360 Participants Needed

CBT-I vs. MBTI for TBI-Related Insomnia

Recruiting at 4 trial locations
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TT
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Overseen ByElizabeth Wysocki, MS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Johns Hopkins University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

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.

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.12345

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.16789

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.124610

Who Is on the Research Team?

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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.
My medical records show I had a mild to moderate traumatic brain injury.
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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.
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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?
2Treatment groups
Active Control
Group I: Mindfulness-based treatment for insomnia (MBTI)Active Control1 Intervention
Group II: Cognitive behavioral therapy for insomnia (CBT-I)Active Control1 Intervention

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

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Approved in United States as Cognitive Behavioral Therapy for Insomnia for:
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Approved in European Union as Cognitive Behavioural Therapy for Insomnia for:
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Approved in Canada as Cognitive Behavioral Therapy for Insomnia for:

Find a Clinic Near You

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.
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.
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., Dรญaz-Silveira, C., Burgos-Juliรกn, 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.
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]

Citations

Does cognitive-behavioural therapy improve sleep outcomes in individuals with traumatic brain injury: a scoping review. [2021]
Can mindfulness-based interventions improve outcomes in cognitive-behavioural therapy for chronic insomnia disorder in the general population? Systematic review and meta-analysis. [2023]
Comparing the Effects of Mindfulness-Based Cognitive Therapy and Sleep Psycho-Education with Exercise on Chronic Insomnia: A Randomised Controlled Trial. [2022]
Mindfulness-based therapy for insomnia for older adults with sleep difficulties: a randomized clinical trial. [2023]
Mindfulness as an Adjunct or Alternative to CBT-I. [2023]
Insomnia and its effective non-pharmacologic treatment. [2018]
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]
Can Cognitive Behavioral Therapy for Insomnia also treat fatigue, pain, and mood symptoms in individuals with traumatic brain injury? - A multiple case report. [2018]
Perspective: Cognitive Behavioral Therapy for Insomnia Is a Promising Intervention for Mild Traumatic Brain Injury. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Brief Behavioral Treatment of Insomnia. [2019]
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