RecruitingNot ApplicableNCT05663034

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

Sponsor

Johns Hopkins University

Enrollment

360 participants

Start Date

May 10, 2024

Study Type

INTERVENTIONAL

Conditions

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

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).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study compares two types of behavioral therapy for sleep problems (insomnia) and post-traumatic stress symptoms in military veterans who have also suffered a traumatic brain injury (TBI): Cognitive Behavioral Therapy for Insomnia (CBT-I) versus Mindfulness-Based Therapy for Insomnia (MBTI). **You may be eligible if...** - You are a current or former member of the U.S. military (uniform services) - You have been diagnosed with a traumatic brain injury (TBI) more than 90 days ago - You have had insomnia symptoms for more than 90 days - Your insomnia score is above 10 on the Insomnia Severity Index - You are 18 or older - You have access to a computer and can use it comfortably - You have sufficient cognitive ability to give informed consent **You may NOT be eligible if...** - You have a neurological condition other than TBI - You have moderate to severe sleep apnea (more than 15 events per hour) that is untreated - Your psychiatric medications have been changed in the past 3 weeks Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BEHAVIORALMindfulness-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

BEHAVIORALCognitive 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.