NCT06551987

Behavioral Insomnia Treatment in Mild Traumatic Brain Injury

Cognitive Behavioral Therapy for Insomnia vs Brief Behavioral Therapy for Insomnia in Military Personnel With Postconcussive Symptoms Following Mild Traumatic Brain Injury

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: The University of Texas Health Science Center at San Antonio · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

This is a single site, two-armed random controlled trials (RCT) comparing six sessions of Cognitive Behavioral Therapy for Insomnia (CBT-I) with four sessions of Brief Behavioral Therapy for Insomnia (BBT-I) in service members with comorbid insomnia and prolonged postconcussive symptoms present for at least 3 months after Mild Traumatic Brain Injury (mTBI).

Detailed description

The purpose of this study is to identify the optimal behavioral treatment for insomnia in service members with comorbid insomnia and prolonged postconcussive symptoms following Mild Traumatic Brain Injury (mTBI). The study will compare Cognitive Behavioral Therapy for Insomnia (CBT-I) and Brief Behavioral Therapy for Insomnia (BBT-I) and determine the impact of behavioral insomnia treatment on insomnia symptom severity. This study will explore the impact of insomnia treatment on prolonged postconcussive symptoms and blood-based biomarkers. The overall objective is to determine if behavioral insomnia therapy can improve outcomes in service members with prolonged postconcussive symptoms following mTBI. Both in-person and telehealth treatment formats will be offered to adapt to the service members schedule. The minimum acceptable number of sessions to the interventions in order to have evaluable data will be 4 sessions for CBT-I and 3 sessions for BBT-I. A participant is considered to have completed the study if he or she has completed the baseline assessment, at least 4 sessions for CBT-I and 3 sessions for BBT-I, and the 7-week and 12-week follow-up assessments. Participants will be seen and treated at the Intrepid Spirit Center and/or the STRONG STAR offices both part of the Carl R. Darnall Army Medical Center (CRDAMC) located on the Fort Cavazos. Active duty service members at least 18 years of age who are seeking clinical care for persisting mTBI symptoms at the Intrepid Spirit Center located on Fort Cavazos. Women will be actively recruited into the study.

Conditions

• Insomnia
• Mild Traumatic Brain Injury

Interventions

Type	Name	Description
BEHAVIORAL	Cognitive Behavioral Therapy for Insomnia	6 weekly, 50-minute sessions delivered individually using in-person or telehealth format by a trained behavioral health provider.
BEHAVIORAL	Brief Behavioral Therapy for Insomnia	4 weekly, 30-minute sessions delivered individually using in-person or telehealth format by a trained behavioral health provider.

Timeline

• Start date: 2024-12-03
• Primary completion: 2027-02-01
• Completion: 2027-09-01
• First posted: 2024-08-13
• Last updated: 2026-01-07

Locations

1 site across 1 country: United States