NCT06867666

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 168 (estimated)
• Sponsor: Noctem, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Insomnia
• TBI (Traumatic Brain Injury)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-04-01
• Primary completion: 2027-01-31
• Completion: 2027-01-31
• First posted: 2025-03-10
• Last updated: 2025-04-24

Locations

1 site across 1 country: United States