InsomniaNCT07083869
Testing the Insomnia Coach Mobile App With Veterans With Insomnia and PTSD
A study testing Insomnia Coach and Sleep Well in people with Insomnia and Posttraumatic Stress Disorder (PTSD), run by VA Palo Alto Health Care System.
Trial summary
The objective of this randomized controlled trial of the Insomnia Coach mobile app is to evaluate the potential effects of app use on reducing insomnia symptoms among Veterans with significant insomnia and PTSD symptoms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insomnia, Posttraumatic Stress Disorder (PTSD)
- What is being tested?
- Insomnia Coach and Sleep Well
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- U.S. military Veteran
- Aged 18 years or older
- Owner of smartphone or tablet with Android or iOS operating system
- Probable insomnia (i.e., ISI >=15)
- Probable PTSD (i.e., PCL-5 >=31)
- 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
- Current mania or psychosis or seizure-related disorder
- Currently receiving or having recently received insomnia therapy resembling CBT-I
Show all 9Show fewer
- Shift working
- Pregnant
- Newborn (3 mos. or younger) living in residence
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The objective of this randomized controlled trial of the Insomnia Coach mobile app is to evaluate the potential effects of app use on reducing insomnia symptoms among Veterans with significant insomnia and PTSD symptoms. It is also intended to evaluate the impact of the app on other outcomes, including PTSD, depression, and anxiety symptoms, and psychosocial functioning. Finally, the study is designed to assess perceptions of Insomnia Coach regarding its perceived helpfulness, satisfaction, and likes/dislikes to inform its continued improvement. The results of this study will inform the next steps of research evaluating Insomnia Coach with Veterans with significant insomnia and PTSD symptoms, namely a larger-scale, VA ORD or NIH funded randomized controlled trial.
Read the detailed description
There is a high rate of insomnia among Veterans, particularly those who have been exposed to potentially traumatic situations (e.g., combat exposure) yet few of these Veterans receive cognitive-behavioral therapy for insomnia (CBT-I), a first-line treatment for insomnia. In this pilot study we seek to evaluate if Insomnia Coach is a promising tool for individuals with traumatic stress who are experiencing sleep difficulties, and therefore, demonstrate that 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).
Thus, in this pilot randomized controlled trial (RCT), Veterans with significant insomnia and PTSD symptoms will be recruited using hardcopy and digital flyers and 130 will be enrolled and randomized in equal numbers (1:1) to receive one of two conditions: 1) the Insomnia Coach mobile app (which is based on cognitive-behavioral therapy for Insomnia [CBT-I]) or, 2) a web-based sleep education control (i.e., Sleep Well). We will track objective use of the Insomnia Coach mobile app to assess feasibility (i.e., will participants use the app as intended). Participants will complete measures (using VA REDCap) of sleep, insomnia severity, PTSD, depression and anxiety symptoms, and functional well-being at baseline, 8 weeks (post-treatment), and 16 weeks (follow-up). At post-treatment, participants in the Insomnia Coach condition will also be asked to report their level of satisfaction with the app.
Participants will be 130 Veterans with probable insomnia and probable PTSD. Potential participants will be screened for eligibility using VA's REDCap platform. If eligible, VA REDCap will be used to administer the informed consent documents and provide participants with access to complete the baseline self-report assessments. Participants who consent and complete the baseline assessment will then be randomized with an equal probability (1:1) to conditions. Those assigned to the Insomnia Coach condition will be provided with information about how to download the research version of Insomnia Coach. Objective app use data will be monitored. Those assigned to the sleep education control will be provided with a link to access the mobile-friendly website, called "Sleep Well". No PHI/IIHI will be collected on the app (Insomnia Coach) or website (Sleep Well). Likewise, no PHI/IIHI will be disclosed via the app or website. VA REDCap will be used to administer the post-treatment assessment (at 8 weeks) and the follow-up assessment (at 16 weeks).
- Conditions
- Insomnia, Posttraumatic Stress Disorder (PTSD)
- Being tested
- Insomnia Coach, Sleep Well
- Keywords
- Mobile app, Veteran, Cognitive Behavioral Therapy for Insomnia
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Stress Disorders, Post-Traumatic
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)
Sleep WellBehavioural
Sleep Well is a website that is mobile enabled that provides psychoeducation about healthy sleep habits that is based on NIH Health Guide to Health Sleep and VA's Whole Health Change Your Habits to Sleep Better.
| Study group | Role | What they receive |
|---|---|---|
| Insomnia Coach Mobile App | Experimental | 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). Receives: Behavioral: Insomnia Coach |
| Sleep Well Website | Active comparator | Sleep Well is a website that is mobile enabled that provides psychoeducation about healthy sleep habits that is based on NIH Health Guide to Health Sleep and VA's Whole Health Change Your Habits to Sleep Better. Receives: Behavioral: Sleep Well |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 8 and 16 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: 8 and 16 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: 8 and 16 weeks
Secondary outcomes (9)
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: 8 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: 8 and 16 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: 8 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: 8 weeks
Dysfunctional Beliefs and Attitudes about Sleep (DBAS-16; Morin et al., 2007).
This 16-item self-report measures attitudes and beliefs about sleep in 4 domains: consequences of insomnia, worry and helplessness about sleep, sleep expectations, and sleep medications. Items are rated from 1 (strongly disagree) to 10 (strongly agree). An average score is calculated, with higher scores indicating stronger endorsement of unhelpful sleep cognitions.
Measured: 8 and 12 weeks
PTSD Checklist for DSM-5 (PCL-5; Weathers et al., 2013)
A 20-item self-report questionnaire assessing PTSD symptoms in the past month. Items are on a scale from 0 to 4. The 20 item responses are summed to get a total score, with higher scores reflecting greater PTSD symptom severity
Measured: 8 and 16 weeks
WHO QOL-BREF (Murphy et al., 2000)
This 26-item self-report measure of quality of life (QOL), life satisfaction, and personal well-being assesses the broad domains of physical health, psychological health, social relationships, and environmental factors (e.g., finances, safety). Item are rated on a variety of 1 to 5 scales with domain score items being summed to generate subscale scores with higher scores reflecting more higher QOL etc.
Measured: 8 and 16 weeks
Fear of Sleep Inventory Short Form (FoSI-SF; Pruiksma et al., 2014)
The FoSI-SF is a 13-item self-report measure that assesses trauma-related thoughts and activities associated with sleep and the occurrence of traumas associated with the bedroom or sleep. Items are rated from 0 (not at all) to 4 (nearly every night). Total scores range from 0 to 52, with higher scores indicating greater fear of sleep.
Measured: 8 and 16 weeks
Disturbing Dream and Nightmare Severity Index (DDNSI-15; Krakow et al., 2000)
The DDNSI is a self-report measure that assesses number of nights of nightmares, number of nightmares per week, frequency of awakenings (0 = never/rarely to 4 = always), intensity (0 = not intense to 6 = extremely severe intensity) and severity (0 = no problem to 6 = very severe problem). Scores range between 0 and 37, with a score ≥10 suggestive of nightmare disorder.
Measured: 8 and 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study start1 Aug 2025 (estimated)
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
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
- 130 participants (estimated)
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
- NCT07083869
- Sponsor's protocol ID
- IRB-79382
- Status last verified
- Jul 2025
- First submitted
- 3 Jul 2025
- Last updated
- 24 Jul 2025
- 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 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Insomnia Coach Mobile App With Veterans With Insomnia and PTSD
- ClinicalTrials.gov ID
- NCT07083869
- Acronym / sponsor ID
- IRB-79382
- Conditions
- Insomnia, Posttraumatic Stress Disorder (PTSD)
- Keywords
- Mobile app, Veteran, Cognitive Behavioral Therapy for Insomnia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- VA Palo Alto Health Care SystemUS federal agency
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 24 Jul 2025 (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.
The objective of this randomized controlled trial of the Insomnia Coach mobile app is to evaluate the potential effects of app use on reducing insomnia symptoms among Veterans with significant insomnia and PTSD symptoms. It is also intended to evaluate the impact of the app on other outcomes, including PTSD, depression, and anxiety symptoms, and psychosocial functioning. Finally, the study is designed to assess perceptions of Insomnia Coach regarding its perceived helpfulness, satisfaction, and likes/dislikes to inform its continued improvement. The results of this study will inform the next steps of research evaluating Insomnia Coach with Veterans with significant insomnia and PTSD symptoms, namely a larger-scale, VA ORD or NIH funded randomized controlled trial.
Detailed description
There is a high rate of insomnia among Veterans, particularly those who have been exposed to potentially traumatic situations (e.g., combat exposure) yet few of these Veterans receive cognitive-behavioral therapy for insomnia (CBT-I), a first-line treatment for insomnia. In this pilot study we seek to evaluate if Insomnia Coach is a promising tool for individuals with traumatic stress who are experiencing sleep difficulties, and therefore, demonstrate that 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).
Thus, in this pilot randomized controlled trial (RCT), Veterans with significant insomnia and PTSD symptoms will be recruited using hardcopy and digital flyers and 130 will be enrolled and randomized in equal numbers (1:1) to receive one of two conditions: 1) the Insomnia Coach mobile app (which is based on cognitive-behavioral therapy for Insomnia [CBT-I]) or, 2) a web-based sleep education control (i.e., Sleep Well). We will track objective use of the Insomnia Coach mobile app to assess feasibility (i.e., will participants use the app as intended). Participants will complete measures (using VA REDCap) of sleep, insomnia severity, PTSD, depression and anxiety symptoms, and functional well-being at baseline, 8 weeks (post-treatment), and 16 weeks (follow-up). At post-treatment, participants in the Insomnia Coach condition will also be asked to report their level of satisfaction with the app.
Participants will be 130 Veterans with probable insomnia and probable PTSD. Potential participants will be screened for eligibility using VA's REDCap platform. If eligible, VA REDCap will be used to administer the informed consent documents and provide participants with access to complete the baseline self-report assessments. Participants who consent and complete the baseline assessment will then be randomized with an equal probability (1:1) to conditions. Those assigned to the Insomnia Coach condition will be provided with information about how to download the research version of Insomnia Coach. Objective app use data will be monitored. Those assigned to the sleep education control will be provided with a link to access the mobile-friendly website, called "Sleep Well". No PHI/IIHI will be collected on the app (Insomnia Coach) or website (Sleep Well). Likewise, no PHI/IIHI will be disclosed via the app or website. VA REDCap will be used to administer the post-treatment assessment (at 8 weeks) and the follow-up assessment (at 16 weeks).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Insomnia Coach Mobile App | Experimental | Behavioral: 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). |
| Sleep Well Website | Active comparator | Behavioral: Sleep WellSleep Well is a website that is mobile enabled that provides psychoeducation about healthy sleep habits that is based on NIH Health Guide to Health Sleep and VA's Whole Health Change Your Habits to Sleep Better. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- U.S. military Veteran
- Aged 18 years or older
- Owner of smartphone or tablet with Android or iOS operating system
- Probable insomnia (i.e., ISI >=15)
- Probable PTSD (i.e., PCL-5 >=31)
Key exclusion criteria (9 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
- Current mania or psychosis or seizure-related disorder
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 Mobile App |
| Sleep WellSleep Well is a website that is mobile enabled that provides psychoeducation about healthy sleep habits that is based on NIH Health Guide to Health Sleep and VA's Whole Health Change Your Habits to Sleep Better. | Behavioural | Sleep Well Website |
Primary outcome
Insomnia Severity Index (ISI; Bastien et al., 2011)
Time frame: 8 and 16 weeks
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
Pittsburgh Sleep Quality Index (PSQI; Buysse et al., 1989)
Time frame: 8 and 16 weeks
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.
PROMIS-Sleep-Related Impairment (PROMIS-SRI; Buysse et al., 2010)
Time frame: 8 and 16 weeks
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.
9 secondary outcomes
Generalized Anxiety Disorder - 7 Item (GAD-7; Spitzer et al., 2006)
Time frame: 8 and 12 weeks
Patient Health Questionnaire 8 (PHQ-8; Kroenke et al., 2009)
Time frame: 8 and 16 weeks
Mobile Apps Rating Scale (MARS; Stoyanov et al., 2015)
Time frame: 8 weeks
System Usability Scale (SUS; Brooke, 1986)
Time frame: 8 weeks
Dysfunctional Beliefs and Attitudes about Sleep (DBAS-16; Morin et al., 2007).
Time frame: 8 and 12 weeks
PTSD Checklist for DSM-5 (PCL-5; Weathers et al., 2013)
Time frame: 8 and 16 weeks
WHO QOL-BREF (Murphy et al., 2000)
Time frame: 8 and 16 weeks
Fear of Sleep Inventory Short Form (FoSI-SF; Pruiksma et al., 2014)
Time frame: 8 and 16 weeks
Disturbing Dream and Nightmare Severity Index (DDNSI-15; Krakow et al., 2000)
Time frame: 8 and 16 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2025.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Insomnia Coach and Sleep Well in people with Insomnia and Posttraumatic Stress Disorder (PTSD), run by VA Palo Alto Health Care System.
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 7 inclusion and 9 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: opening soon, as of the sponsor's last update on 24 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eric R. Kuhn, Ph.D. (650-493-5000 ext. 23160, eric.kuhn@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insomnia Severity Index (ISI; Bastien et al., 2011) (time frame: 8 and 16 weeks). The study lists 3 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 24 Jul 2025.