the score contribution is the scale position minus 1. For items 2,4,6,8 and 10, the contribution is 5 minus the scale position. Then the sum of the scores is multiplied by 2.5 to obtain the overall value of SU. SUS scores have a range of 0 to 100.

  6 weeks

• Qualitative Interview (Kuhn & Miller, 2018)

  A 24-question, semi-structured interview to assess users' perceptions of Insomnia Coach.

  6 weeks

Secondary Outcomes (8)

• Insomnia Severity Index (ISI; Bastien et al., 2011)

  6 and 12 weeks

• Pittsburgh Sleep Quality Index (PSQI; Buysse et al., 1989)

  6 and 12 weeks

• PROMIS-Sleep-Related Impairment (PROMIS-SRI; Buysse et al., 2010)

  6 and 12 weeks

• Consensus Sleep Diary: Change in sleep onset latency (Carney et al., 2012)

  6 and 12 weeks

• Consensus Sleep Diary: Change in wake after sleep onset (Carney et al., 2012)

  6 and 12 weeks

Study Arms (2)

Waitlist Control

NO INTERVENTION

Assessment only condition for all 12 weeks of participation.

Insomnia Coach

EXPERIMENTAL

Intervention condition that involves use of the Insomnia Coach app for 6 weeks.

Behavioral: Insomnia Coach

Interventions

Insomnia Coach BEHAVIORAL

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)

Insomnia Coach

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Palo Alto Health Care System: lead

Study Sites (1)

VA Palo Alto Health Care System

Palo Alto, California, 94025, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Psychological Trauma

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Psychologist

Study Record Dates

• First Submitted: January 4, 2019
• First Posted: February 1, 2019
• Study Start: July 1, 2019
• Primary Completion: July 1, 2020
• Study Completion: July 1, 2020
• Last Updated: October 15, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)