A Phase 2 interventional study of SHUTi OASIS and Patient Education in Insomnia, Cognitive Dysfunction and Mild Cognitive Impairment, sponsored by University of Virginia. Recruiting at 1 site in United States. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2024-05-08.
Sponsored by University of Virginia · Phase 2, Interventional, and Treatment
This randomized controlled trial will evaluate the impact of an Internet-delivered cognitive behavioral therapy for insomnia (CBT-I) intervention on sleep and the extent to which it contributes to cognitive health in individuals with mild cognitive impairment. Participants with insomnia who meet the study criteria for mild cognitive impairment will be recruited to determine the effects of the CBT-I intervention compared to a patient education condition on sleep and cognition. Internet-based recruitment methods will be used, and outcomes include sleep variables, daytime variables, and cognitive status.
This randomized controlled trial will evaluate the impact of an Internet-delivered cognitive behavioral therapy for insomnia (CBT-I) intervention on sleep and the extent to which it contributes to cognitive health in individuals with mild cognitive impairment. Participants with insomnia who meet the study criteria for mild cognitive impairment will be recruited to determine the effects of the CBT-I intervention compared to patient education (PE) control condition on sleep and cognition. Internet-based recruitment methods will be used, and outcomes include sleep variables (reduced overall insomnia severity and wake after sleep onset), daytime variables (reduced levels of fatigue, improved quality of life, and improved mood), and cognitive status (memory, attention/psychomotor speed, and executive functioning domains). Participants will complete a pre-assessment battery, which consists of an online cognitive test, an online questionnaire, and two weeks of sleep diaries. Once complete, participants will be randomized to either the Internet-based PE or CBT-I intervention. At the start of week nine, all participants will be instructed to complete the post-assessment battery (cognitive test, questionnaires, and diaries). After completing the post-assessment, participants will have continued access to their assigned online program throughout the study duration. This same assessment (cognitive test, questionnaires, and diaries) will be completed at 6, 12, 18, and 24 months.
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Exclusion Criteria:
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.
Behavioral: SHUTi OASIS
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.
Other: Patient Education
Cognitive Behavioral Therapy for insomnia delivered online and metered out over 6-9 weeks in a fully automated, interactive, tailored web-based program
An educational website containing information on insomnia
Insomnia Severity Index
Change in overall insomnia severity
Time frame: Baseline, 9 weeks, 6 months, 12 months, 18 months, and 24 months
Wake after sleep onset (WASO)
Change in periods of wakefulness occurring after defined sleep onset as measured by daily sleep diaries over 10-14 day periods, measured in minutes, collected through sleep diary entries
Time frame: Baseline, 9 weeks, 6 months, 12 months, 18 months, and 24 months
Sleep onset latency (SOL)
Change in length of time that it takes to transition from wakefulness to sleep, measured in minutes, collected through sleep diary entries
Time frame: Baseline, 9 weeks, 6 months, 12 months, 18 months, and 24 months
Multidimensional Fatigue Symptoms Inventory - Short Form
Change in self-report measures of five dimensions of fatigue ( general fatigue, physical fatigue, emotional fatigue, mental fatigue, and vigor) measured using Multidimensional Fatigue Symptoms Inventory-Short Form. Total MFSI-SF scores range from 24 to 96, with a higher score indicating a higher fatigue level
Time frame: Baseline, 9 weeks, 6 months, 12 months, 18 months, and 24 months
Short Form-12 Health Survey (Quality of Life)
The SF-12 Health Survey will be used to measure changes in physical and mental quality of life. Scores range from 0 to 100, with higher scores indicating better physical and mental health
Time frame: Baseline, 9 weeks, 6 months, 12 months, 18 months, and 24 months
Match to Sample Visual Search
Changes in attention and processing speed will be measured using the Cambridge Neuropsychological Test Automated Battery (CANTAB) Match to Sample Visual Search
Time frame: Baseline, 9 weeks, 6 months, 12 months, 18 months, and 24 months
Spatial Working Memory Test
Changes in working memory and executive function will be measured using the Cambridge Neuropsychological Test Automated Battery (CANTAB) Spatial Working Memory Test
Time frame: Baseline, 9 weeks, 6 months, 12 months, 18 months, and 24 months
Paired Associates Learning
Changes in episodic memory will be measured using the Cambridge Neuropsychological Test Automated Battery (CANTAB) Paired Associates Learning
Time frame: Baseline, 9 weeks, 6 months, 12 months, 18 months, and 24 months
Sleep Efficiency
Amount of time spent asleep divided by the total time in bed
Time frame: Baseline, 9 weeks, 6 months, 12 months, 18 months, and 24 months
Insomnia Knowledge Scale
Sleep knowledge and cognitive behavioral therapy for insomnia techniques; scores range from 0-10 and higher scores indicate greater insomnia knowledge
Time frame: Baseline, 9 weeks, 6 months, 12 months, 18 months, and 24 months
Center for Epidemiologic Studies Depression Scale (CES-D)
Depression and anxiety are measured using the Center for Epidemiologic Studies Depression Scale (CES-D). Scores range from 0-60, where higher scores indicate greater likelihood of depression
Time frame: Baseline, 9 weeks, 6 months, 12 months, 18 months, and 24 months
Falls frequency
Falls questionnaire including number and frequency of falls
Time frame: Baseline, 9 weeks, 6 months, 12 months, 18 months, and 24 months
Patient-Reported Outcomes Measurement Information System (PROMIS)
Pain intensity and interference are measured using PROMIS Pain Intensity questions. On a scale of 0-100, a score of 50 is considered the mean/reference population, and higher scores indicate greater pain intensity.
Time frame: Baseline, 9 weeks, 6 months, 12 months, 18 months, and 24 months
Self-Efficacy Scale- Insomnia-Specific
Global-, task-, and self-regulation self-efficacy changes are measured using Self-Efficacy Scale developed by Bouchard, Bastien \& Morin (2010) and includes 40 questions. Questions are answered using a scale from 0 (can't do at all) to 100 (absolutely certain can do), where higher scores indicate higher self-efficacy.
Time frame: Baseline, 9 weeks, 6 months, 12 months, 18 months, and 24 months
Lawson's Instrumental Activities of Daily Living Scale
Activities that allow an individual to live independently in a community. Score range from 0 (low function, dependent) to 8 (high function, independent).
Time frame: Baseline, 9 weeks, 6 months, 12 months, 18 months, and 24 months
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