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RECRUITING
NCT06867666
NA

Behavioral Treatment of Insomnia in Active-Duty Service Members With Traumatic Brain Injury

Sponsor: Noctem, LLC

View on ClinicalTrials.gov

Summary

The objective of the study is to conduct a randomized controlled trial of Cognitive Behavioral Therapy for Insomnia (CBT-I) in a sample of active-duty sailors with a history of traumatic brain injury (TBI). The investigators will test the impact of CBT-I on insomnia symptoms as well as post-concussive symptoms, psychological symptoms, and neurocognitive functioning in comparison to treatment as usual. The investigators will also compare the effectiveness of traditional in-person CBT-I and CBT-I delivered via a clinician-supervised digital health platform, Clinician Operated Assistive Sleep Technology (COAST) in comparison to treatment as usual on symptoms of insomnia, post-concussive symptoms, neurocognitive functioning, and psychological health. Participants will be assessed at baseline, post-treatment, and 3 months later.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

168

Start Date

2025-04-01

Completion Date

2027-01-31

Last Updated

2025-04-24

Healthy Volunteers

No

Interventions

BEHAVIORAL

In Person CBT-I

6-week CBT-I delivered in-person at the TBI Clinic at NMCSD or via telehealth on a secure, Health Insurance Portability and Accountability Act (HIPAA) compliant platform by a doctoral-level clinician.

BEHAVIORAL

CBT-I via COAST

6-week CBT-I delivered remotely via a clinician supervised digital platform by a doctoral-level clinician.

Locations (1)

Naval Medical Center San Diego

San Diego, California, United States