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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 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.

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.

Find a Location

Who is running the clinical trial?

University of VirginiaLead Sponsor
782 Previous Clinical Trials
1,315,558 Total Patients Enrolled
Meghan K Mattos, PhD, RN, CNLPrincipal InvestigatorUniversity of Virginia

Media Library

SHUTi OASIS (Cognitive Behavioral Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05565833 — Phase 2
Mild Cognitive Impairment Research Study Groups: SHUTi OASIS, Patient Education Website
Mild Cognitive Impairment Clinical Trial 2023: SHUTi OASIS Highlights & Side Effects. Trial Name: NCT05565833 — Phase 2
SHUTi OASIS (Cognitive Behavioral Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05565833 — Phase 2
Mild Cognitive Impairment Patient Testimony for trial: Trial Name: NCT05565833 — Phase 2
~89 spots leftby Jan 2028