NCT05663034

CBT-I vs. MBTI for Traumatic Brain Injury (TBI)-Related Insomnia and Post-Traumatic Stress Symptoms

CoMBat Insomnia: A Randomized Controlled Trial of Cognitive-Behavioral vs. Mindfulness-Based Treatment for TBI-Related Insomnia and Post-Traumatic Stress Symptoms

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 360 (estimated)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a prospective two-arm, single blind randomized controlled trial design to compare the clinical effectiveness of telemedicine-delivered, 6-session, standardized cognitive behavioral therapy for insomnia (CBT-I) and mindfulness-based treatment for insomnia (MBTI) in treating insomnia symptoms and ameliorating depressive symptoms in persons with mild to moderate TBI and comorbid Post-Traumatic Stress Symptoms (PTSS) and insomnia symptoms in a 360 patients. Participants will undergo assessment (psychosocial questionnaires, neurocognitive testing, sleep monitoring) at baseline, at the end of treatment, and at 2-, 6- and 12-weeks post-treatment. The primary outcome is sleep as measured by the Insomnia Severity Index (ISI).

Detailed description

This study is a prospective two-arm, randomized single blind controlled trial design to compare the clinical effectiveness of telemedicine-delivered cognitive behavioral therapy for insomnia (CBT-I) and mindfulness-based treatment for insomnia (MBTI) in treating insomnia and ameliorating depressive symptoms in persons with mild to moderate TBI and comorbid symptoms of posttraumatic stress and insomnia. A cohort of n=360 adults with mild to moderate TBI and comorbid symptoms of posttraumatic stress and insomnia will be randomized to receive either telemedicine-delivered CBT-I or MBTI. Consistent with previous scientific literature, the interventions will be standardized and six sessions in length. All participants will wear an actigraph wrist monitor throughout the course of the project. All participants will also complete electronic sleep diaries throughout the course of the project. Participants will undergo assessment (psychosocial questionnaires, neurocognitive testing, sleep diaries, actigraphy, ambulatory EEG sleep monitoring) at baseline, at the end of treatment, and at 2-, 6- and 12-weeks post-treatment (12- and 24-weeks post randomization, respectively). The primary outcome is insomnia severity (ISI) and secondary outcomes are pre-sleep arousal, and depressive symptoms (PSAS; Patient Health Questionnaire (PHQ-8). Exploratory analyses will include neurocognitive functioning (ANAM) and pre-sleep arousal (PSAS).

Conditions

• Traumatic Brain Injury
• Insomnia
• Depression
• Post-traumatic Stress
• Sleep
• Memory Impairment
• Cognitive Behavioral Therapy
• Concussion, Brain
• Head Injury
• Brain Injury Traumatic Mild

Interventions

Type	Name	Description
BEHAVIORAL	Mindfulness-based treatment for insomnia (MBTI)	A 6-week intervention that uses the principles and practices of mindfulness meditation along with behavioral strategies (stimulus control, sleep restriction therapy) to reduce symptoms of insomnia
BEHAVIORAL	Cognitive behavioral therapy for insomnia (CBT-I)	Standard of care for adults with chronic insomnia. 6-week program that uses behavioral techniques to decrease psychophysiological arousal and increase sleep propensity to deepen and consolidate sleep.

Timeline

• Start date: 2024-05-10
• Primary completion: 2026-05-01
• Completion: 2026-09-01
• First posted: 2022-12-23
• Last updated: 2025-12-18

Locations

5 sites across 1 country: United States