Cognitive Behavioral Therapy for Insomnia in Older Adults
Sleep Healthy Using the Internet Mitigating Insomnia to Address Neurocognitive Difficulties (SHUTi MIND)
Recruiting
Phase 2Interventional Study
InsomniaCognitive DysfunctionMild Cognitive ImpairmentSleep Initiation and Maintenance DisordersSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesAlzheimer Disease
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
65 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
144 (estimated)
Sponsor
University of Virginia · Other
Who this trial is looking for
This trial is looking for older adults with sleep problems and mild cognitive impairment. Participants will receive online therapy for insomnia or education about sleep to see how it affects their sleep and thinking.
Are You a Good Fit for This Trial?
Rules you outHuntington's diseaseParkinson's diseaseHyperthyroidismChemotherapyAsthmaChronic painEpilepsyPsychotic disorder
You may be able to join if
I am at least 65 years old.
I can speak and read English.
I have insomnia symptoms.
I have experienced significant distress from my sleep issues.
I have mild cognitive impairment.
I can use the Internet and receive emails about the study.
I am stable on my medications.
You may not be able to join if
I am currently receiving psychological treatment for insomnia.
I have been treated for Huntington's or Parkinson's disease.
I am currently undergoing chemotherapy.
I have untreated asthma or respiratory issues at night.
I have chronic pain treated with opioids.
I have epilepsy without stable treatment for at least 3 months.
I have an irregular sleep schedule.
I have a current diagnosis of a psychotic or bipolar disorder.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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-…
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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 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.
* Have access to any In…
Inclusion Criteria:
* 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.
* Have access to any Internet-enabled device (computer, tablet, smartphone) and willing to be emailed about the study.
* Sleep-onset insomnia and/or sleep maintenance insomnia symptoms
* The sleep disturbance (or associated daytime fatigue) causes significant distress or impairment in social, occupational, or other areas of functioning over the past three months.
* Cognitive impairment through study assessment.
* Stable medication regimen unless medication is known to cause insomnia
Exclusion Criteria:
* 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
* Currently undergoing chemotherapy
* Presence of asthma or respiratory concerns with night treatment
* Chronic pain treated with opioids
* Not recovered from a brain tumor, injury, or infection
* Epilepsy without stable treatment for at least 3 months
* Irregular sleep schedule
* Use of stimulating medications after 5pm or taken for less than 3 months
* Psychotic or bipolar disorder
* Moderate to high risk of suicide
* Alcohol or drug abuse within the past year
* Other untreated sleep disorders (e.g., obstructive sleep apnea)
* Study screen for severe depression
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