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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.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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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
What is being tested?
Cognitive Behavioral Therapy for Insomnia
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.

Heather King, PhD, PMHNP-BC contact

(253) 254-5169

hking32@uthsc.edu

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.
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 groups in NCT07335276
Study groupRoleWhat they receive
Digital App CBTIExperimentalParticipants will use a digital app for self-directed CBTI for five weeks.
Receives: Behavioral: Cognitive Behavioral Therapy for Insomnia
Waitlist ControlNo interventionThis 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.

  1. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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.

  1. First posted13 Jan 2026
  2. Study start1 Nov 2026 (estimated)
  3. Primary completion2 Oct 2027 (estimated)
  4. Study completion2 Oct 2028 (estimated)

Resources

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)
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.

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.

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