CBT-I vs. MBTI for TBI-Related Insomnia

Recruiting at 4 trial locations

Overseen By Elizabeth Wysocki, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Neurological diseases, Sleep apnea, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 9

Duration: 6 weeks

360 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two therapies to treat insomnia and reduce depressive symptoms in individuals with mild to moderate traumatic brain injury (TBI) and post-traumatic stress symptoms (PTSS). One group will undergo cognitive behavioral therapy for insomnia (CBT-I), which focuses on changing sleep habits and thoughts about sleep. The other group will try mindfulness-based treatment for insomnia (MBTI), combining mindfulness exercises with sleep behavior strategies. The trial aims to determine which therapy more effectively improves sleep. Ideal participants are current or former military members who have experienced TBI and insomnia for over 90 days and have computer access. As an unphased trial, this study provides a unique opportunity to explore innovative therapies for enhancing sleep and mental health.

Will I have to stop taking my current medications?

The trial does not require you to stop taking your current medications, but if you are using psychotropic medications, you need to be on a stable dosage for at least three weeks before the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both cognitive behavioral therapy for insomnia (CBT-I) and mindfulness-based treatment for insomnia (MBTI) are generally safe. Studies indicate that CBT-I helps 70 to 80% of people with insomnia achieve long-lasting improvements. Often recommended over sleeping pills, CBT-I is well-tolerated with few side effects.

For MBTI, research has found it can improve sleep and reduce the mental stress that worsens insomnia. Although detailed safety data for MBTI is limited, its focus on mindfulness practices, such as meditation and relaxation, is usually considered safe.

Overall, both treatments do not involve medication, reducing the risk of serious side effects. Participants typically find these treatments easy to handle. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for TBI-related insomnia because they offer innovative approaches to managing sleep issues. Unlike traditional treatments that might rely on medication, both Cognitive Behavioral Therapy for Insomnia (CBT-I) and Mindfulness-Based Treatment for Insomnia (MBTI) focus on non-drug strategies. CBT-I uniquely combines cognitive and behavioral techniques, such as cognitive restructuring and sleep restriction, to change sleep habits and thoughts about sleep. MBTI integrates mindfulness with sleep restriction and stimulus control, promoting awareness and reducing hyperarousal. These approaches aim to address insomnia's root causes, offering potentially effective and long-lasting solutions without relying on medications.

What evidence suggests that this trial's treatments could be effective for TBI-related insomnia?

Research has shown that cognitive behavioral therapy for insomnia (CBT-I), one of the treatments in this trial, works well, with 70 to 80% of patients experiencing long-lasting benefits. One study found that CBT-I helped people fall asleep faster and wake up less during the night. Mindfulness-based treatment for insomnia (MBTI), another treatment option in this trial, also appears promising. It improves sleep by increasing awareness of sleep-friendly habits and reducing stress. A study on a similar mindfulness program showed that participants' insomnia symptoms improved. Both treatments have strong evidence supporting their effectiveness in enhancing sleep quality. ^{1 5 6 7 8}

Who Is on the Research Team?

Luis Buenaver, PhD

Principal Investigator

Johns Hopkins School of Medicine

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am mentally capable of understanding and consenting to participate.

I meet the criteria for a traumatic brain injury as defined by the VAMC and DoD.

Access to and ability to use a computer

Exclusion Criteria

Patients 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

Known history of intellectual or developmental disability

I have moderate to severe sleep apnea.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either CBT-I or MBTI treatment over 6 sessions delivered via telemedicine

6 weeks

6 sessions (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 2-, 6-, and 12-weeks post-treatment

12 weeks

3 assessments (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive behavioral therapy for insomnia (CBT-I)
• Mindfulness-based treatment for insomnia (MBTI)

Trial Overview

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.

How Is the Trial Designed?

Group I: Mindfulness-based treatment for insomnia (MBTI) Active Control 1 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 Control 1 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.

Cognitive behavioral therapy for insomnia (CBT-I) is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Cognitive Behavioral Therapy for Insomnia for:

• Insomnia disorder
• Major depressive disorder with comorbid insomnia
• Traumatic brain injury-related insomnia
• Post-traumatic stress symptoms

Approved in European Union as Cognitive Behavioural Therapy for Insomnia for:

• Insomnia disorder
• Major depressive disorder with comorbid insomnia

Approved in Canada as Cognitive Behavioral Therapy for Insomnia for:

• Insomnia disorder
• Major depressive disorder with comorbid insomnia

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Department of Defense Congressionally Directed Medical Research Program

Collaborator

Trials

3

Recruited

640+

Published Research Related to This Trial

Cognitive-behavioral therapy for insomnia (CBT-I) shows promise in improving sleep efficiency and quality in individuals with traumatic brain injury (TBI), based on a review of five studies.

Despite positive outcomes, the review highlights a significant limitation due to the small number of participants and studies, indicating a need for more comprehensive research to confirm the efficacy of CBT-I in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does cognitive-behavioural therapy improve sleep outcomes in individuals with traumatic brain injury: a scoping review. Ludwig, R., Vaduvathiriyan, P., Siengsukon, C.[2021]

Mindfulness-based interventions (MBIs) showed a small to medium effect on insomnia severity, but the results were not statistically significant when compared to active control groups, indicating limited efficacy as a standalone treatment for chronic insomnia disorder.

The analysis of nine studies, including randomized controlled trials and non-randomized studies, could not conclusively demonstrate that MBIs enhance the effectiveness of cognitive-behavioral therapy for insomnia (CBT-I), suggesting a need for better-designed studies to explore this potential combination.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can mindfulness-based interventions improve outcomes in cognitive-behavioural therapy for chronic insomnia disorder in the general population? Systematic review and meta-analysis. de Entrambasaguas, M., Díaz-Silveira, C., Burgos-Julián, FA., et al.[2023]

Cognitive Behavioral Therapy for Insomnia (CBT-I) did not lead to clinically significant improvements in insomnia severity for three participants with traumatic brain injury (TBI), but trends toward improvement were noted.

All participants experienced significant reductions in anxiety, with effects lasting for two of them at follow-up, indicating that CBT-I may help alleviate mood disturbances associated with TBI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can Cognitive Behavioral Therapy for Insomnia also treat fatigue, pain, and mood symptoms in individuals with traumatic brain injury? - A multiple case report. Lu, W., Krellman, JW., Dijkers, MP.[2018]

Mindfulness-based cognitive therapy for insomnia (MBCT-I) showed a significant short-term reduction in insomnia severity compared to a sleep psycho-education with exercise control (PEEC) group, with a notable effect size at 2 months.

While MBCT-I improved wake time after sleep onset at 2 and 5 months, both MBCT-I and PEEC groups exhibited similar long-term improvements in sleep parameters by 8 months, indicating that MBCT-I may not provide sustained benefits over PEEC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing the Effects of Mindfulness-Based Cognitive Therapy and Sleep Psycho-Education with Exercise on Chronic Insomnia: A Randomised Controlled Trial. Wong, SY., Zhang, DX., Li, CC., et al.[2022]

Mindfulness-based interventions (MBIs) have been shown to effectively improve sleep and reduce cognitive arousal, which are key factors in managing insomnia.

The article suggests that MBIs can be used as an adjunct or alternative treatment to cognitive behavioral therapy for insomnia (CBT-I), highlighting their potential role in enhancing sleep treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness as an Adjunct or Alternative to CBT-I. Ong, JC., Kalmbach, DA.[2023]

Cognitive behavioral therapy for insomnia (CBTi) is a highly effective non-drug treatment for insomnia, showing comparable efficacy to sleep medications in randomized control trials, with better long-term maintenance of benefits after treatment ends.

Due to its strong empirical support, both the National Institutes of Health and the American Academy of Sleep Medicine recommend CBTi as the standard treatment for insomnia, highlighting its importance in addressing the public health burden of this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Insomnia and its effective non-pharmacologic treatment. Siebern, AT., Manber, R.[2018]

Mindfulness-Based Therapy for Insomnia (MBTI) improved self-reported sleep quality and significantly increased N2 sleep, while the sleep hygiene education and exercise program (SHEEP) led to improvements in N3 sleep, indicating that both interventions have unique benefits for sleep architecture.

The study, involving 94 participants and using ambulatory polysomnography to measure sleep changes, suggests that mindfulness training may work through different mechanisms compared to traditional sleep interventions, as evidenced by the distinct effects on sleep macroarchitecture.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dissociable changes in sleep architecture with mindfulness and sleep hygiene intervention in older adults: Secondary and exploratory analysis of polysomnography data from the Mindfulness Sleep Therapy (MIST) trial. Wong, KF., Perini, F., Lin, J., et al.[2022]

Insomnia affects 30-50% of patients with mild traumatic brain injury (mTBI) and is unlikely to resolve without specific treatment, making it a crucial target for improving recovery.

Cognitive-behavioral therapy for insomnia (CBT-I) is the recommended treatment, showing effectiveness in 70-80% of insomnia patients, but its efficacy specifically for insomnia related to mTBI needs further clinical testing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perspective: Cognitive Behavioral Therapy for Insomnia Is a Promising Intervention for Mild Traumatic Brain Injury. Dietch, JR., Furst, AJ.[2022]

Brief behavioral treatment for insomnia (BBTI) is a 4-session program that can effectively reduce insomnia symptoms, such as difficulty falling asleep and waking up during the night, making it a practical option for non-psychologist health professionals to administer.

BBTI has shown promising results, including cases of full remission from insomnia, and ongoing clinical trials are exploring its efficacy in different treatment settings and delivery methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief Behavioral Treatment of Insomnia. Gunn, HE., Tutek, J., Buysse, DJ.[2019]

Mindfulness-Based Therapy for Insomnia (MBTI) significantly reduced insomnia severity more than the Sleep Hygiene, Education, and Exercise Program (SHEEP) in a study of 127 older adults, indicating its effectiveness as a treatment option.

MBTI also improved objective sleep measures, such as wake after sleep onset and sleep onset latency, while no participants experienced adverse effects, suggesting it is a safe alternative for those struggling with insomnia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based therapy for insomnia for older adults with sleep difficulties: a randomized clinical trial. Perini, F., Wong, KF., Lin, J., et al.[2023]

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