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

NCT ID: NCT05663034

Last Updated: 2024-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-10

Study Completion Date

2026-09-30

Brief Summary

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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

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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).

Conditions

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

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective two-arm, single blind randomized controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
Investigators and outcome assessment technicians will remain blinded to treatment assignment.

Study Groups

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Cognitive 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.

Group Type ACTIVE_COMPARATOR

Cognitive behavioral therapy for insomnia (CBT-I)

Intervention Type 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.

Mindfulness-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).

Group Type ACTIVE_COMPARATOR

Mindfulness-based treatment for insomnia (MBTI)

Intervention Type 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

Interventions

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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

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Department of Defense Congressionally Directed Medical Research Program

UNKNOWN

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Luis Buenaver, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins School of Medicine

Locations

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Intrepid Spirit Center - Eglin Air Force Base

Eglin Air Force Base, Florida, United States

Site Status RECRUITING

Naval School Explosive Ordance Disposal - Eglin Air Force Base

Eglin Air Force Base, Florida, United States

Site Status RECRUITING

Walter Reed National Medical Military Center

Bethesda, Maryland, United States

Site Status RECRUITING

Womack Army Medical Center

Fort Bragg, North Carolina, United States

Site Status RECRUITING

Madigan Army Medical Center

Fort Lewis, Washington, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Luis Buenaver, PHD

Role: CONTACT

Phone: 4105507986

Email: [email protected]

Elizabeth Wysocki, MS

Role: CONTACT

Email: [email protected]

Facility Contacts

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Mary Fergus

Role: primary

Mary Fergus

Role: primary

Seyi Gbade-Alabi

Role: primary

Katherine Dermers

Role: primary

Rachel Satter

Role: primary

Other Identifiers

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141686

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IRB00356930

Identifier Type: -

Identifier Source: org_study_id