CBT-I + TMS for Insomnia in Mild Cognitive Impairment

Overseen By Peter J Fried, PhD

Age: 65+

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

Trial Summary

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.

What data supports the effectiveness of this treatment for insomnia in mild cognitive impairment?

Cognitive Behavioral Therapy for Insomnia (CBT-I) is a well-established treatment for insomnia, showing effectiveness in 70-80% of patients, with about 50% experiencing complete relief from symptoms. It is considered the first-line treatment for insomnia, even when it occurs alongside other chronic conditions. ^{1 2 3 4 5}

Is CBT-I safe for humans?

Cognitive Behavioral Therapy for Insomnia (CBT-I) is considered a safe treatment for insomnia, even when it occurs alongside other medical or psychiatric conditions. ^{2 6 7 8 9}

How is the treatment CBT-I + TMS for insomnia in mild cognitive impairment different from other treatments?

CBT-I (Cognitive Behavioral Therapy for Insomnia) is unique because it is a non-drug treatment that focuses on changing sleep habits and behaviors, and it is often combined with other methods like TMS (Transcranial Magnetic Stimulation) to enhance its effects. Unlike medications, CBT-I addresses the root causes of insomnia and can provide long-lasting benefits without the side effects associated with drugs. ^{1 5 6 9 10}

What is the purpose of this trial?

The goal of this study is to test a new way to improve sleep quality in persons living with mild cognitive impairment. The treatment combines a safe and gentle way to stimulate the brain, called transcranial magnetic stimulation, with a psychological treatment, called cognitive behavioral therapy for insomnia.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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) 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]

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) 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 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) 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) 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]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

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

2. England pubmed.ncbi.nlm.nih.gov

We know CBT-I works, now what? [2022]

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

Effectiveness of abbreviated CBT for insomnia in psychiatric outpatients: sleep and depression outcomes. [2022]

4. Canada 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. [2023]

5. England pubmed.ncbi.nlm.nih.gov

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

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

Cognitive Behavioral Therapy for Insomnia Comorbid With Psychiatric and Medical Conditions: A Meta-analysis. [2022]

7. England 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). [2021]

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

Cognitive Behavioral Therapy for Insomnia in Patients with Medical and Psychiatric Comorbidities. [2019]

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

Cognitive Behavioural Therapy for Insomnia in Psychiatric Disorders. [2020]

10. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Cognitive-behavioral therapy and pharmacotherapy for chronic insomnia]. [2019]