Internet-Based Cognitive Behavioral Therapy for Insomnia and Mild Cognitive Impairment
Recruiting in Palo Alto (17 mi)
Age: 65+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: University of Virginia
Must not be taking: Opioids, Stimulants
Disqualifiers: Psychiatric treatment, Parkinson's, Chemotherapy, others
Prior Safety Data
Approved in 1 Jurisdiction
Trial Summary
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.
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.
12345Is 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.
34567How 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.
3891011Eligibility Criteria
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.
+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.
+13 more
Trial Timeline
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
Participant Groups
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.
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.
SHUTi OASIS is already approved in United States for the following indications:
🇺🇸 Approved in United States as SHUTi OASIS for:
- Insomnia
- Mild Cognitive Impairment
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of VirginiaCharlottesville, VA
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Who Is Running the Clinical Trial?
University of VirginiaLead Sponsor
References
Weekly brief phone support in self-help cognitive behavioral therapy for insomnia disorder: Relevance to adherence and efficacy. [2018]Self-help cognitive-behavioral therapy for insomnia (CBT-I) is an acceptable, low-intensity treatment in a stepped care model for insomnia. We tested the application of self-help CBT-I in a Chinese population. 312 participants with self-report of insomnia associated with distress or daytime impairment 3 or more nights per week for at least 3 months were randomized to self-help CBT-I with telephone support (SHS), self-help CBT-I (SH) and waiting-list (WL). The program was Internet-based with treatment materials delivered once per week, and lasted for 6 consecutive weeks, while the telephone support was limited to 15 min weekly. Mixed-effects analyses found significant group by time interaction in sleep and sleep-related cognitions at immediate and 4-week posttreatment. Post-hoc pairwise comparison with WL revealed that both SHS and SH had significantly higher sleep efficiency at immediate (p = .004 and p = .03, respectively) and 4-week posttreatment (p = .002 and p = .02, respectively) and lower insomnia and dysfunctional beliefs scores. The SHS group had additional improvements in sleep onset latency and sleep quality. Benefits with self-help CBT-I were maintained at 12-week posttreatment, but attrition rate was about 35%. Internet-based self-help CBT-I was effective and acceptable for treating insomnia in the Chinese population. A brief telephone support further enhanced the efficacy.
Insomnia and Information and Communication Technologies (ICT) in Elderly People: A Systematic Review. [2020]Background: Insomnia seems to be related to disability, risk of injury, metabolic syndrome, risk for cardiovascular diseases, cognitive impairment, depression and impaired quality of life. Objectives: The goals in this paper was (1) to keep track of technological concepts and approaches to improve insomnia in elderly people, and (2) to define the effect that information and communication technologies (ICT) is having on patients' care. Design: A systematic review was conducted from existing literature. Our selection criteria included: (1) age ≥ 60 years; (2) diagnosis of insomnia with the International Classification of Sleep Disorders (ICSD-II), (3) CBTi (cognitive behavioural therapy insomnia), (4) use of technological tools, and (5) associations between insomnia-related variables and indices of disability, quality of life, and global clinical assessments. Data analysis: 11 articles were included. An inductive content analysis was used for data extraction. Results: Our review revealed any technological systems that could purportedly rehabilitate elderly patients with insomnia. Three categories of research were identified from the review: (1) Internet Deliver-CBTi, (2) virtual coaches, and (3) sleep technologies. Conclusions: The potential for ICT to support insomnia care at home can improve the quality of life for families and reduce health care costs and premature institutional care.
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]Insomnia is a major health problem, and the need for effective and accessible treatment is urgent. The aim of the current study was to evaluate the short-term efficacy of an unguided Internet-based cognitive-behavioral treatment program for insomnia (CBTi), called SHUTi (Sleep Healthy Using the Internet).
Internet-Based Cognitive-Behavioral Therapy for Insomnia in Adults With Asthma: A Pilot Study. [2021]Background/Objective: Insomnia is common among adults with asthma and is associated with worse asthma control. Cognitive-behavioral therapy for insomnia (CBT-I) is an effective treatment for insomnia with medical comorbidities, but it has not been tested in asthma. The purpose of this study was to assess the feasibility and acceptability of an Internet-based CBT-I intervention, called Sleep Healthy Using the Internet (SHUTi), among adults with asthma and comorbid insomnia, and to gather preliminary efficacy data on changes in insomnia severity, sleep quality, asthma control, and asthma-related quality of life. Methods: A single-group, pretest-posttest design was employed, where all participants completed the SHUTi program. Online questionnaires were completed pre- and postintervention. Individual telephone interviews were conducted after posttreatment data collection to obtain participants' experiences with SHUTi and suggestions for improvement. Results: The sample (N = 23) comprised men and women aged 18-75 years with moderate to severe, not well-controlled asthma, and comorbid insomnia. Nineteen (83%) completed postintervention assessments. Improvements on the Insomnia Severity Index, Pittsburgh Sleep Quality Index, Asthma Control Test, and Asthma Quality of Life Questionnair-Marks were observed at postintervention. Data from the telephone interviews suggest that most participants had a positive experience with SHUTi. Participants suggested incorporating asthma-specific content into future versions of the intervention. Conclusions: Internet-based CBT-I is a potential treatment option for adults with asthma and comorbid insomnia.
Development and Perceived Utility and Impact of an Internet Intervention for Insomnia. [2022]Insomnia is a major health problem, with significant psychological, health, and economic consequences. Studies have demonstrated that cognitive-behavioural therapy can effectively treat insomnia; however, treatment availability is limited by many factors, including a lack of trained clinicians. One potential way to overcome these barriers is to use the Internet to deliver treatment. Toward this aim, we developed a self-guided, interactive, tailored Internet intervention for adults with insomnia (SHUTi: Sleep Healthy Using The Internet). The current paper provides a detailed description of SHUTi and examines users' perceptions of the intervention's usefulness and effectiveness. The study was part of a larger randomised controlled trial (RCT) to test the efficacy of SHUTi, but findings in this paper are based only on the 21 participants who completed the post-assessment after using SHUTi. The overwhelming majority rated SHUTi as convenient, understandable, and useful. Nearly all (95%) indicated that the program had at least somewhat improved their sleep, sleep efficiency, and overall quality of life. Ninety percent perceived the intervention as effective and predicted it would be effective in producing a long-term cure. Although these results were based on a small sample, they provide encouraging evidence of the potential for Internet interventions to be accepted by patients.
Real-World Evaluation of Clinical Response and Long-Term Healthcare Resource Utilization Patterns Following Treatment with a Digital Therapeutic for Chronic Insomnia. [2022]Label="Background and Objectives" NlmCategory="UNASSIGNED">This analysis evaluated insomnia severity and long-term impact on healthcare resource utilization (HCRU) and costs after treatment with Somryst® (previously called SHUTi), a digital therapeutic delivering cognitive behavioral therapy for insomnia (CBT-I).
Cognitive mechanisms of sleep outcomes in a randomized clinical trial of internet-based cognitive behavioral therapy for insomnia. [2019]The aim of this study was to investigate in a randomized clinical trial the role of sleep-related cognitive variables in the long-term efficacy of an online, fully automated cognitive behavioral therapy intervention for insomnia (CBT-I) (Sleep Healthy Using the Internet [SHUTi]).
Developing and Testing a Web-Based Provider Training for Cognitive Behavioral Therapy of Insomnia. [2021]Chronic insomnia is a common and debilitating disease that increases risk for significant morbidity and workplace difficulties. Cognitive behavioral therapy for insomnia (CBT-I) is the first-line treatment, but there is a critical lack of behavioral health providers trained in CBT-I because, in part, of a bottleneck in training availability and costs. The current project developed and evaluated a web-based provider training course for CBT-I: CBTIweb.org.
Nonpharmacologic management of chronic insomnia. [2022]Chronic insomnia is highly prevalent in our society, with an incidence of 10 to 30 percent. It is a major cost to society in terms of health care expenditure and reduced productivity. Nonpharmacologic interventions have been studied and shown to produce reliable and sustained improvements in sleep patterns of patients with insomnia. Cognitive behavior therapy for insomnia has multiple components, including cognitive psychotherapy, sleep hygiene, stimulus control, sleep restriction, paradoxical intention, and relaxation therapy. Cognitive psychotherapy involves identifying a patient's dysfunctional beliefs about sleep, challenging their validity, and replacing them with more adaptive substitutes. Sleep hygiene education teaches patients about good sleep habits. Stimulus control therapy helps patients to associate the bedroom with sleep and sex only, and not other wakeful activities. Sleep restriction therapy consists of limiting time in bed to maximize sleep efficiency. Paradoxical intention seeks to remove the fear of sleep by advising the patient to remain awake. Relaxation therapies are techniques taught to patients to reduce high levels of arousal that interfere with sleep. Cognitive behavior therapy involves four to eight weekly sessions of 60 to 90 minutes each, and should be used more frequently as initial therapy for chronic insomnia.
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]Insomnia symptoms in older adults with mild cognitive impairment represent a significant public health burden in terms of impaired quality of life, risks from untreated insomnia, and adverse effects from pharmaceutical insomnia treatment. To address current limitations in the most effective non-pharmacological treatments for insomnia in older adults with mild cognitive impairment, we are conducting a randomized pilot study to test a brief (4- week), tablet-based, personalized, multicomponent behavioral sleep intervention (MBSI) for insomnia, compared to a sleep education control, in a sample of older adults with mild cognitive impairment.
Effectiveness of internet-based CBT-I for the treatment of chronic subthreshold to moderate insomnia. [2023]To study the effectiveness of the first internet-based cognitive behavioral therapy for insomnia (CBT-i) in Thailand, using the Nitra application, for chronic subthreshold to moderate insomnia treatment.