InsomniaNCT07335276
Enhancing Operational Readiness With Digital Self-Managed Cognitive Behavioral Therapy for Insomnia (CBTI)
A study testing Cognitive Behavioral Therapy for Insomnia in people with Insomnia and Depression - Major Depressive Disorder, run by Madigan Army Medical Center.
Trial summary
The goal of this pilot clinical trial is to evaluate the effectiveness and delivery method of a CBTI self-managed digital mobile application in service members. The main questions it aims to answer are: RQ1. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Insomnia, Depression - Major Depressive Disorder, PTSD
- What is being tested?
- Cognitive Behavioral Therapy for Insomnia
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2026to 2 Oct 2028
- 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 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Active Duty, Reservist, Army National Guard
- Ages 18-55 years
- Own a smart phone
- Internet access
Who cannot join
- Insomnia Severity Score > or equal to 10
- PHQ-8 score <20
- Untreated sleep disorders (sleep apnea, narcolepsy, parasomnias)
- Pregnancy
- Working rotating Shifts
- Caring for a newborn <3 months old
- Currently receiving cognitive behavioral therapy for insomnia
- Received cognitive behavioral therapy for insomnia in the last 6 months
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
Official title: Enhancing Operational Readiness With Digital Self-Managed Cognitive Behavioral Therapy for Insomnia (CBTI): A Pilot Randomized Controlled Trial for Service Members
The goal of this pilot clinical trial is to evaluate the effectiveness and delivery method of a CBTI self-managed digital mobile application in service members.
The main questions it aims to answer are:
RQ1. Will the delivery of CBTI via a self-managed mobile application over five weeks improve sleep outcomes for service members?
RQ2. Will the delivery of CBTI via a self-managed mobile application over five weeks improve secondary outcomes (sleep-related impairment, depression, PTSD symptoms, and quality of life) for service members?
Read the detailed description
Participants enrolled in this trial will:
- Week 1: Complete a series of questionnaires (approximately 15 minutes) \& complete a daily sleep diary for one week (three minutes each morning).
- Weeks 2-6: Participate in one of two groups that are randomly assigned:
- Group 1: Starts use of the smart phone app with treatment for insomnia for five weeks. Each day during weeks 2-6 you will complete a daily sleep diary on the app and review individual sleep treatment recommendations (total of 5 minutes each morning).
OR
- Group 2: Will wait for five weeks
- End of Week 6: Both Group 1 \& Group 2 will complete a series of questionnaires (approximately 15 minutes), \& complete a daily sleep diary for one week (three minutes each morning).
- Week 10: Both Group 1 \& Group 2 will complete a series of questionnaires (approximately 15 minutes) about insomnia symptoms, any sleep related impaired function, depression symptoms, post-traumatic stress disorder symptoms, and quality of life. Participants randomized to the wait list will be contacted to provide information and support on how to use the smart phone app for treatment with insomnia.
- Conditions
- Insomnia, Depression - Major Depressive Disorder, PTSD
- Being tested
- Cognitive Behavioral Therapy for Insomnia
- Keywords
- Insomnia, Service Members, Cognitive Behavioral Therapy for Insomnia, Digital Application
- 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.
Cognitive Behavioral Therapy for InsomniaBehavioural
This intervention will be delivered via a smart phone app
| Study group | Role | What they receive |
|---|---|---|
| Digital App CBTI | Experimental | Participants will use a digital app for self-directed CBTI for five weeks. Receives: Behavioral: Cognitive Behavioral Therapy for Insomnia |
| Waitlist Control | No intervention | This group will be placed on a waitlist control group until the follow up period is complete. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia Severity
Insomnia severity will be measured with the Insomnia Severity Index (ISI). The ISI is a seven-item self-report questionnaire assessing the nature, severity, and impact of insomnia symptoms in the past 2 weeks. Items are rated on scales from 0 - 4 (none-severe). Item ratings are summed to get a total score, with higher scores reflecting greater insomnia severity (0-7 = no clinically significant insomnia, 8-14 = subthreshold insomnia, 15-21 = clinically significant insomnia -moderate, 22-28 = clinically significant insomnia - severe).
Measured: Baseline, Six Weeks, Nine Weeks
Secondary outcomes (5)
Consensus Sleep Diary
Subjective sleep measures will be captured using the Consensus Sleep Diary (CSD). The CSD is a nine-item tool which provides participant reported daily sleep patterns and sleep outcome measures. The CSD was developed by leading sleep experts in an effort to create a standardized sleep diary for clinicians and researchers. Sleep diaries have been regarded as a gold standard for subjective sleep assessment, and are viewed by sleep experts as a useful methodology for prospective self-monitoring of sleep for individuals with insomnia. Through simple questions delivered via the Insomnia Coach app, participants are asked to report daytime napping, bedtime, time attempted to fall asleep, sleep onset latency (SOL), number of awakenings (NOA), wake after sleep onset (WASO), total sleep time (TST), time of awakening, sleep efficiency (SE), and sleep quality using a 5-point scale from 1-5 (1 = "very poor," 2 = "poor," 3 = "fair," 4 = "good," 5 = "very good").
Measured: Baseline, Six Weeks
PROMIS Sleep-Related Impairment 8a
The PROMIS Sleep-Related Impairment 8a (PROMIS-SRI 8a) is an 8-item self-report measure assesses daytime sleep-related impairment (SRI) over the past seven days. The PROMIS Sleep-Related Impairment 8a is the short form of the PROMIS-SRI 16. Each item has five response options ranging from 1- 5 (1 = "not at all," 2 = "a little bit," 3 = "somewhat," 4 = "quite a bit," 5 = "very much"). Higher scores indicating greater daytime function disturbances (range 0-40). Item ratings are summed to compute a raw score, which is converted to a standardized T score using conversion tables published on the Patient-Reported Outcomes Measurement Information System (PROMIS) website (nihpromis.org).
Measured: Baseline, Six Weeks, Nine Weeks
The Post Traumatic Stress Disorder Checklist-Military Version (PCL-M)
The Post Traumatic Stress Disorder Checklist-Military Version (PCL-M) is a self-report questionnaire designed to assess the symptoms of PTSD in which 17 items correspond to the Diagnostic and Statistical Manual of Mental Disorders PTSD criteria. Items one through five correspond to re-experiencing symptoms, items five and six correspond to avoidance symptoms, items eight through twelve correspond to numbing symptoms, and items thirteen through seventeen correspond to hyperarousal symptoms. Individuals are asked to endorse the level of distress with each symptom over the last 30 days. Items are scored on a five-point Likert scale with 1 = "not at all" to 5 = "extremely." A total symptom severity score is obtained (range 17-85), with higher scores indicating higher PTSD symptoms and scores greater than 50 indicating a high likelihood of PTSD diagnosis.
Measured: Baseline, Six Weeks, Ten Weeks
The Patient Health Questionnaire-8 (PHQ-8)
The Patient Health Questionnaire-8 (PHQ-8) is an eight item self-report questionnaire used to examine depression severity with similar psychometric properties of the PHQ-9. The PHQ-8 omits the final question of the PHQ-9 regarding suicide as the electronic delivery of the instruments may not provide timely clinical response to a positive endorsement of this question. Individuals are asked to endorse the level of distress with each symptom on the PHQ-9 in the last two weeks. A four-point Likert scale with 0 = "not at all," 1 = "several days," 2 = "more than half the days," and 3 = "nearly every day" is used. A total symptom severity score is obtained (range 0-24). Severity of depression is scored as follows: 0-4 no significant depression, 5-9 mild depression, 10-14 moderate depression, 15-19 moderately severe depression, 20-24 severe depression. Scores greater than ten indicate a high likelihood of depression.
Measured: Baseline, Six Weeks, Nine Weeks
RAND-36 Item Short Form Survey
The RAND-36 Item Short Form Survey (RAND-36) is a health-related quality of life questionnaire that assesses how health impacts on an individual's ability to function \& their perceived well-being in physical, mental and social domains of life. The RAND-36 includes a total of 36 items which includes eight domains representing aspects of health and quality of life: physical functioning (10 items), bodily pain (2 items), role limitations due to physical health problems (4 items), role limitations due to personal or emotional problems (4 items), emotional well-being (5 items), social functioning (2 items), energy/fatigue (4 items), and general health perceptions (5 items). Each domain includes either Likert type questions (with either 1-5 or 1-3 scales) and binary yes/no questions. The 36 items are grouped by the eight domains and each domain has a profile score (range 0-100). Higher scores within each domain indicate better health, higher quality of life, and less functional limitation.
Measured: Baseline, Six Weeks, Ten Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start1 Nov 2026 (estimated)
- Primary completion2 Oct 2027 (estimated)
- Study completion2 Oct 2028 (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
- Model description
- Study design is a prospective, randomized controlled trial with two arms (intervention and wait list control).
- Masking
- None (open label)
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Madigan Army Medical Center
- Sponsor type
- US federal agency
- Collaborators
- TriService Nursing Research Program (Funder)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07335276
- Sponsor's protocol ID
- 11207-N25-D03
- Status last verified
- Jan 2026
- First submitted
- 5 Jan 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Participant de-identified data sharing has not been determined at this point in time. Considerations include this data is DoD data and since the study has not started, it is unknown how much data or the quality of the data that will be obtained.
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Operational Readiness With Digital Self-Managed Cognitive Behavioral Therapy for Insomnia (CBTI): A Pilot Randomized Controlled Trial for Service Members
- ClinicalTrials.gov ID
- NCT07335276
- Acronym / sponsor ID
- 11207-N25-D03
- Conditions
- Insomnia, Depression - Major Depressive Disorder, PTSD
- Keywords
- Insomnia, Service Members, Cognitive Behavioral Therapy for Insomnia, Digital Application
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Madigan Army Medical CenterUS federal agency
- Collaborators
- TriService Nursing Research Program (Funder)
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 2 Oct 2027 (estimated)
- Study completion
- 2 Oct 2028 (estimated)
- First posted
- 13 Jan 2026 (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 goal of this pilot clinical trial is to evaluate the effectiveness and delivery method of a CBTI self-managed digital mobile application in service members.
The main questions it aims to answer are:
RQ1. Will the delivery of CBTI via a self-managed mobile application over five weeks improve sleep outcomes for service members?
RQ2. Will the delivery of CBTI via a self-managed mobile application over five weeks improve secondary outcomes (sleep-related impairment, depression, PTSD symptoms, and quality of life) for service members?
Detailed description
Participants enrolled in this trial will:
- Week 1: Complete a series of questionnaires (approximately 15 minutes) \& complete a daily sleep diary for one week (three minutes each morning).
- Weeks 2-6: Participate in one of two groups that are randomly assigned:
- Group 1: Starts use of the smart phone app with treatment for insomnia for five weeks. Each day during weeks 2-6 you will complete a daily sleep diary on the app and review individual sleep treatment recommendations (total of 5 minutes each morning).
OR
- Group 2: Will wait for five weeks
- End of Week 6: Both Group 1 \& Group 2 will complete a series of questionnaires (approximately 15 minutes), \& complete a daily sleep diary for one week (three minutes each morning).
- Week 10: Both Group 1 \& Group 2 will complete a series of questionnaires (approximately 15 minutes) about insomnia symptoms, any sleep related impaired function, depression symptoms, post-traumatic stress disorder symptoms, and quality of life. Participants randomized to the wait list will be contacted to provide information and support on how to use the smart phone app for treatment with insomnia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Study design is a prospective, randomized controlled trial with two arms (intervention and wait list control).
| Arm | Type | Receives |
|---|---|---|
| Digital App CBTI | Experimental | Behavioral: Cognitive Behavioral Therapy for InsomniaParticipants will use a digital app for self-directed CBTI for five weeks. |
| Waitlist Control | No intervention | –This group will be placed on a waitlist control group until the follow up period is complete. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Active Duty, Reservist, Army National Guard
- Ages 18-55 years
- Own a smart phone
- Internet access
Key exclusion criteria (8 listed)
- Insomnia Severity Score > or equal to 10
- PHQ-8 score <20
- Untreated sleep disorders (sleep apnea, narcolepsy, parasomnias)
- Pregnancy
- Working rotating Shifts
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 |
|---|---|---|
| Cognitive Behavioral Therapy for InsomniaThis intervention will be delivered via a smart phone app | Behavioural | Digital App CBTI |
Primary outcome
Insomnia Severity
Time frame: Baseline, Six Weeks, Nine Weeks
Insomnia severity will be measured with the Insomnia Severity Index (ISI). The ISI is a seven-item self-report questionnaire assessing the nature, severity, and impact of insomnia symptoms in the past 2 weeks. Items are rated on scales from 0 - 4 (none-severe). Item ratings are summed to get a total score, with higher scores reflecting greater insomnia severity (0-7 = no clinically significant insomnia, 8-14 = subthreshold insomnia, 15-21 = clinically significant insomnia -moderate, 22-28 = clinically significant insomnia - severe).
5 secondary outcomes
Consensus Sleep Diary
Time frame: Baseline, Six Weeks
PROMIS Sleep-Related Impairment 8a
Time frame: Baseline, Six Weeks, Nine Weeks
The Post Traumatic Stress Disorder Checklist-Military Version (PCL-M)
Time frame: Baseline, Six Weeks, Ten Weeks
The Patient Health Questionnaire-8 (PHQ-8)
Time frame: Baseline, Six Weeks, Nine Weeks
RAND-36 Item Short Form Survey
Time frame: Baseline, Six Weeks, Ten 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 22 Oct 2026.
- Individual participant dataSharing planned: Undecided. Participant de-identified data sharing has not been determined at this point in time. Considerations include this data is DoD data and since the study has not started, it is unknown how much data or the quality of the data that will be obtained.
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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 Cognitive Behavioral Therapy for Insomnia in people with Insomnia and Depression - Major Depressive Disorder, run by Madigan Army Medical Center.
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 4 inclusion and 8 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 22 Oct 2026. 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 Heather King, PhD, PMHNP-BC ((253) 254-5169, hking32@uthsc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insomnia Severity (time frame: Baseline, Six Weeks, Nine Weeks). 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 22 Oct 2026.