RecruitingNot ApplicableNCT06867666

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


Sponsor

Noctem, LLC

Enrollment

168 participants

Start Date

Apr 1, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a behavioral approach called CBT-I via COAST and a behavioral approach called In Person CBT-I for people with insomnia and tbi (traumatic brain injury). The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALIn 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.

BEHAVIORALCBT-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

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NCT06867666


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