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CBT-I vs. MBTI for TBI-Related Insomnia

N/A
Recruiting
Led By Luis Buenaver, PhD
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Display sufficient cognitive capacity to provide informed consent (Montreal Cognitive Assessment (MoCA), Z-score > -2149)
18 years of age or greater
Must not have
History of neurological diseases other than TBI and not attributable to TBI
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at the end of treatment, and 2-, 6- and 12-weeks post treatment
Awards & highlights

Summary

"This trial will compare two types of therapy (Cognitive Behavioral Therapy for Insomnia and Mindfulness-Based Treatment for Insomnia) delivered through telemedicine to treat insomnia and depressive symptoms in individuals with mild to

Who is the study for?
This trial is for adults over 18 with mild to moderate traumatic brain injury (TBI) who have insomnia and post-traumatic stress symptoms. They must have had the TBI for at least 3 weeks, show signs of insomnia, be able to give informed consent, and use a computer.
What is being tested?
The study compares two treatments delivered via telemedicine: Cognitive Behavioral Therapy for Insomnia (CBT-I) and Mindfulness-Based Treatment for Insomnia (MBTI). Each participant receives six sessions to see which method better improves sleep and reduces depressive symptoms after TBI.
What are the potential side effects?
While not explicitly stated, side effects may include discomfort from discussing personal issues during therapy sessions or potential frustration if techniques do not immediately improve sleep or mood.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am mentally capable of understanding and consenting to participate.
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I am 18 years old or older.
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I meet the criteria for a traumatic brain injury as defined by the VAMC and DoD.
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I have severe insomnia.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a neurological condition not caused by or related to a traumatic brain injury.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at the end of treatment, and 2-, 6- and 12-weeks post treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and at the end of treatment, and 2-, 6- and 12-weeks post treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Insomnia severity as assessed by the insomnia severity index (ISI)
Secondary study objectives
Change in Depressive Symptoms as assessed by the Patient Health Questionnaire-8 Item (PHQ-8)
Change in Pre-sleep Arousal as assessed by the Pre-sleep Arousal Scale (PSAS)
Other study objectives
Change in Neurocognitive functioning as assessed by the Automated Neuropsychological Assessment Metrics (ANAM)

Trial Design

2Treatment groups
Active Control
Group I: Mindfulness-based treatment for insomnia (MBTI)Active Control1 Intervention
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 II: Cognitive behavioral therapy for insomnia (CBT-I)Active Control1 Intervention
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.

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Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,307 Previous Clinical Trials
14,861,549 Total Patients Enrolled
Department of Defense Congressionally Directed Medical Research ProgramUNKNOWN
2 Previous Clinical Trials
280 Total Patients Enrolled
Luis Buenaver, PhDPrincipal InvestigatorJohns Hopkins School of Medicine
~240 spots leftby May 2026
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