Alzheimer Disease Clinical Trial
Official title:
Internet-based Insomnia Intervention to Prevent Cognitive Decline in Older Adults With Mild Cognitive Impairment (SHUTi MIND)
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.
Status | Recruiting |
Enrollment | 144 |
Est. completion date | January 2028 |
Est. primary completion date | January 2028 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 65 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Virginia | Charlottesville | Virginia |
Lead Sponsor | Collaborator |
---|---|
University of Virginia |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Insomnia Knowledge Scale | Sleep knowledge and cognitive behavioral therapy for insomnia techniques; scores range from 0-10 and higher scores indicate greater insomnia knowledge | Baseline, 9 weeks, 6 months, 12 months, 18 months, and 24 months | |
Other | 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 | Baseline, 9 weeks, 6 months, 12 months, 18 months, and 24 months | |
Other | Falls frequency | Falls questionnaire including number and frequency of falls | Baseline, 9 weeks, 6 months, 12 months, 18 months, and 24 months | |
Other | 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. | Baseline, 9 weeks, 6 months, 12 months, 18 months, and 24 months | |
Other | 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. | Baseline, 9 weeks, 6 months, 12 months, 18 months, and 24 months | |
Other | 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). | Baseline, 9 weeks, 6 months, 12 months, 18 months, and 24 months | |
Primary | Insomnia Severity Index | Change in overall insomnia severity | Baseline, 9 weeks, 6 months, 12 months, 18 months, and 24 months | |
Secondary | 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 | Baseline, 9 weeks, 6 months, 12 months, 18 months, and 24 months | |
Secondary | 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 | Baseline, 9 weeks, 6 months, 12 months, 18 months, and 24 months | |
Secondary | 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 | Baseline, 9 weeks, 6 months, 12 months, 18 months, and 24 months | |
Secondary | 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 | Baseline, 9 weeks, 6 months, 12 months, 18 months, and 24 months | |
Secondary | 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 | Baseline, 9 weeks, 6 months, 12 months, 18 months, and 24 months | |
Secondary | 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 | Baseline, 9 weeks, 6 months, 12 months, 18 months, and 24 months | |
Secondary | Paired Associates Learning | Changes in episodic memory will be measured using the Cambridge Neuropsychological Test Automated Battery (CANTAB) Paired Associates Learning | Baseline, 9 weeks, 6 months, 12 months, 18 months, and 24 months | |
Secondary | Sleep Efficiency | Amount of time spent asleep divided by the total time in bed | Baseline, 9 weeks, 6 months, 12 months, 18 months, and 24 months |
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