Enhancing Operational Readiness With Digital Self-Managed Cognitive Behavioral Therapy for Insomnia (CBTI)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-03-01

Study Completion Date

2028-10-02

Brief Summary

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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?

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Detailed Description

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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

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Insomnia Depression - Major Depressive Disorder PTSD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Study design is a prospective, randomized controlled trial with two arms (intervention and wait list control).

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

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.

Study Groups

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Digital App CBTI

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

Group Type EXPERIMENTAL

Cognitive Behavioral Therapy for Insomnia

Intervention Type BEHAVIORAL

This intervention will be delivered via a smart phone app

Waitlist Control

This group will be placed on a waitlist control group until the follow up period is complete.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Cognitive Behavioral Therapy for Insomnia

This intervention will be delivered via a smart phone app

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No