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

Overseen By Meghan K Mattos, PhD, RN, CNL

Age: 65+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Virginia

Must not be taking: Opioids, Stimulants

Disqualifiers: Psychiatric treatment, Parkinson's, Chemotherapy, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 9 weeks

144 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if an online program called SHUTi OASIS can assist people with insomnia and mild cognitive impairment. Participants will either use the SHUTi OASIS program or access a patient education website. The study will compare the effects of these two approaches on sleep and cognitive health. It seeks individuals aged 65 or older who struggle with falling or staying asleep and find that their sleep issues interfere with daily activities. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

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.

What prior data suggests that this Internet-based cognitive behavioral therapy is safe for individuals with insomnia and mild cognitive impairment?

Research has shown that the SHUTi OASIS program is generally safe for older adults with sleep difficulties. In previous studies, participants using SHUTi OASIS slept better and felt more refreshed in the morning, without experiencing major negative effects. No serious side effects were observed. This suggests that the digital therapy is safe and well-tolerated for individuals with mild memory problems and insomnia. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the SHUTi OASIS treatment for insomnia and mild cognitive impairment because it offers a unique, internet-based approach tailored specifically for older adults. Unlike traditional in-person cognitive behavioral therapy for insomnia (CBTi), SHUTi OASIS delivers therapy online, allowing participants to access and engage with personalized content at their own pace over a 9-week period. This tailored, digital format not only makes the therapy more accessible but also provides automated, individualized instructions to help users improve their sleep habits, which could lead to better long-term outcomes for managing insomnia and associated cognitive issues.

What evidence suggests that this trial's treatments could be effective for insomnia and mild cognitive impairment?

Research shows that SHUTi OASIS, an online program for improving sleep, works well for older adults with insomnia. Studies have found that people using SHUTi OASIS sleep better. Early results also suggest that older adults with memory problems can use SHUTi OASIS and improve their sleep. Participants in this trial may receive SHUTi OASIS, which provides personalized online guidance to help users change their sleep habits and thoughts. SHUTi OASIS is especially useful for older adults dealing with both insomnia and mild memory issues. ^{1 2 3 5 6}

Who Is on the Research Team?

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.

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.

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?

Group I: SHUTi OASIS Experimental Treatment 1 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 Website Placebo Group 1 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.

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

Approved in United States as SHUTi OASIS for:

• Insomnia
• Mild Cognitive Impairment

Who Is Running the Clinical Trial?

University of Virginia

Lead Sponsor

Trials

802

Recruited

1,342,000+

Published Research Related to This Trial

A web-based training course for Cognitive Behavioral Therapy for Insomnia (CBT-I), called CBTIweb.org, was developed and evaluated, showing high usability and significant knowledge gains among participants, with a knowledge increase from 69% to 92% correct after training.

The effectiveness of CBTIweb.org was found to be equivalent to traditional in-person workshops, suggesting it can effectively train behavioral health providers in CBT-I, thus addressing the shortage of trained professionals and allowing for broader access to insomnia treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing and Testing a Web-Based Provider Training for Cognitive Behavioral Therapy of Insomnia. Taylor, DJ., Dietch, JR., Pruiksma, K., et al.[2021]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

In a study of 303 participants, an online cognitive behavioral therapy intervention for insomnia (SHUTi) significantly improved insomnia knowledge and reduced dysfunctional beliefs about sleep, which were linked to better long-term sleep outcomes after 12 months.

The changes in cognitive variables, such as insomnia knowledge and beliefs about sleep, were found to mediate the effectiveness of the SHUTi intervention, suggesting that addressing these cognitive factors is crucial for achieving lasting improvements in sleep quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive mechanisms of sleep outcomes in a randomized clinical trial of internet-based cognitive behavioral therapy for insomnia. Chow, PI., Ingersoll, KS., Thorndike, FP., et al.[2019]

In a study of 248 patients with chronic insomnia, treatment with Somryst®, a digital cognitive behavioral therapy for insomnia (CBT-I), led to a significant 37.2% reduction in insomnia severity after 9 weeks, with 58.8% of patients achieving a meaningful improvement in their symptoms.

Over a two-year follow-up, patients experienced a 53% reduction in emergency department visits and an overall cost reduction of $510,678, averaging $2059 saved per patient, indicating that CBT-I can improve health outcomes and reduce healthcare costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-World Evaluation of Clinical Response and Long-Term Healthcare Resource Utilization Patterns Following Treatment with a Digital Therapeutic for Chronic Insomnia. Forma, F., Knight, TG., Thorndike, FP., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Insomnia and Information and Communication Technologies (ICT) in Elderly People: A Systematic Review. Salvemini, A., D'Onofrio, G., Ciccone, F., et al.[2020]

The Nitra application, an internet-based cognitive behavioral therapy for insomnia (CBT-i), significantly improved sleep efficiency and various sleep parameters in 40 adults with chronic subthreshold to moderate insomnia over a 4-week intervention period.

Participants who adhered closely to the recommended sleep schedule showed a higher likelihood of achieving normal sleep efficiency, highlighting the importance of consistent sleep habits in managing insomnia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of internet-based CBT-I for the treatment of chronic subthreshold to moderate insomnia. Theppornpitak, W., Hemrungrojn, S., Thienwiwatnukul, K., et al.[2023]

Cognitive behavior therapy (CBT) for insomnia is an effective nonpharmacologic intervention that can lead to reliable and sustained improvements in sleep patterns for patients suffering from chronic insomnia, which affects 10 to 30 percent of the population.

CBT includes various components such as cognitive psychotherapy, sleep hygiene, and relaxation techniques, typically delivered over four to eight weekly sessions, making it a recommended first-line treatment for chronic insomnia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nonpharmacologic management of chronic insomnia. Harsora, P., Kessmann, J.[2022]

A study involving 23 adults with asthma and insomnia showed that an Internet-based cognitive-behavioral therapy program (SHUTi) was feasible and well-accepted, with 83% completing the program.

Participants reported significant improvements in insomnia severity, sleep quality, asthma control, and asthma-related quality of life after using SHUTi, indicating its potential as an effective treatment for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet-Based Cognitive-Behavioral Therapy for Insomnia in Adults With Asthma: A Pilot Study. Luyster, FS., Ritterband, LM., Sereika, SM., et al.[2021]

A pilot study is being conducted to evaluate a 4-week tablet-based behavioral sleep intervention (MBSI) for older adults with mild cognitive impairment, aiming to improve insomnia symptoms without the use of medications.

The study will assess both immediate and sustained effects of the intervention on sleep quality and health-related quality of life, potentially offering a new non-pharmacological treatment option for this population.

NCBI (Pubmed)

pubmed.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. McPhillips, MV., Li, J., Petrovsky, DV., et al.[2023]

The SHUTi (Sleep Healthy Using The Internet) program, an interactive online intervention for insomnia, was rated highly by participants for its convenience and usefulness, with 95% reporting improvements in sleep and quality of life.

In a small sample of 21 participants, 90% perceived SHUTi as effective, suggesting that Internet-based cognitive-behavioral therapy could be a promising solution to address the lack of access to trained clinicians for insomnia treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and Perceived Utility and Impact of an Internet Intervention for Insomnia. Thorndike, FP., Saylor, DK., Bailey, ET., et al.[2022]

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