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

Alzheimer Disease Clinical Trial

Official title:

Internet-based Insomnia Intervention to Prevent Cognitive Decline in Older Adults With Mild Cognitive Impairment (SHUTi MIND)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05565833
• Other study ID #: IRB-HSR #220077
• Status: Recruiting
• Phase: Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognitive Dysfunction
• Dyssomnias
• Insomnia
• Mild Cognitive Impairment
• Nervous System Diseases
• Sleep Disorders, Intrinsic
• Sleep Initiation and Maintenance Disorders
• Sleep Wake Disorders

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