InsomniaNCT03826849
A Pilot Evaluation of the Insomnia Coach Mobile App
A study testing Insomnia Coach in people with Insomnia and Trauma, Psychological, run by VA Palo Alto Health Care System at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Insomnia, Trauma, Psychological
- What is being tested?
- Insomnia Coach
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2019to 1 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Palo Alto Health Care System
Palo Alto, California, 94025
About this study
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).
Read the 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).
- Conditions
- Insomnia, Trauma, Psychological
- Being tested
- Insomnia Coach
- Keywords
- mobile app, Veteran, cognitive behavioral therapy for insomnia
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Psychological Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insomnia CoachBehavioural
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)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Insomnia Coach |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 6 weeks
Qualitative Interview (Kuhn & Miller, 2018)
A 24-question, semi-structured interview to assess users' perceptions of Insomnia Coach.
Measured: 6 weeks
Secondary outcomes (8)
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
Measured: 6 and 12 weeks
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.
Measured: 6 and 12 weeks
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.
Measured: 6 and 12 weeks
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.
Measured: 6 and 12 weeks
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.
Measured: 6 and 12 weeks
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.
Measured: 6 and 12 weeks
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.
Measured: 6 and 12 weeks
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.
Measured: 6 and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2019
- Study start1 Jul 2019
- Primary completion1 Jul 2020
- Study completion1 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Palo Alto Health Care System
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Eric Kuhn, VA Palo Alto Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03826849
- Sponsor's protocol ID
- IRB-47188
- Status last verified
- Oct 2021
- First submitted
- 4 Jan 2019
- Last updated
- 15 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Evaluation of the Insomnia Coach Mobile App
- ClinicalTrials.gov ID
- NCT03826849
- Acronym / sponsor ID
- IRB-47188
- Conditions
- Insomnia, Trauma, Psychological
- Keywords
- mobile app, Veteran, cognitive behavioral therapy for insomnia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- VA Palo Alto Health Care SystemUS federal agency
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 1 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Waitlist Control | No intervention | –Assessment only condition for all 12 weeks of participation. |
| Insomnia Coach | Experimental | Behavioral: Insomnia CoachIntervention condition that involves use of the Insomnia Coach app for 6 weeks. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Insomnia CoachInsomnia Coach is a mobile application that provides psychoeducation and self-management tools for insomnia symptoms based on cognitive behavioral therapy for insomnia (CBT-I) | Behavioural | Insomnia Coach |
Primary outcome
Objective App Usage Data
Time frame: 6 weeks
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.
Mobile Apps Rating Scale (MARS; Stoyanov et al., 2015)
Time frame: 6 weeks
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.
System Usability Scale (SUS; Brooke, 1986)
Time frame: 6 weeks
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.
Qualitative Interview (Kuhn & Miller, 2018)
Time frame: 6 weeks
A 24-question, semi-structured interview to assess users' perceptions of Insomnia Coach.
8 secondary outcomes
Insomnia Severity Index (ISI; Bastien et al., 2011)
Time frame: 6 and 12 weeks
Pittsburgh Sleep Quality Index (PSQI; Buysse et al., 1989)
Time frame: 6 and 12 weeks
PROMIS-Sleep-Related Impairment (PROMIS-SRI; Buysse et al., 2010)
Time frame: 6 and 12 weeks
Consensus Sleep Diary: Change in sleep onset latency (Carney et al., 2012)
Time frame: 6 and 12 weeks
Consensus Sleep Diary: Change in wake after sleep onset (Carney et al., 2012)
Time frame: 6 and 12 weeks
Consensus Sleep Diary: Change in sleep efficiency (Carney et al., 2012)
Time frame: 6 and 12 weeks
Generalized Anxiety Disorder - 7 Item (GAD-7; Spitzer et al., 2006)
Time frame: 6 and 12 weeks
Patient Health Questionnaire 8 (PHQ-8; Kroenke et al., 2009)
Time frame: 6 and 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Insomnia Coach in people with Insomnia and Trauma, Psychological, run by VA Palo Alto Health Care System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective App Usage Data (time frame: 6 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2021; AzTrials last refreshed its copy on 6 Nov 2026.