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Sleep Healthy Using the Internet Mitigating Insomnia to Address Neurocognitive Difficulties (SHUTi MIND)

Primary Purpose

Insomnia, Cognitive Dysfunction, Mild Cognitive Impairment

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
SHUTi OASIS
Patient Education
Sponsored by
University of Virginia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia focused on measuring Insomnia, Alzheimer's disease, Mild cognitive impairment, Cognitive behavioral therapy

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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
  • Epilepsy
  • Irregular sleep schedule
  • Alcohol or drug abuse within the past year
  • Other untreated sleep disorders (e.g., obstructive sleep apnea)

Sites / Locations

  • University of VirginiaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

SHUTi OASIS

Patient Education Website

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Insomnia Severity Index
Change in overall insomnia severity

Secondary Outcome Measures

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
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
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
Paired Associates Learning
Changes in episodic memory will be measured using the Cambridge Neuropsychological Test Automated Battery (CANTAB) Paired Associates Learning
Sleep Efficiency
Amount of time spent asleep divided by the total time in bed

Full Information

First Posted
September 8, 2022
Last Updated
April 20, 2023
Sponsor
University of Virginia
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1. Study Identification

Unique Protocol Identification Number
NCT05565833
Brief Title
Sleep Healthy Using the Internet Mitigating Insomnia to Address Neurocognitive Difficulties (SHUTi MIND)
Official Title
Internet-based Insomnia Intervention to Prevent Cognitive Decline in Older Adults With Mild Cognitive Impairment (SHUTi MIND)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 27, 2023 (Actual)
Primary Completion Date
January 2028 (Anticipated)
Study Completion Date
January 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Virginia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia, Cognitive Dysfunction, Mild Cognitive Impairment, Sleep Initiation and Maintenance Disorders, Sleep Disorders, Intrinsic, Dyssomnias, Sleep Wake Disorders, Nervous System Diseases, Alzheimer Disease
Keywords
Insomnia, Alzheimer's disease, Mild cognitive impairment, Cognitive behavioral therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
144 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SHUTi OASIS
Arm Type
Experimental
Arm Description
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.
Arm Title
Patient Education Website
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
SHUTi OASIS
Intervention Description
Cognitive Behavioral Therapy for insomnia delivered online and metered out over 6-9 weeks in a fully automated, interactive, tailored web-based program
Intervention Type
Other
Intervention Name(s)
Patient Education
Intervention Description
An educational website containing information on insomnia
Primary Outcome Measure Information:
Title
Insomnia Severity Index
Description
Change in overall insomnia severity
Time Frame
Baseline, 9 weeks, 6 months, 12 months, 18 months, and 24 months
Secondary Outcome Measure Information:
Title
Wake after sleep onset (WASO)
Description
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
Title
Sleep onset latency (SOL)
Description
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
Title
Multidimensional Fatigue Symptoms Inventory - Short Form
Description
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
Title
Short Form-12 Health Survey (Quality of Life)
Description
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
Title
Match to Sample Visual Search
Description
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
Title
Spatial Working Memory Test
Description
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
Title
Paired Associates Learning
Description
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
Title
Sleep Efficiency
Description
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
Other Pre-specified Outcome Measures:
Title
Insomnia Knowledge Scale
Description
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
Title
Center for Epidemiologic Studies Depression Scale (CES-D)
Description
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
Title
Falls frequency
Description
Falls questionnaire including number and frequency of falls
Time Frame
Baseline, 9 weeks, 6 months, 12 months, 18 months, and 24 months
Title
Patient-Reported Outcomes Measurement Information System (PROMIS)
Description
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
Title
Self-Efficacy Scale- Insomnia-Specific
Description
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
Title
Lawson's Instrumental Activities of Daily Living Scale
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Meghan K Mattos, PhD, RN, CNL
Phone
434-243-3936
Email
ms2bv@virginia.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Meghan K Mattos, PhD, RN, CNL
Organizational Affiliation
University of Virginia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meghan Mattos, PhD
Phone
434-243-3936
Email
ms2bv@virginia.edu

12. IPD Sharing Statement

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Sleep Healthy Using the Internet Mitigating Insomnia to Address Neurocognitive Difficulties (SHUTi MIND)

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