CBT-I + TMS for Insomnia in Mild Cognitive Impairment

Overseen By Alex Clinical Research Coordinator

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Beth Israel Deaconess Medical Center

Must not be taking: Opiates, Opioids

Disqualifiers: Dementia, Sleep apnea, Parkinson's, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 13

Duration: 11 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if combining brain stimulation with therapy can improve sleep in individuals with mild cognitive issues. It employs a gentle brain stimulation technique called transcranial magnetic stimulation (TMS) alongside cognitive behavioral therapy for insomnia (CBT-I), delivered online. The study includes two groups: one receiving a single daily TMS session and another receiving two sessions per day, both followed by CBT-I. Participants must be at least 60 years old, have mild cognitive problems, and experience insomnia that affects daily life. As an unphased trial, this study provides a unique opportunity to explore innovative treatments for sleep improvement.

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are using opiates or opioids, you cannot participate in the trial.

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

Previous studies have examined transcranial magnetic stimulation (TMS) for safety and effectiveness. Patients generally tolerate it well. Some might experience mild headaches or lightheadedness, but serious side effects are rare. Specifically, research has shown that intermittent theta burst stimulation (iTBS), a type of TMS, is safe for conditions like mild cognitive impairment.

For cognitive behavioral therapy for insomnia (CBT-I), safety data is also positive. Studies show that CBT-I has very few side effects. Some might feel uncomfortable when addressing certain thoughts or behaviors, but these feelings are usually mild and temporary.

Both treatments have been studied in different settings, and evidence suggests they are safe options with manageable side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about combining cognitive behavioral therapy for insomnia (CBT-I) with transcranial magnetic stimulation (TMS) because it offers a novel approach to managing insomnia in individuals with mild cognitive impairment. Unlike traditional sleep medications that often come with side effects and risk of dependency, this treatment uses intermittent theta-burst stimulation (iTBS), a non-invasive method targeting the brain's dorsolateral prefrontal cortex, to potentially enhance sleep quality. Additionally, the integration of a 9-week Internet-delivered CBT-I program could provide long-term behavioral strategies for managing insomnia, making this approach not only innovative but also accessible. This combination might provide faster and more sustained improvements in sleep compared to existing treatments alone.

What evidence suggests that this trial's treatments could be effective for improving sleep quality in mild cognitive impairment?

Research has shown that cognitive behavioral therapy for insomnia (CBT-I) effectively treats insomnia, benefiting 70-80% of patients. In this trial, participants will receive CBT-I combined with transcranial magnetic stimulation (TMS), which researchers are studying for its potential benefits. TMS safely stimulates the brain and has improved sleep quality, especially for those with cognitive difficulties. One study showed that TMS helped people with insomnia sleep better. Additionally, several studies have linked TMS to improved thinking skills, which is beneficial for those with mild cognitive impairment. This trial will explore whether combining CBT-I and TMS can enhance both sleep quality and cognitive function. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for individuals with mild cognitive impairment who also struggle with insomnia. Participants should be interested in non-medication treatments to improve sleep quality.

Inclusion Criteria

I have had trouble falling or staying asleep, causing me significant distress for the past three months.

I am 65 years old or older.

I have been diagnosed with mild cognitive impairment.

Exclusion Criteria

Current diagnosis of major psychiatric disorder (well-controlled depression or anxiety is permitted)

Alcohol or drug abuse within the past year

I have been diagnosed with a neurological condition affecting my sleep.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive transcranial magnetic stimulation (TMS) and cognitive behavioral therapy for insomnia (CBT-I)

11 weeks

10 daily TMS sessions followed by 9 weeks of Internet-delivered CBT-I

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Assessments at Week 3, Week 12, and 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive behavioral therapy for insomnia (CBT-I)
• Transcranial Magnetic Stimulation (TMS) therapy

Trial Overview The study tests a combination of transcranial magnetic stimulation (TMS), a gentle brain stimulation technique, and cognitive behavioral therapy for insomnia (CBT-I), which is a psychological treatment.

How Is the Trial Designed?

Group I: One (1) TMS treatment per day plus CBT-I Active Control 2 Interventions

One (1) daily treatment of intermittent theta-burst stimulation (iTBS) applied to the left dorsolateral prefrontal cortex (L-DLPFC) for 10 days (2 weeks) followed by a 9-week Internet-delivered cognitive behavioral therapy for insomnia (CBT-I) program

Group II: Two (2) TMS treatments per day plus CBT-I Active Control 2 Interventions

Two (2) daily treatments, spaced 1 hour apart, of intermittent theta-burst stimulation (iTBS) applied to the left dorsolateral prefrontal cortex (L-DLPFC) for 10 days (2 weeks) followed by a 9-week Internet-delivered cognitive behavioral therapy for insomnia (CBT-I) program

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?

Beth Israel Deaconess Medical Center

Lead Sponsor

Trials

872

Recruited

12,930,000+

University of Virginia

Collaborator

Trials

802

Recruited

1,342,000+

Published Research Related to This Trial

Cognitive behavioral therapy for insomnia (CBT-I) is a safe and effective treatment for insomnia, even in patients with various co-occurring mental health and medical conditions.

The article reviews the evidence supporting the use of CBT-I in these populations and discusses important considerations for its application, highlighting the need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Behavioral Therapy for Insomnia in Patients with Medical and Psychiatric Comorbidities. Raglan, GB., Swanson, LM., Arnedt, JT.[2019]

Cognitive-behavioral therapy for insomnia (CBT-I) showed positive effects on sleep quality and depressive symptoms in a study of 30 psychiatric outpatients, with 38% achieving normal sleep after treatment.

While CBT-I led to significant improvements within the treatment group over 4 and 8 weeks, there were no significant differences when compared to the control group, suggesting that while beneficial, the effects may not be strong enough to outperform standard care alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of abbreviated CBT for insomnia in psychiatric outpatients: sleep and depression outcomes. Wagley, JN., Rybarczyk, B., Nay, WT., et al.[2022]

Cognitive behavioral therapy for insomnia (CBT-I) is a safe and effective alternative to sleeping medications, but many patients are unaware or reluctant to engage with it, preferring sedative hypnotics instead.

Focus groups with 29 Veterans revealed that patients prefer a stepped-care approach to CBT-I, starting with self-management tools and progressing to provider-delivered therapy if necessary, highlighting the need for multiple outreach efforts and delivery options to increase engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Sign Me Up, I'm Ready!": Helping Patients Prescribed Sleeping Medication Engage with Cognitive Behavioral Therapy for Insomnia (CBT-I). Koffel, E., Branson, M., Amundson, E., et al.[2021]

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]

Cognitive behavioral therapy for insomnia (CBT-I) significantly improves insomnia symptoms, with 36% of patients achieving remission compared to only 16.9% in control groups, indicating its efficacy for those with comorbid conditions.

CBT-I shows medium to large effect sizes for various sleep parameters, such as sleep efficiency and sleep onset latency, and has a small positive effect on comorbid symptoms, particularly benefiting patients with psychiatric conditions more than those with medical conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Behavioral Therapy for Insomnia Comorbid With Psychiatric and Medical Conditions: A Meta-analysis. Wu, JQ., Appleman, ER., Salazar, RD., et al.[2022]

Cognitive behavioral therapy for insomnia (CBT-I) is recognized as the first-line treatment for both uncomplicated insomnia and insomnia associated with other chronic disorders, demonstrating its broad efficacy.

This review aims to summarize efficacy data across various clinical and demographic factors and to outline future research and implementation strategies for CBT-I, highlighting its importance in treating sleep disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

We know CBT-I works, now what? Muench, A., Vargas, I., Grandner, MA., et al.[2022]

Cognitive Behavioral Therapy for Insomnia (CBT-I) is an effective, evidence-based treatment for insomnia that is increasingly recognized as a standalone health issue, especially when it coexists with psychiatric disorders.

Recent studies indicate that CBT-I not only improves sleep quality but also positively impacts psychiatric symptoms in individuals with conditions like anxiety, depression, and PTSD, highlighting its dual benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Behavioural Therapy for Insomnia in Psychiatric Disorders. Jansson-Fröjmark, M., Norell-Clarke, A.[2020]

The Veterans Health Administration developed a digital mental health intervention called Path to Better Sleep (PTBS) to provide accessible cognitive behavioral therapy for insomnia (CBT-I) to veterans, addressing the shortage of trained providers.

Feedback from veteran and spouse evaluation panels significantly influenced the design of PTBS, leading to improvements in user engagement by emphasizing CBT-I efficacy, simplifying content, and incorporating relatable veteran testimonials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Use of Evaluation Panels During the Development of a Digital Intervention for Veterans Based on Cognitive Behavioral Therapy for Insomnia: Qualitative Evaluation Study. Ryan, AT., Brenner, LA., Ulmer, CS., et al.[2023]

Cognitive-behavioral therapy for insomnia (CBT-I) is the preferred treatment for chronic insomnia, but it faces challenges such as a lack of trained therapists and a low response rate among patients.

Alternative methods to CBT-I, including bibliotherapy, phone psychotherapy, brief behavioral therapy, and online CBT-I, are gaining interest, and hypnotics can be used alongside CBT-I to enhance its effectiveness or as a standalone treatment when CBT-I is not accessible.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Cognitive-behavioral therapy and pharmacotherapy for chronic insomnia]. Pchelina, PV., Poluektov, MG.[2019]

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]

Citations

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The effects of transcranial magnetic stimulation on ... In this study, we demonstrated that compared to sham stimulation, rTMS not only improved the sleep quality among undergraduates with insomnia ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04258618

Cognitive Behavioral Therapy for Insomnia with RTMS Transcranial magnetic stimulation (TMS) is an effective treatment for depression, but does not help insomnia symptoms in depressed patients. A form of cognitive ...

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Efficacy and safety of transcranial magnetic stimulation on ... Of the 12 RCTs, 11 studies (92%) reported improved cognitive outcomes, while 1 study (Sedlackova et al.,2008) in vascular MCI participants reported no change.

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Repetitive Transcranial Magnetic Stimulation and Tai Chi ... 1-Hz rTMS targeting the right dorsolateral prefrontal cortex improved the benefits of tai chi chuan for sleep and cognitive performance in older adults.

5. withpower.com withpower.com/trial/phase-mild-cognitive-impairment-mci-2025-118bd

CBT-I + TMS for Insomnia in Mild Cognitive Impairment Cognitive-behavioral therapy for insomnia (CBT-I) is the recommended treatment, showing effectiveness in 70-80% of insomnia patients, but its efficacy ...

6. sleephealthfoundation.org.au sleephealthfoundation.org.au/sleep-disorders/cognitive-behavioural-therapy-for-insomnia-cbt-i

Cognitive Behavioural Therapy for Insomnia (CBT-I) CBT-I has very few side effects, so risks are usually mild. These might include feeling uncomfortable when dealing with unhelpful thoughts and behaviours.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10002474/

Cognitive Behavioral Therapy for Insomnia (CBT-I): A Primer Cognitive Behavioral Therapy for Insomnia (CBT-I) is a multi-component treatment for insomnia that targets difficulties with initiating and/or maintaining sleep ...

8. sleepfoundation.org sleepfoundation.org/insomnia/treatment/cognitive-behavioral-therapy-insomnia

Cognitive Behavioral Therapy for Insomnia (CBT-I) Cognitive behavioral therapy for insomnia (CBT-I) is a short, structured, and evidence-based approach to combating the frustrating symptoms of insomnia.

9. sciencedirect.com sciencedirect.com/science/article/pii/S1087079222000594

Effects of cognitive behavioral therapy for insomnia (CBT-I) ... The effects of cognitive behavioral therapy for insomnia (CBT-I) have consistently been shown to improve insomnia symptoms and other health-related outcomes.

10. academic.oup.com academic.oup.com/sleep/article/47/Supplement_1/A189/7654592

0441 Sleep Disturbance in MCI: A Pilot Study of a Cognitive ... We tested the feasibility of a randomised controlled trial comparing 12-weeks of digital CBT-I vs wait-listed control in older adults with MCI and insomnia.