Behavioral Treatment for Insomnia in Active-Duty Service Members with Traumatic Brain Injury
This study is looking at ways to improve sleep for active-duty Sailors who have both insomnia (trouble sleeping) and a history of traumatic brain injury (TBI). Researchers are comparing two types of Cognitive Behavioral Therapy for Insomnia (CBT-I) to usual care. One CBT-I approach is delivered in person or through telehealth by a clinician. The other CBT-I approach uses a digital platform called COAST, also supervised by a clinician. The goal is to see how these CBT-I methods affect not only insomnia, but also symptoms like post-concussion issues and psychological well-being. The study aims to enroll 168 participants, but its current recruitment status is unclear.
- Study design
- This is an interventional, randomized controlled trial comparing two CBT-I interventions to usual care, with a planned enrollment of 168 participants.
- What's involved
- Participants will have appointments at baseline, during treatment weeks 2, 4, and 6, within 10 days after treatment, and at a 3-month follow-up.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 3 months after the intervention.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Behavioral Treatment of Insomnia in Active-Duty Service Members With Traumatic Brain Injury
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Insomnia Severity Index (ISI)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
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.
- Rivermead Post-Concussion Questionnaire (RPCQ)The Rivermead Post-Concussion Questionnaire will be administered at the baseline appointment, within 10 days post-intervention, and 3 month follow up appointment
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.
- Post-Traumatic Stress Disorder Checklist (PCL-5)The Post-Traumatic Stress Disorder Checklist 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) 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.
- Patient Health Questionnaire-8 items (PHQ-8)The Patient Health Questionnarie-8 items will be done at the baseline appointment, within 10 days post-intervention, and 3-month follow up appointment.
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.
- Generalized Anxiety Disorder Screen - 7-items (GAD-7)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.
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.