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

NCT ID: NCT05565833

Last Updated: 2024-05-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 144 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-27
• Study Completion Date: 2028-01-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SHUTi OASIS

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.

Group Type: EXPERIMENTAL

SHUTi OASIS

Intervention Type: BEHAVIORAL

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

Patient Education Website

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.

Group Type: PLACEBO_COMPARATOR

Patient Education

Intervention Type: OTHER

An educational website containing information on insomnia

Interventions

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

Intervention Type: BEHAVIORAL

Patient Education

An educational website containing information on insomnia

Intervention Type: OTHER

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Virginia

OTHER

Sponsor Role: lead

Responsible Party

Meghan Mattos

Assistant Professor of Nursing

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Meghan K Mattos, PhD, RN, CNL

Role: PRINCIPAL_INVESTIGATOR

University of Virginia

Locations

University of Virginia

Charlottesville, Virginia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Meghan K Mattos, PhD, RN, CNL

Role: CONTACT

ms2bv@virginia.edu

434-243-3936

Facility Contacts

Meghan Mattos, PhD

Role: primary

ms2bv@virginia.edu

434-243-3936

Other Identifiers

IRB-HSR #220077

Identifier Type: -

Identifier Source: org_study_id