About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Provision of signed and dated informed consent form
Stated willingness to comply with all study procedures and availability for the duration of the study
Male or female, aged ≥ 65 years of age.
Able to speak and read English, and is a US resident.
Disqualifiers
Current psychological treatment for insomnia
Initiation of psychological or psychiatric treatment within the past three months
Current diagnosis of Huntington's or Parkinson's disease
Current treatment for hyperthyroidism
Trial design
Parallel
Treatments tested in this trial
SHUTi OASIS
BehavioralCognitive Behavioral Therapy for insomnia delivered online and metered out over 6-9 weeks in a fully automated, interactive, tailored web-based program
Patient Education
Other interventionAn educational website containing information on insomnia
Treatment groups
Trial outcomes
Primary outcomes
Insomnia Severity Index
Change in overall insomnia severity
Secondary outcomes
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
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
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
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
Other outcomes
Insomnia Knowledge Scale
Sleep knowledge and cognitive behavioral therapy for insomnia techniques; scores range from 0-10 and higher scores indicate greater insomnia knowledge
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
Falls frequency
Falls questionnaire including number and frequency of falls
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.
Sponsors and contacts
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