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

Part of paid clinical trials in San Diego, California.

Sponsor
Noctem, LLC
Study ID
NCT06867666
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • In Person CBT-I — BEHAVIORAL
    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.
  • CBT-I via COAST — BEHAVIORAL
    6-week CBT-I delivered remotely via a clinician supervised digital platform by a doctoral-level clinician.

Study Details

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 Dates

Start date
Apr 1, 2025
Status verified
Apr 2025
Primary completion
Jan 31, 2027
Completion
Jan 31, 2027

Study Design

Enrollment
168 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: In-Person CBT-I
  • Experimental: CBT-I via COAST
  • No Intervention: Treatment as Usual
    Participants will receive only TBI-related interventions. No insomnia-specific interventions will be provided.

Primary Outcome Measure

Insomnia Severity Index (ISI) [ Time Frame: The Insomnia Severity Index (ISI) will be administered at the baseline appointment, treatment weeks 2, 4, and 6, within 10 days post-intervention, and the 3-month follow-up to measure insomnia symptoms severity ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Naval Medical Center San DiegoSan DiegoCalifornia92134
Anice Byrd Research Coordinator
[email protected]
7606875448

Find similar trials in San Diego, CA

By condition
Insomnia
By specialty
Mental healthSleep medicine
By research site
Naval Medical Center San Diego· San Diego, CA

Related Studies