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

NCT05565833 | Recruiting Phase 2 DMC

• 1 other identifier: IRB-HSR #220077
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Insomnia Severity Index

  Change in overall insomnia severity

  Baseline, 9 weeks, 6 months, 12 months, 18 months, and 24 months

Secondary Outcomes (8)

• Wake after sleep onset (WASO)

  Baseline, 9 weeks, 6 months, 12 months, 18 months, and 24 months

• Sleep onset latency (SOL)

  Baseline, 9 weeks, 6 months, 12 months, 18 months, and 24 months

• Multidimensional Fatigue Symptoms Inventory - Short Form

  Baseline, 9 weeks, 6 months, 12 months, 18 months, and 24 months

• Short Form-12 Health Survey (Quality of Life)

  Baseline, 9 weeks, 6 months, 12 months, 18 months, and 24 months

• Match to Sample Visual Search

  Baseline, 9 weeks, 6 months, 12 months, 18 months, and 24 months

Other Outcomes (6)

• Insomnia Knowledge Scale

  Baseline, 9 weeks, 6 months, 12 months, 18 months, and 24 months

• Center for Epidemiologic Studies Depression Scale (CES-D)

  Baseline, 9 weeks, 6 months, 12 months, 18 months, and 24 months

• Falls frequency

  Baseline, 9 weeks, 6 months, 12 months, 18 months, and 24 months

Study Arms (2)

SHUTi OASIS

EXPERIMENTAL

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.

Behavioral: SHUTi OASIS

Patient Education Website

PLACEBO COMPARATOR

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.

Other: Patient Education

Interventions

SHUTi OASIS BEHAVIORAL

Cognitive Behavioral Therapy for insomnia delivered online and metered out over 6-9 weeks in a fully automated, interactive, tailored web-based program

SHUTi OASIS

Patient Education OTHER

An educational website containing information on insomnia

Patient Education Website

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22908, United States

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Cognitive Dysfunction; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Alzheimer Disease

Interventions

Patient Education as Topic

Condition Hierarchy (Ancestors)

Mental Disorders; Cognition Disorders; Neurocognitive Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Dementia; Brain Diseases; Central Nervous System Diseases; Tauopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Meghan K Mattos, PhD, RN, CNL

  University of Virginia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Meghan K Mattos, PhD, RN, CNL

CONTACT

434-243-3936; ms2bv@virginia.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Nursing

Study Record Dates

• First Submitted: September 8, 2022
• First Posted: October 4, 2022
• Study Start: February 27, 2023
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: May 8, 2024

Record last verified: 2024-05

Locations

US (1)