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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 belowSelect...
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:Select...
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
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 moreOther study objectives
Blood coagulation tests
Falls frequency
Sleeplessness
+3 moreTrial 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.
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am still recovering from a brain condition.My sleep problems or daytime tiredness significantly affect my daily life.I haven't used stimulating medications after 5pm or for less than 3 months.I am willing and able to follow the study rules and attend all required visits.I have been diagnosed with cognitive impairment.My medications have not changed recently, except for those for insomnia.You have been found to have trouble thinking clearly during the study assessment.Your sleep schedule is not consistent or regular.You have a significant risk of harming yourself.You have had problems with drinking too much alcohol or using drugs in the past year.The study will check for severe depression during the screening process.I have trouble falling asleep or staying asleep.I started seeing a mental health professional in the last 3 months.I do not have untreated sleep disorders like sleep apnea.I am currently receiving chemotherapy.I am currently being treated for an overactive thyroid.I have asthma or breathing issues that worsen at night.I am 65 years old or older.I have been diagnosed with Huntington's or Parkinson's disease.I am receiving therapy for insomnia.I am taking opioids for chronic pain.My epilepsy treatment hasn't been stable for 3 months.I have trouble falling asleep or staying asleep.My sleep problems or tiredness during the day have significantly affected my daily life for the past three months.
Research Study Groups:
This trial has the following groups:- Group 1: SHUTi OASIS
- Group 2: Patient Education Website
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Mild Cognitive Impairment Patient Testimony for trial: Trial Name: NCT05565833 — Phase 2
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