CBT-I vs. MBTI for TBI-Related Insomnia

Recruiting at 4 trial locations

Overseen by Luis Buenaver, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Johns Hopkins University

Disqualifiers: Neurological diseases, Sleep apnea, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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).

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.

What data supports the effectiveness of the treatment Cognitive Behavioral Therapy for Insomnia (CBT-I) and Mindfulness-Based Treatment for Insomnia (MBTI) for TBI-related insomnia?

Research shows that Cognitive Behavioral Therapy for Insomnia (CBT-I) is commonly used to improve sleep outcomes in individuals with traumatic brain injury (TBI). Mindfulness-Based Treatments for Insomnia (MBTI) have been found to improve sleep and reduce cognitive arousal, which are important for managing insomnia. ^{1 2 3 4 5}

Is CBT-I and MBTI safe for treating insomnia?

Cognitive Behavioral Therapy for Insomnia (CBT-I) is considered a safe and effective non-drug treatment for insomnia, with strong support from health organizations. Mindfulness-Based Therapy for Insomnia (MBTI) is also being explored as a safe alternative, especially for older adults, though more research is needed to fully understand its safety profile. ^{2 3 4 6 7}

How does the treatment CBT-I vs. MBTI for TBI-related insomnia differ from other treatments?

CBT-I (Cognitive Behavioral Therapy for Insomnia) and MBTI (Mindfulness-Based Treatment for Insomnia) are unique because they focus on changing sleep-related thoughts and behaviors and incorporating mindfulness to reduce stress, rather than using medication. These therapies are particularly promising for individuals with traumatic brain injury (TBI) as they not only address insomnia but may also help with related issues like mood, pain, and cognitive function. ^{1 2 8 9 10}

Research Team

Luis Buenaver, PhD

Principal Investigator

Johns Hopkins School of Medicine

Eligibility Criteria

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 am 18 years old or older.

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

Exclusion Criteria

Communication difficulties or inability to speak English

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

Trial Timeline

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)

Treatment Details

Interventions

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

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.

Participant Groups

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 Canada for the following indications:

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+

Findings from Research

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]

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 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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Does cognitive-behavioural therapy improve sleep outcomes in individuals with traumatic brain injury: a scoping review. [2021]

2. England 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. [2023]

3. Switzerland 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. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Mindfulness-based therapy for insomnia for older adults with sleep difficulties: a randomized clinical trial. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Mindfulness as an Adjunct or Alternative to CBT-I. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Insomnia and its effective non-pharmacologic treatment. [2018]

7. United States 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. [2022]

8. Netherlands 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. [2018]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Perspective: Cognitive Behavioral Therapy for Insomnia Is a Promising Intervention for Mild Traumatic Brain Injury. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Brief Behavioral Treatment of Insomnia. [2019]