What is the mechanism of action of this treatment?

Common treatments for Mild Cognitive Impairment (MCI) often focus on improving cognitive function and overall brain health. Internet-delivered Cognitive Behavioral Therapy for Insomnia (CBT-I) is one such treatment that uses cognitive and behavioral techniques to enhance sleep patterns. This is significant for MCI patients because poor sleep can worsen cognitive decline. By improving sleep quality, CBT-I can reduce daytime sleepiness and enhance cognitive functions such as memory, attention, and executive function, potentially slowing the progression of MCI.

What side effects are associated with this type of intervention?

Cognitive Behavioral Therapy for Insomnia (CBT-I), including its internet-delivered format, is generally well-tolerated with minimal side effects. Common side effects may include temporary increases in anxiety or frustration, especially when implementing sleep restriction or stimulus control techniques. These side effects are usually mild and diminish as the individual adapts to the new sleep patterns. Unlike pharmacologic treatments, CBT-I does not carry risks of daytime sleepiness, dependency, or cognitive impairment, making it a safer long-term option for improving sleep and potentially enhancing cognitive health.

What prior FDA approvals exist?

There are no specific FDA-approved drugs for the treatment of Mild Cognitive Impairment (MCI) mentioned in the provided context. However, cognitive and behavioral interventions, such as Internet-delivered Cognitive Behavioral Therapy for Insomnia (CBT-I), are being studied for their potential to improve sleep patterns and enhance cognitive health in individuals with MCI. These nonpharmacologic approaches focus on modifying sleep behaviors and cognitive processes to address insomnia and its associated cognitive difficulties.

What other types of research exist?

Promising novel alternatives to Internet-delivered CBT-I for Mild Cognitive Impairment patients include: 1) Pharmacologic treatments such as melatonin, which has shown effectiveness in reducing sleep onset latency and improving sleep quality in children with neurodevelopmental disorders and may have similar benefits for MCI patients. 2) Hypnosis, which has demonstrated efficacy in reducing hot flashes and improving sleep in menopausal women, suggesting potential benefits for sleep disturbances in MCI. 3) Mind-body-based therapies, including mindfulness and relaxation techniques, which have shown positive outcomes in small studies and could be adapted for MCI patients. 4) Technology-enhanced behavioral interventions, such as smartphone applications and interactive voice response systems based on CBT principles, which have shown mixed but promising results in other populations and could be tailored for MCI patients.

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Cognitive Behavioral Therapy

Internet-Based Cognitive Behavioral Therapy for Insomnia and Mild Cognitive Impairment

Phase 2

Recruiting

Led By Meghan K Mattos, PhD, RN, CNL

Research Sponsored by University of Virginia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Cognitive impairment through study assessment

Male or female, aged ≥ 65 years of age

Must not have

Other untreated sleep disorders (e.g., obstructive sleep apnea)

Currently undergoing chemotherapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 9 weeks, 6 months, 12 months, 18 months, and 24 months

Summary

This trial tests an online therapy to help people with insomnia and mild cognitive issues. The therapy aims to improve sleep by changing negative thoughts and behaviors related to sleep. Researchers will see if better sleep also helps with cognitive health. Cognitive Behavioral Therapy for Insomnia (CBT-I) has been shown to be effective in improving sleep quality and reducing insomnia symptoms through various delivery methods, including online platforms.

Who is the study for?

This trial is for US residents aged 65 or older with mild cognitive impairment and insomnia, who can read English and have internet access. They must be willing to follow the study procedures for its duration. Excluded are those with irregular sleep schedules, substance abuse issues, severe depression risk, recent psychological treatments, certain medical conditions like untreated sleep disorders or epilepsy without stable treatment.

What is being tested?

The SHUTi MIND trial tests an online cognitive behavioral therapy program (SHUTi OASIS) against patient education to see if it improves sleep and cognition in people with mild cognitive impairment and insomnia. Participants will be randomly assigned to one of these two approaches.

What are the potential side effects?

Since this trial involves non-medical interventions like online therapy and education programs, side effects may include discomfort from using technology or emotional distress but no physical side effects are expected.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with cognitive impairment.

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I am 65 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have untreated sleep disorders like sleep apnea.

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I am currently receiving chemotherapy.

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I am currently being treated for an overactive thyroid.

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I have asthma or breathing issues that worsen at night.

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I have been diagnosed with Huntington's or Parkinson's disease.

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I am receiving therapy for insomnia.

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I am taking opioids for chronic pain.

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My epilepsy treatment hasn't been stable for 3 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 9 weeks, 6 months, 12 months, 18 months, and 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 9 weeks, 6 months, 12 months, 18 months, and 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 9 weeks, 6 months, 12 months, 18 months, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Insomnia Severity Index

Secondary study objectives

Match to Sample Visual Search

Multidimensional Fatigue Symptoms Inventory - Short Form

Paired Associates Learning

+5 more

Other study objectives

Blood coagulation tests

Falls frequency

Sleeplessness

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: SHUTi OASISExperimental Treatment1 Intervention

Participants will be assigned to the SHUTi (Sleep Healthy Using the Internet) for Older Adult Sufferers of Insomnia and Sleeplessness (OASIS) online intervention optimized for older adults. CBTi will be delivered online and metered out over time with each new core becoming available one week after the completion of the previous core. The intervention period is 9 weeks. They will spend 1-2 hours during the intervention period completing daily sleep diaries as well as interactive core content covering topics of sleep behaviors, sleep thoughts, sleep education, and relapse prevention targeting issues specific to older adults. As users progress through the intervention, they will receive automated, tailored instructions on how to improve their sleep.

Group II: Patient Education WebsitePlacebo Group1 Intervention

Participants will be assigned to a relevant patient education website. It will include information about insomnia symptoms, diagnosis, prognosis, and information about CBT strategies for the older adult. Unlike SHUTi, the content will not be tailored and will be presented all at once.

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Mild Cognitive Impairment (MCI) often focus on improving cognitive function and overall brain health. Internet-delivered Cognitive Behavioral Therapy for Insomnia (CBT-I) is one such treatment that uses cognitive and behavioral techniques to enhance sleep patterns. This is significant for MCI patients because poor sleep can worsen cognitive decline. By improving sleep quality, CBT-I can reduce daytime sleepiness and enhance cognitive functions such as memory, attention, and executive function, potentially slowing the progression of MCI.

Treatment of insomnia in older adults.