144 Participants Needed

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

MK
Overseen ByMeghan K Mattos, PhD, RN, CNL
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 1 JurisdictionThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial requires that participants have a stable medication regimen unless the medication is known to cause insomnia. If your current medication is stable and not causing insomnia, you likely won't need to stop taking it.

Is Internet-Based Cognitive Behavioral Therapy for Insomnia safe for humans?

The studies on Internet-Based Cognitive Behavioral Therapy for Insomnia, such as SHUTi, suggest that it is generally safe for humans. Participants in these studies reported positive experiences and improvements in sleep without any significant safety concerns.12345

How is the SHUTi OASIS treatment different from other treatments for insomnia and mild cognitive impairment?

SHUTi OASIS is unique because it is an internet-based cognitive behavioral therapy specifically designed for older adults with insomnia and mild cognitive impairment, offering a convenient and accessible option compared to traditional in-person therapy sessions.36789

What data supports the effectiveness of the treatment Internet-Based Cognitive Behavioral Therapy for Insomnia and Mild Cognitive Impairment?

Research shows that Internet-based cognitive-behavioral therapy for insomnia (CBT-I), like SHUTi, is effective in improving sleep quality and reducing insomnia symptoms. Studies have found it to be convenient, understandable, and useful, with most users experiencing improved sleep and quality of life.1351011

Who Is on the Research Team?

MK

Meghan K Mattos, PhD, RN, CNL

Principal Investigator

University of Virginia

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Provision of signed and dated informed consent form
My sleep problems or daytime tiredness significantly affect my daily life.
I am willing and able to follow the study rules and attend all required visits.
See 9 more

Exclusion Criteria

Psychotic or bipolar disorder
I am still recovering from a brain condition.
I haven't used stimulating medications after 5pm or for less than 3 months.
See 13 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-assessment

Participants complete an online cognitive test, an online questionnaire, and two weeks of sleep diaries

2 weeks

Treatment

Participants receive either the Internet-based CBT-I intervention or patient education for 9 weeks

9 weeks

Post-assessment

Participants complete the post-assessment battery including cognitive test, questionnaires, and diaries

1 week

Follow-up

Participants are monitored for changes in sleep, cognitive status, and other health measures at 6, 12, 18, and 24 months

24 months

What Are the Treatments Tested in This Trial?

Interventions

  • Patient Education
  • SHUTi OASIS
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: SHUTi OASISExperimental Treatment1 Intervention
Group II: Patient Education WebsitePlacebo Group1 Intervention

SHUTi OASIS is already approved in United States for the following indications:

🇺🇸
Approved in United States as SHUTi OASIS for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Virginia

Lead Sponsor

Trials
802
Recruited
1,342,000+

Published Research Related to This Trial

Self-help cognitive-behavioral therapy for insomnia (CBT-I) was found to be effective in improving sleep efficiency and reducing insomnia symptoms in a study of 312 participants over 6 weeks, with benefits maintained at 12 weeks post-treatment.
Adding brief telephone support to the self-help CBT-I program further enhanced its effectiveness, particularly in improving sleep onset latency and overall sleep quality.
Weekly brief phone support in self-help cognitive behavioral therapy for insomnia disorder: Relevance to adherence and efficacy.Ho, FY., Chung, KF., Yeung, WF., et al.[2018]
A systematic review of 11 studies focused on elderly patients (aged 60 and above) with insomnia found that information and communication technologies (ICT) can significantly enhance insomnia treatment, particularly through Internet-delivered cognitive behavioral therapy (CBTi), virtual coaches, and sleep technologies.
Implementing these technological solutions not only has the potential to improve the quality of life for elderly patients suffering from insomnia but also to reduce healthcare costs and the need for institutional care.
Insomnia and Information and Communication Technologies (ICT) in Elderly People: A Systematic Review.Salvemini, A., D'Onofrio, G., Ciccone, F., et al.[2020]
The unguided Internet-based cognitive-behavioral treatment program for insomnia (SHUTi) significantly improved sleep outcomes in 181 participants over a nine-week period, outperforming a web-based patient education group.
Improvements in insomnia severity were maintained at a six-month follow-up for those who completed the SHUTi program, suggesting its potential as a first-line treatment option, although high dropout rates may affect the overall applicability of the results.
The Short-Term Efficacy of an Unguided Internet-Based Cognitive-Behavioral Therapy for Insomnia: A Randomized Controlled Trial With a Six-Month Nonrandomized Follow-Up.Hagatun, S., Vedaa, Ø., Nordgreen, T., et al.[2022]

Citations

Weekly brief phone support in self-help cognitive behavioral therapy for insomnia disorder: Relevance to adherence and efficacy. [2018]
Insomnia and Information and Communication Technologies (ICT) in Elderly People: A Systematic Review. [2020]
The Short-Term Efficacy of an Unguided Internet-Based Cognitive-Behavioral Therapy for Insomnia: A Randomized Controlled Trial With a Six-Month Nonrandomized Follow-Up. [2022]
Internet-Based Cognitive-Behavioral Therapy for Insomnia in Adults With Asthma: A Pilot Study. [2021]
Development and Perceived Utility and Impact of an Internet Intervention for Insomnia. [2022]
Real-World Evaluation of Clinical Response and Long-Term Healthcare Resource Utilization Patterns Following Treatment with a Digital Therapeutic for Chronic Insomnia. [2022]
Cognitive mechanisms of sleep outcomes in a randomized clinical trial of internet-based cognitive behavioral therapy for insomnia. [2019]
Developing and Testing a Web-Based Provider Training for Cognitive Behavioral Therapy of Insomnia. [2021]
Nonpharmacologic management of chronic insomnia. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
A randomized controlled trial to test a behavioral sleep intervention to improve insomnia symptoms in older adults with mild cognitive impairment: Multicomponent Behavioral Sleep Intervention (MBSI) protocol. [2023]
Effectiveness of internet-based CBT-I for the treatment of chronic subthreshold to moderate insomnia. [2023]
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