Recruiting

CBT-I vs. MBTI

Sponsor:

Johns Hopkins University

Code:

NCT05663034

Conditions

Traumatic Brain Injury

Insomnia

Depression

Post-traumatic Stress

Sleep

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Mindfulness-based treatment for insomnia (MBTI)

Cognitive behavioral therapy for insomnia (CBT-I)

Study Details

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

Study ID

NCT05663034

Start date

May 10, 2024

Status verified date

Jul, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

360 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: 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.

active comparator: 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).

Interventions

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

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 measure

  • 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 ]

Central Contacts and Locations

Central contacts

Luis Buenaver, PHD

4105507986lbuenav1@jhmi.edu

Elizabeth Wysocki, MS

ewysock2@jhu.edu

Locations

Intrepid Spirit Center - Eglin Air Force Base

Recruiting

Eglin Air Force Base, Florida, United States, 32542

Contacts

Mary Fergus

240-204-1573

Naval School Explosive Ordance Disposal - Eglin Air Force Base

Recruiting

Eglin Air Force Base, Florida, United States, 32542

Contacts

Mary Fergus

240-204-1573

Walter Reed National Medical Military Center

Recruiting

Bethesda, Maryland, United States, 20814

Contacts

Seyi Gbade-Alabi

301-550-0350

Womack Army Medical Center

Recruiting

Fort Bragg, North Carolina, United States, 28310

Contacts

Katherine Dermers

301-550-0352

Madigan Army Medical Center

Recruiting

Fort Lewis, Washington, United States, 98431

Contacts

Rachel Satter

301-550-0353

More Information

Sponsor

Johns Hopkins University

Last update posted

Jul 13, 2026

Last verified

Jul, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2026-07-13.