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

Launched by JOHNS HOPKINS UNIVERSITY · Dec 22, 2022

Keywords

ClinConnect Summary

This clinical trial is investigating two different treatments for people with mild to moderate traumatic brain injury (TBI) who are experiencing insomnia and post-traumatic stress symptoms (PTSS). The study compares cognitive behavioral therapy for insomnia (CBT-I), which is a structured program that helps improve sleep patterns, with mindfulness-based treatment for insomnia (MBTI), which focuses on relaxation and being present in the moment. The goal is to see which treatment works better in helping participants sleep better and feel less depressed.

To take part in the trial, you need to be at least 18 years old, a current or former member of the uniformed services, and have had insomnia for more than 90 days since your TBI, which must have occurred more than 90 days ago. Participants will complete surveys and sleep evaluations before, during, and after the treatment to track their progress. The study is currently recruiting participants, and if you're eligible, you'll receive six sessions of therapy delivered through telemedicine, making it convenient to participate from home.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Current or former member of the uniform services
• • 2. Meet the Veterans Affairs Medical Center (VAMC) Department of Defense (DoD) criteria for TBI;
• • 3. Time duration since traumatic brain injury (TBI) injury \>90 days
• • 4. Insomnia symptom duration \>90 days
• • 5. Endorse insomnia symptoms (Insomnia Severity Index \[ISI\] score \> 10)
• • 6. Display sufficient cognitive capacity to provide informed consent (Montreal Cognitive Assessment (MoCA) Z-score \> -2)
• • 7. \>18 years of age
• • 8. Access to and ability and to use computer.
• Exclusion Criteria:
• • 1. History of neurological diseases other than TBI and not attributable to TBI
• • 2. Sleep apnea \[apnea hypopnea index (AHI) \>15; individuals with mild apnea (AHI \> 5 and \<15) will be informed, but allowed to participate\]. Participants who use a continuous positive airway pressure (CPAP) device for sleep apnea will be eligible for participation if they are below the apnea/hypopnea cutoff while using CPAP, are adherent to using the device (\> 4 hours/night 21/30 consecutive days) and agree to continue using the device during study participation.
• • 3. Lastly, people using psychotropic medications may be included if they are on a stable dosage for the last three weeks prior to the study.