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Clinical Trial NCT05663034 for Traumatic Brain Injury, Insomnia, Depression, Post-traumatic Stress, Sleep, Memory Impairment, Cognitive Behavioral Therapy, Concussion, Brain, Head Injury, Brain Injury Traumatic Mild is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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CBT-I vs. MBTI for Traumatic Brain Injury (TBI)-Related Insomnia and Post-Traumatic Stress Symptoms

Recruiting
Clinical Trial NCT05663034 is an interventional study for Traumatic Brain Injury, Insomnia, Depression, Post-traumatic Stress, Sleep, Memory Impairment, Cognitive Behavioral Therapy, Concussion, Brain, Head Injury, Brain Injury Traumatic Mild that is recruiting. It started on May 10, 2024 with plans to enroll 360 participants. Led by Johns Hopkins University, it is expected to complete by September 1, 2026. The latest data from ClinicalTrials.gov was last updated on December 24, 2024.
Brief 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).
Official Title

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

Conditions
Traumatic Brain InjuryInsomniaDepressionPost-traumatic StressSleepMemory ImpairmentCognitive Behavioral TherapyConcussion, BrainHead InjuryBrain Injury Traumatic Mild
Other Study IDs
  • IRB00356930
  • 141686 (Other Grant/Funding Number) (Department of Defense Congressionally Directed Medical Research Program)
NCT ID Number
NCT05663034
Start Date (Actual)
2024-05-10
Last Update Posted
2024-12-24
Completion Date (Estimated)
2026-09
Enrollment (Estimated)
360
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
Traumatic Brain Injury
Insomnia
Posttraumatic Stress Symptoms
Depression
Concussion
Head Injury
Brain Injury
Cognitive Behavioral Therapy for Insomnia
Mindfulness-based Treatment for Insomnia
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Double
Arms / Interventions
Participant Group/ArmIntervention/Treatment
Active ComparatorCognitive behavioral therapy for insomnia (CBT-I)
CBT-I treatment will involve a standardized 6-session blended intervention that combines cognitive and behavioral techniques. The core components include (1) education about sleep and insomnia, stimulus control (SC) and sleep restriction (SRT) (week 1); (2) sleep hygiene education (week 2); and (3) relaxation training, cognitive restructuring (to counter-arousal and address sleep-interfering cognitions), adherence monitoring, and adjusting the recommended sleep-wake schedule (weeks 3 through 6). The final session will also include a review of treatment content and relapse prevention. Common to all sessions is an initial review of participant diary data, charting progress, setting measurable goals, discussing adherence, and reinforcing learned skills.
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.
Active ComparatorMindfulness-based treatment for insomnia (MBTI)
MBTI treatment will involve a standardized 6-session intervention which integrates the mindfulness training and exercises from mindfulness-based stress reduction (MBSR) with behavioral strategies based on sleep restriction therapy and stimulus control delivered within the context of mindfulness principles. Mindfulness principles include: 1) increase awareness of the mental and physical states that promote sleep (i.e., sleepiness), 2) shift sleep-related metacognitions to reduce hyperarousal, and 3) promote a mindful stance to respond when symptoms of insomnia arise. An overview of the treatment program, sleep education, and an introduction to the principles of mindfulness meditation is given (week 1). Then a combination of mindfulness meditations, sleep restriction, and stimulus control is conducted (week 2-6).
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
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Change in Insomnia severity as assessed by the insomnia severity index (ISI)
Insomnia symptoms and severity measured by insomnia severity index (ISI); score range: 0-28; Higher scores are associated with greater insomnia symptoms
At the end of treatment, and 2-, 6- and 12-weeks post treatment
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  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.

  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.
Johns Hopkins University logoJohns Hopkins University587 active trials to explore
Department of Defense Congressionally Directed Medical Research Program logoDepartment of Defense Congressionally Directed Medical Research Program
Study Central Contact
Contact: Luis Buenaver, PHD, 4105507986, [email protected]
Contact: Elizabeth Wysocki, MS, [email protected]
5 Study Locations in 1 Countries

Florida

Intrepid Spirit Center - Eglin Air Force Base, Eglin Air Force Base, Florida, 32542, United States
Mary Fergus, Contact, 240-204-1573
Recruiting
Naval School Explosive Ordance Disposal - Eglin Air Force Base, Eglin Air Force Base, Florida, 32542, United States
Mary Fergus, Contact, 240-204-1573
Recruiting

Maryland

Walter Reed National Medical Military Center, Bethesda, Maryland, 20814, United States
Seyi Gbade-Alabi, Contact, 301-550-0350
Recruiting

North Carolina

Womack Army Medical Center, Fort Bragg, North Carolina, 28310, United States
Katherine Dermers, Contact, 301-550-0352
Recruiting

Washington

Madigan Army Medical Center, Fort Lewis, Washington, 98431, United States
Rachel Satter, Contact, 301-550-0353
Recruiting