Behavioral treatment of insomnia in active-duty service members with traumatic brain injury: study protocol for a randomized clinical trial.
Anne Germain, Megan Wolfson, Emmanuel Espejo...
https://pubmed.ncbi.nlm.nih.gov/41630034Actively Recruiting
Led by Noctem, LLC · Updated on 2025-04-24
168
Participants Needed
1
Research Sites
N/A
Total Duration
N
Noctem, LLC
Lead Sponsor
N
Naval Health Research Center
Collaborating Sponsor
Researchers are evaluating Cognitive Behavioral Therapy for Insomnia (CBT-I) in active-duty sailors who have experienced traumatic brain injury (TBI). The study aims to compare the effects of traditional in-person CBT-I and CBT-I delivered through a digital health platform called Clinician Operated Assistive Sleep Technology (COAST) against usual treatment on symptoms of insomnia, post-concussive effects, psychological health, and brain function. Participants will be assessed before treatment, after treatment, and three months later to understand the therapies' impacts. The study involves three groups: one receiving in-person CBT-I at a TBI clinic or via telehealth, another receiving CBT-I remotely through the COAST digital platform, and a third group receiving treatment as usual without insomnia-specific care. Both CBT-I interventions last six weeks and are delivered by doctoral-level clinicians. Participants in all groups will use the COAST app to complete daily sleep logs and assessments throughout the study. Participants will attend baseline and follow-up appointments where various questionnaires and inventories will be completed to measure insomnia severity, post-concussion symptoms, psychological conditions like PTSD, depression, anxiety, fatigue, and disability. Sleep diaries will be kept daily during the intervention and for one week before the follow-up visit. Medication use and sleep apnea therapy stability will be monitored, and assessments will occur at multiple time points including baseline, mid-treatment, post-treatment, and three months after treatment ends. The total participation duration spans from initial evaluation through the 3-month follow-up.
CONDITIONS
Behavioral Treatment of Insomnia in Active-Duty Service Members With Traumatic Brain Injury
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 6 weeks
Participants receive 6 weeks of cognitive behavioral therapy for insomnia (CBT-I) either in-person or remotely via a digital platform, led by a doctoral-level clinician.
Weekly visits during the 6-week treatment period
Duration - 3 months post-treatment
Participants are followed up to assess insomnia severity and other health outcomes after completing treatment.
1 follow-up visit at 3 months post-treatment
Total: 1 location
1
Naval Medical Center San Diego
San Diego, California, United States, 92134
Actively Recruiting
A
Anne Germain, PhD
A
Anice Byrd
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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Anne Germain, Megan Wolfson, Emmanuel Espejo...
https://pubmed.ncbi.nlm.nih.gov/41630034