Cognitive Behavioral Therapy for Insomnia
(CBTBI Trial)

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Noctem, LLC

No Placebo Group

Trial Summary

What is the purpose of this trial?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 Criteria

This trial is for active-duty sailors who have experienced a traumatic brain injury (TBI) and are struggling with insomnia. Participants should be currently serving, have a history of TBI, and suffer from sleep problems. Details on specific inclusion or exclusion criteria were not provided.

Inclusion Criteria

Active duty Sailors and activated Reservist Sailors

History of TBI confirmed by study evaluators

Own a smart device for using the COAST app

+3 more

Exclusion Criteria

Inability to comprehend or read English

Serious mental health diagnosis such as bipolar disorder or psychosis, or seizure disorder

Potential alcohol use disorder

+4 more

Participant Groups

The study compares Cognitive Behavioral Therapy for Insomnia (CBT-I) delivered in person versus through a digital platform called COAST against usual treatment. It aims to see how each method affects sleep issues, post-concussive symptoms, thinking abilities, and mental health.

3Treatment groups

Experimental Treatment

Active Control

Group I: In-Person CBT-IExperimental Treatment1 Intervention

Group II: CBT-I via COASTExperimental Treatment1 Intervention

Group III: Treatment as UsualActive Control1 Intervention

Participants will receive only TBI-related interventions. No insomnia-specific interventions will be provided.