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

NCT05663034 | Recruiting DMC

• 2 other identifiers: IRB00356930141686
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 5

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).

Conditions

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

Keywords

Traumatic Brain Injury; Insomnia; Posttraumatic Stress Symptoms; Depression; Concussion; Head Injury; Brain Injury; Cognitive Behavioral Therapy for Insomnia; Mindfulness-based Treatment for Insomnia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Cognitive behavioral therapy for insomnia (CBT-I)

ACTIVE COMPARATOR

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.

Behavioral: Cognitive behavioral therapy for insomnia (CBT-I)

Mindfulness-based treatment for insomnia (MBTI)

ACTIVE COMPARATOR

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).

Behavioral: Mindfulness-based treatment for insomnia (MBTI)

Interventions

Mindfulness-based treatment for insomnia (MBTI) BEHAVIORAL

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

Mindfulness-based treatment for insomnia (MBTI)

Cognitive behavioral therapy for insomnia (CBT-I) BEHAVIORAL

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.

Cognitive behavioral therapy for insomnia (CBT-I)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead
• Department of Defense Congressionally Directed Medical Research Program: collaborator

Study Sites (5)

Intrepid Spirit Center - Eglin Air Force Base

Eglin Air Force Base, Florida, 32542, United States

RECRUITING

Naval School Explosive Ordance Disposal - Eglin Air Force Base

Eglin Air Force Base, Florida, 32542, United States

RECRUITING

Walter Reed National Medical Military Center

Bethesda, Maryland, 20814, United States

RECRUITING

Womack Army Medical Center

Fort Bragg, North Carolina, 28310, United States

RECRUITING

Madigan Army Medical Center

Fort Lewis, Washington, 98431, United States

RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic; Sleep Initiation and Maintenance Disorders; Depression; Memory Disorders; Brain Concussion; Craniocerebral Trauma; Brain Injuries

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Head Injuries, Closed; Wounds, Nonpenetrating

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Luis Buenaver, PhD

  Johns Hopkins School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luis Buenaver, PHD

CONTACT

4105507986; lbuenav1@jhmi.edu

Elizabeth Wysocki, MS

CONTACT

ewysock2@jhu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigators and outcome assessment technicians will remain blinded to treatment assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective two-arm, single blind randomized controlled trial

Study Record Dates

• First Submitted: December 14, 2022
• First Posted: December 23, 2022
• Study Start: May 10, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: December 18, 2025

Record last verified: 2025-12

Locations

US (5)