NCT07385105

Evaluation of Cognitive Behavioral Therapy for Insomnia (CBT-I) in Individuals With Mild Traumatic Brain Injury (mTBI)

Exploring Cognitive Behavioral Therapy for Insomnia (CBT-I) in Mild Traumatic Brain Injury (mTBI)

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: University of Missouri-Columbia · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

This study will employ cognitive behavioral therapy for insomnia (CBT-I) among individuals with mild traumatic brain injury (mTBI) who experience sleep disturbances. The research aims to evaluate the effects of CBT-I on sleep, mTBI symptoms, and, in particular, the ability of individuals with mTBI to engage in their desired daily life activities. The main questions this study aims to answer are: 1. Does CBT-I positively impact symptoms of mTBI? 2. Does CBT-I improve functional performance in individuals with mTBI?

Detailed description

Cognitive behavioral therapy for insomnia (CBT-I) is an evidence-based intervention that has demonstrated significant results in various populations. CBT-I is a structured and goal-oriented approach that addresses both unhelpful thoughts and maladaptive behaviors contributing to poor sleep. CBT-I includes several components, such as behavioral strategies that aim to change habits disrupting sleep architecture and cognitive techniques targeting maladaptive beliefs about sleep. However, limited research has examined the use of this intervention among individuals with mild traumatic brain injury (mTBI), particularly regarding its impact on their ability to perform daily life activities. This study aims to evaluate how CBT-I can impact sleep, mTBI symptoms, and participants' functional performance.

Conditions

• Sleep Architecture
• Mild Traumatic Brain Injury
• Sleep
• Sleep and Circadian Problems

Interventions

Type	Name	Description
BEHAVIORAL	Cognitive behavioral Therapy for insomnia (CBT-I)	CBT-I is an evidence-based psychotherapy designed to address insomnia. This structured and multifaceted intervention aims to help individuals who have trouble falling asleep or/ and staying asleep during the night. CBT-I is a multi-component treatment that includes two core parts: behavioral and cognitive aspects. It consists of Sleep Restriction Therapy (SRT), Stimulus Control Therapy (SCT), and Cognitive Therapy (CT) with an emphasis on Cognitive restructuring, as well as Psychoeducation and Sleep Hygiene Education. Each CBT-I session has a clear structure and includes various components such as assessment, psychoeducation, behavioral and cognitive interventions, adherence monitoring, and strategies for preventing relapse. In this study, participants will receive CBT-I in a one-on-one setting, meeting on Zoom once a week for six weeks, and each session will last an hour.

Timeline

• Start date: 2026-03-01
• Primary completion: 2026-09-30
• Completion: 2027-01-01
• First posted: 2026-02-03
• Last updated: 2026-02-18

Locations

1 site across 1 country: United States