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

Madigan Army Medical Center

Status: Begins enrollment this month

Conditions: PTSD; Insomnia; Depression - Major Depressive Disorder

Treatments: Behavioral: Cognitive Behavioral Therapy for Insomnia

Study type: Interventional

Funder types: Other U.S. Federal agency; Other

Identifiers

NCT07335276

11207-N25-D03

Details and patient eligibility

About

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?

Full 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.

Enrollment: 144 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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144 participants in 2 patient groups

Digital App CBTI

Experimental group

Description:

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

Treatment:

Behavioral: Cognitive Behavioral Therapy for Insomnia

Waitlist Control

No Intervention group

Description:

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