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Not Yet Recruiting NCT07886398

Sleep MAPP in the Polytrauma/TBI System of Care

Conditions: Insomnia Disorder, Mild Traumatic Brain Injury

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 900
Sponsor: VA Office of Research and Development

Location: Rocky Mountain Regional VA Medical Center, Aurora, CO Aurora Colorado

Summary

This pilot implementation trial will evaluate the Sleep Disorder Management Assistance for Providers and Patients (Sleep MAPP) Care Pathway in one Veterans Health Administration Polytrauma/TBI System of Care clinic. The care pathway combines a provider-facing decision-support tool that supports pre-visit administration and documentation of the Insomnia Severity Index with training and implementation support for clinic providers to deliver Brief Behavioral Therapy for Insomnia. The study will assess the feasibility and acceptability of the care pathway; describe changes in guideline-concordant insomnia screening and behavioral treatment; and describe preliminary changes in insomnia symptoms, neurobehavioral symptoms, and participation in social roles among Veterans with mild traumatic brain injury who receive Brief Behavioral Therapy for Insomnia. Up to 30 clinic providers or staff and 50 Veterans will be invited to complete research surveys and interviews. Implementation and clinical outcomes will be obtained from routinely collected clinical data.

Eligibility Criteria

Inclusion Criteria: Aim 1 Provider participants (study procedures aimed at understanding feasibility and acceptability) \- Multidisciplinary member of the Polytrauma Network Site who is involved in implementation of the Sleep MAPP Care Pathway (e.g., program leadership, referring clinicians, and clinicians eligible for Brief Behavioral Therapy for Insomnia training). Aim 1 Veteran participants (study procedures aimed at understanding feasibility and acceptability) * Clinician-confirmed mild traumatic brain injury documented in the Comprehensive TBI Evaluation Database. * Received the Insomnia Severity Index. * Initiated Brief Behavioral Therapy for Insomnia at the Polytrauma Network Site and completed Brief Behavioral Therapy for Insomnia no more than 1 week before being invited to participate. Aim 2 Provider participants (study procedures aimed at understanding reach, adoption, implementation, and maintenance) \- Multidisciplinary member of the Polytrauma Network Site who is involved in implementation of the Sleep MAPP Care Pathway, including referring clinicians and clinicians eligible for Brief Behavioral Therapy for Insomnia training. Aim 2 Veteran participants (study procedures aimed at understanding reach, adoption, implementation, and maintenance) * History of mild traumatic brain injury, diagnosed during routine clinical care. * Scheduled to receive care at the Polytrauma Network Site. Aim 3 Veteran participants (study procedures aimed at understanding change in clinical outcomes after Brief Behavioral Therapy for Insomnia delivery) * History of mild traumatic brain injury, diagnosed during routine clinical care. * Insomnia Severity Index score of 11 or higher. Exclusion Criteria: Does not meet all inclusion criteria.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07886398). StuddyBuddy aggregates publicly available trial information.