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| Name | Class |
|---|---|
| Naval Health Research Center | FED |
| United States Naval Medical Center, San Diego | FED |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| In-Person CBT-I | Experimental |
| |
| CBT-I via COAST | Experimental |
| |
| Treatment as Usual | No Intervention | Participants will receive only TBI-related interventions. No insomnia-specific interventions will be provided. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Insomnia Severity Index (ISI) | The Insomnia Severity Index is a 7-item self-report questionnaire that assesses subjective severity of insomnia symptoms, degree of satisfaction with sleep, nature and noticeability of daytime impairments, and concerns caused by sleep difficulties. Each item is rated on a 0 to 4-point scale. A cut-off score of 14 has been shown to optimize sensitivity and specificity. Scores from 0 to 7 reflect clinically insignificant insomnia; scores from 8 to 14 reflects subthreshold insomnia; scores from 15 to 21 reflect clinically significant insomnia of moderate severity; and scores from 22 to 28 reflect clinically significant, severe insomnia. Reductions of 6 or 8 points or more on the ISI reflect treatment response. | 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 |
| Rivermead Post-Concussion Questionnaire (RPCQ) | The Rivermead Post-Concussion Questionnaire will be used to examine post-concussive symptoms. It is a 16-item self-report questionnaire that assesses post-concussive symptoms in the physical, cognitive, and somatic domains. Each symptom is rated on a 5-point scale of 0 = not experienced at all to 4 = a severe problem. The questionnaire has demonstrated good reliability and consistency. It takes approximately 3 minutes to administer. It is recommended by the Department of Defense (DOD) and Department of Veterans affairs (VA) for traumatic brain injury (TBI) research and clinical evaluations. It was previously used as a measure of post-concussion symptoms in a prior trial of CBT-I in a TBI sample demonstrating moderate effects. | The Rivermead Post-Concussion Questionnaire will be administered at the baseline appointment, within 10 days post-intervention, and 3 month follow up appointment |
| Post-Traumatic Stress Disorder Checklist (PCL-5) | Post-Traumatic Stress Disorder Checklist (PCL-5) is a self-report questionnaire that includes 20 items that correspond to the four symptom clusters of PTSD. Each item is rated on a 5-point scale, ranging from 0 (Not at all) to 4 (Extremely). The sum of item scores rage from 0 to 80, with higher scores indicating more severe PTSD symptoms. It is used extensively in clinical practice and research investigating PTSD in military populations with good psychometric properties. It takes approximately 3 minutes to administer. |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep Diary | The sleep diary consists of a morning and evening log to assess sleep-wake patterns and daytime behavior that may comprise or facilitate sleep (e.g., naps, caffeine use, alcohol consumption, exercise, activation). The morning log is completed upon awakening in the morning and asks questions regarding the time at which the participant went to bed, attempted to fall asleep, duration of nocturnal awakenings, final time out of bed, and total estimated time spent asleep while in bed, and occurrence of disturbing dreams. Visual analog scales also prompt participants to estimate overall sleep quality and restorative quality. The evening portion of the log is completed before bedtime and asks questions about the preceding day including time of naps, exercise, and the consumption of caffeine, alcohol, and tobacco, (and practice of recommended behavioral modifications when applicable). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anne Germain, PhD | Contact | 4122123077 | anne@noctemhealth.com | |
| Anice Byrd | Contact | (760) 687-5448 | anice.m.byrd.ctr@health.mil |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Naval Medical Center San Diego | Recruiting | San Diego | California | 92134 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41630034 | Derived | Germain A, Wolfson M, Espejo E, Byrd A, Jurick S, Hungerford L, Sitzer T, Healy K, Chinoy E, Sessoms P, Wallace ML, MacGregor A. Behavioral treatment of insomnia in active-duty service members with traumatic brain injury: study protocol for a randomized clinical trial. Trials. 2026 Feb 2;27(1):185. doi: 10.1186/s13063-026-09483-z. |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| CBT-I via COAST | Behavioral | 6-week CBT-I delivered remotely via a clinician supervised digital platform by a doctoral-level clinician. |
|
| The Post-Traumatic Stress Disorder Checklist will be administered at the baseline appointment, within 10 days post-intervention, and 3-month follow up appointment. |
| Patient Health Questionnaire-8 items (PHQ-8) | Patient Health Questionnaire-8 items (PHQ-8) is the depression module of the self-administered version of the Primary Care Evaluation of Mental Disorders diagnostic instrument, the Patient Health Questionnaire (PHQ). The 8 items are based on the DSM-IV diagnostic criteria for depression. Each item is scored from 0 (not at all) to 3 (nearly every day), with higher score indicating greater depressive symptoms. It has demonstrated reliability and validity and takes approximately 3 minutes to administer. In addition, it has been widely adopted by the DOD and VA for research and clinical evaluation and is therefore highly suitable for the current study. | The Patient Health Questionnarie-8 items will be done at the baseline appointment, within 10 days post-intervention, and 3-month follow up appointment. |
| Generalized Anxiety Disorder Screen - 7-items (GAD-7) | Generalized Anxiety Disorder Screen - 7-items (GAD-7) is a self-report measure designed to assess severity of symptoms consistent with generalized anxiety disorder based on DSM-IV diagnostic criteria. Response options are "not at all," "several days," "more than half the days," and "nearly every day," scored as 0, 1, 2, and 3, respectively. Higher score indicate worse anxiety symptoms. The Generalized Anxiety Disorder Screen - 7 items has demonstrated adequate validity and reliability. It is a required instrument when sharing data with the NIMH Data Archive and has been widely adopted by the DOD and VA for research and clinical evaluation. | The Generalized Anxiety Disorder Screen 7-items will be completed at the baseline appointment, within 10 days post-intervention, and 3-month follow up appointment. |
| Participants will be instructed to complete the daily sleep logs for 1 week after the baseline appointment, every day during the 6-week acute intervention phase, and for 1-week before the 3-month follow up appointment |
| Brief Fatigue Inventory (BFI) | Brief Fatigue Inventory (BFI) is a self-report measure assessing fatigue levels and interference with functioning over the previous 24 hours. The nine items are rated from 0 (no fatigue) to 10 (as bad as you can imagine) and higher scores indicate worse fatigue. The measure has good psychometric properties and has demonstrated sensitivity to change in a pilot study of CBT-I in TBI patients. | The Brief Fatigue Inventory will be administered at the baseline appointment, each week during the 6-week acute intervention, within 10 days post-intervention, and 3 month follow up appointment |
| The World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) | The World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) is a 12-question, self-report questionnaire assessing general health and disability. The WHODAS 2.0 covers six domains: cognition, mobility, self-care, getting along with others, life activities, and participation. Items are rated from "None," "Mild," "Moderate," "Severe," to "Extreme or cannot do," indicating difficulty over the past month. Higher scores indicate greater disability. The WHODAS 2.0 has excellent psychometric properties. | The World Health Organization Disability Assessment Schedule 2.0 will be completed at the baseline appointment, within 10 days post-intervention, and 3-month follow up appointment |
| D001523 |
| Mental Disorders |
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |