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

Inclusion Criteria8

Current or former member of the uniform services
Meet the Veterans Affairs Medical Center (VAMC) Department of Defense (DoD) criteria for TBI;
Time duration since traumatic brain injury (TBI) injury \>90 days
Insomnia symptom duration \>90 days
Endorse insomnia symptoms (Insomnia Severity Index \[ISI\] score \> 10)
Display sufficient cognitive capacity to provide informed consent (Montreal Cognitive Assessment (MoCA) Z-score \> -2)
\>18 years of age
Access to and ability and to use computer.

Exclusion Criteria3

History of neurological diseases other than TBI and not attributable to TBI
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.
Lastly, people using psychotropic medications may be included if they are on a stable dosage for the last three weeks prior to the study.

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.