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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05565833
Other study ID # IRB-HSR #220077
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date February 27, 2023
Est. completion date January 2028

Study information

Verified date May 2024
Source University of Virginia
Contact Meghan K Mattos, PhD, RN, CNL
Phone 434-243-3936
Email ms2bv@virginia.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

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

Study Design


Intervention

Behavioral:
SHUTi OASIS
Cognitive Behavioral Therapy for insomnia delivered online and metered out over 6-9 weeks in a fully automated, interactive, tailored web-based program
Other:
Patient Education
An educational website containing information on insomnia

Locations

Country Name City State
United States University of Virginia Charlottesville Virginia

Sponsors (1)

Lead Sponsor Collaborator
University of Virginia

Country where clinical trial is conducted

United States, 

Outcome

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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