Insomnia Clinical Trial
Official title:
A Pilot Evaluation of the Insomnia Coach Mobile App
NCT number | NCT03826849 |
Other study ID # | IRB-47188 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 1, 2019 |
Est. completion date | July 1, 2020 |
Verified date | October 2021 |
Source | VA Palo Alto Health Care System |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 50 |
Est. completion date | July 1, 2020 |
Est. primary completion date | July 1, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 55 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | VA Palo Alto Health Care System | Palo Alto | California |
Lead Sponsor | Collaborator |
---|---|
VA Palo Alto Health Care System |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | Qualitative Interview (Kuhn & Miller, 2018) | A 24-question, semi-structured interview to assess users' perceptions of Insomnia Coach. | 6 weeks | |
Secondary | Insomnia Severity Index (ISI; Bastien et al., 2011) | A 7-item self-report questionnaire assessing the nature, severity, and impact of insomnia symptoms in the past month. Items are on a scale from 0 to 4. The seven answers are added up to get a total score, with higher scores reflecting greater insomnia severity | 6 and 12 weeks | |
Secondary | Pittsburgh Sleep Quality Index (PSQI; Buysse et al., 1989) | A 19-item self-report measure assessing qualities and problems associated with sleep in the past month. It generates seven component scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. A global sleep quality score is obtained by summing the seven component scores. Higher scores reflect poorer sleep quality. The global score ranges from 0 to 21, with a cut-off score of 5 as distinguishing "good" sleepers from "poor" sleepers. | 6 and 12 weeks | |
Secondary | PROMIS-Sleep-Related Impairment (PROMIS-SRI; Buysse et al., 2010) | This 16-item self-report form assesses sleep-related impairment over the past seven days. Each question has five response options ranging in value from 1 to 5. To find the total raw score the values of the response to each question are summed. The raw scores are converted to a standardized T-score using conversion tables published on the PROMIS website (nihpromis.org), with higher scores indicating greater sleep/wake disturbances. | 6 and 12 weeks | |
Secondary | Consensus Sleep Diary: Change in sleep onset latency (Carney et al., 2012) | The Consensus Sleep Diary will be used to prospectively monitor self-reported sleep. Shorter sleep onset indicates faster time to fall asleep. | 6 and 12 weeks | |
Secondary | Consensus Sleep Diary: Change in wake after sleep onset (Carney et al., 2012) | The Consensus Sleep Diary will be used to prospectively monitor self-reported sleep. Less time spent awake during the sleep period indicates better sleep. | 6 and 12 weeks | |
Secondary | Consensus Sleep Diary: Change in sleep efficiency (Carney et al., 2012) | The Consensus Sleep Diary will be used to prospectively monitor self-reported sleep. Higher sleep efficiency (total sleep time/time spent in bed) indicates better sleep quality. | 6 and 12 weeks | |
Secondary | Generalized Anxiety Disorder - 7 Item (GAD-7; Spitzer et al., 2006) | This 7-item measure assesses anxiety symptom severity. Items are scored from zero to three. The whole scale score can range from 0 to 21 and cut-off scores for mild, moderate and severe anxiety symptoms are 5, 10 and 15 respectively. | 6 and 12 weeks | |
Secondary | Patient Health Questionnaire 8 (PHQ-8; Kroenke et al., 2009) | An 8-item self-report instrument used to assess depression severity. Since the scale is self-administered in our studies and further probing about positive responses is not feasible, the question about suicide from the PHQ-9 was removed. Items are scored 0 to 3, with the total score being the sum of the 8 items. Higher scores indicate greater depression severity, with a score of 10 or greater considered major depression, and scores of 20 or more is severe major depression. | 6 and 12 weeks |
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