NCT07335276

Brief 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. 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?

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
144

participants targeted

Target at P75+ for not_applicable

Timeline
30mo left

Started Mar 2026

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress7%
Mar 2026Oct 2028

First Submitted

Initial submission to the registry

January 5, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 13, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 2, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 2, 2028

Last Updated

January 22, 2026

Status Verified

January 1, 2026

Enrollment Period

1.6 years

First QC Date

January 5, 2026

Last Update Submit

January 20, 2026

Conditions

Depression - Major Depressive DisorderInsomniaPTSD

Keywords

InsomniaService MembersCognitive Behavioral Therapy for InsomniaDigital Application

Outcome Measures

Primary Outcomes (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).

    Baseline, Six Weeks, Nine Weeks

Secondary Outcomes (5)

  • Consensus Sleep Diary

    Baseline, Six Weeks

  • PROMIS Sleep-Related Impairment 8a

    Baseline, Six Weeks, Nine Weeks

  • The Post Traumatic Stress Disorder Checklist-Military Version (PCL-M)

    Baseline, Six Weeks, Ten Weeks

  • The Patient Health Questionnaire-8 (PHQ-8)

    Baseline, Six Weeks, Nine Weeks

  • RAND-36 Item Short Form Survey

    Baseline, Six Weeks, Ten Weeks

Study Arms (2)

Digital App CBTI

EXPERIMENTAL

Participants will use a digital app for self-directed CBTI for five weeks.

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.

Interventions

Cognitive Behavioral Therapy for InsomniaBEHAVIORAL

This intervention will be delivered via a smart phone app

Digital App CBTI

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Active Duty, Reservist, Army National Guard
  • Ages 18-55 years
  • Own a smart phone
  • Internet access

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Sleep Initiation and Maintenance DisordersStress Disorders, Post-Traumatic

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental DisordersStress Disorders, TraumaticTrauma and Stressor Related Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Central Study Contacts

Heather King, PhD, PMHNP-BC

CONTACT

(253) 254-5169hking32@uthsc.edu

Christine Snyder, PhD

CONTACT

(253) 968-2465christine.m.snyder30.civ@health.mil

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
All study participants will complete initial study questionnaires and sleep diary data for one week. At one week study participants will be randomized into groups. At this time the study will be unblinded to provide instructions on the intervention and to follow up with participants for questionnaire completion.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Study design is a prospective, randomized controlled trial with two arms (intervention and wait list control).
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2026

First Posted

January 13, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

October 2, 2027

Study Completion (Estimated)

October 2, 2028

Last Updated

January 22, 2026

Record last verified: 2026-01