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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
Stable medication regimen unless medication is known to cause insomnia
The sleep disturbance (or associated daytime fatigue) causes significant distress or impairment in social, occupational, or other areas of functioning over the past three months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 9 weeks, 6 months, 12 months, 18 months, and 24 months
Awards & highlights

Study Summary

This trial will study whether an internet-based cognitive behavioral therapy for insomnia can help improve sleep and cognition in people with mild cognitive impairment.

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.Check my eligibility
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.See study design
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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My medications have not changed recently, except for those causing sleep issues.
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My sleep problems or daytime tiredness significantly affect my daily life.
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I am willing and able to follow the study rules and attend all required visits.
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I have been diagnosed with cognitive impairment.
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I have trouble falling asleep or staying asleep.
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I am 65 years old or older.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Insomnia Severity Index
Secondary outcome measures
Match to Sample Visual Search
Multidimensional Fatigue Symptoms Inventory - Short Form
Paired Associates Learning
+5 more
Other outcome measures
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.

Find a Location

Who is running the clinical trial?

University of VirginiaLead Sponsor
753 Previous Clinical Trials
1,244,896 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are people with the target condition still being accepted into this research program?

"The information available on clinicaltrials.gov reveals that this study is no longer recruiting patients. This trial was initially posted on January 1st 2023 and was last updated September 29th 2022. However, there are 2358 other trials currently looking for participants."

Answered by AI

What is the legal status of SHUTi OASIS?

"SHUTi OASIS received a 2 because, although there is data supporting its safety, efficacy has not yet been proven in clinical trials."

Answered by AI

Who else is applying?

What state do they live in?
Florida
Pennsylvania
California
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
1
3+
0
What site did they apply to?
University of Virginia

What questions have other patients asked about this trial?

How many visits to your facility would be needed? How long would these visits be?
PatientReceived 1 prior treatment

Why did patients apply to this trial?

Want to try new approach. Stop Alzheimers from developing. I'm confused , about the sickness. I'll love someone evaluate my condition and get me help.
PatientReceived 1 prior treatment
I've been on multiple medications over the years without success. I really need to try a new sleep concept that will improve my quality of life.
PatientReceived 1 prior treatment
I've been using sleep medications without success for 25+ years and am very interested in Cognitive Behavior Therapy. My prior sleep studies (2005 & 2010) show that I do not have sleep apnea.
PatientReceived no prior treatments
~96 spots leftby Jan 2028