CBT-I vs. MBTI for Traumatic Brain Injury (TBI)-Related Insomnia and Post-Traumatic Stress Symptoms
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Mindfulness-based treatment for insomnia (MBTI), Cognitive behavioral therapy for insomnia (CBT-I).
- Who it may be relevant to
- Registry conditions: Traumatic Brain Injury, Insomnia, Depression, Post-traumatic Stress. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
CoMBat Insomnia: A Randomized Controlled Trial of Cognitive-Behavioral vs. Mindfulness-Based Treatment for TBI-Related Insomnia and Post-Traumatic Stress Symptoms
Overview
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).
Interventions
- 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.
Primary outcome measures
- Change in Insomnia severity as assessed by the insomnia severity index (ISI) [Time frame: At the end of treatment, and 2-, 6- and 12-weeks post treatment]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 5 centers
- Intrepid Spirit Center - Eglin Air Force Base — Eglin Air Force Base
- Naval School Explosive Ordance Disposal - Eglin Air Force Base — Eglin Air Force Base
- Walter Reed National Medical Military Center — Bethesda
- Womack Army Medical Center — Fort Bragg
- Madigan Army Medical Center — Fort Lewis
Identifiers
NCT: NCT05663034 · IRB00356930 · 141686