Enhanced CBTi for Older Adult Sleep and Cognition

NCT05015803 | Completed Phase 2

• 1 other identifier: R44AG056250
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized clinical trial on 60+ aged and independent-living healthy individuals with symptoms of insomnia will attempt to improve sleep and health outcomes related to sleep with enhancement of a clinical intervention, Cognitive Behavioral Therapy for Insomnia (CBTi).

Conditions

Insomnia; Alzheimers Disease Related Dementias

Keywords

cognitive-behavioral therapy (CBT); sleep; ADRD; insomnia

Outcome Measures

Primary Outcomes (1)

• Change in Insomnia Severity Index

  Subjective patient completion of the Insomnia Severity Index survey. Sum of survey item responses; Minimum score: 0; Maximum score: 28. Higher sum score indicates a greater number of, or more severe, insomnia symptoms; reduction in sum score suggests improvement of insomnia.

  Screening (at enrollment qualification) and Weekly (each of study weeks 1-8)

Secondary Outcomes (3)

• Change in Sleep Maintenance Efficiency

  Nightly (each night throughout study weeks 1-8)

• Change in Total Sleep Time

  Nightly (each night throughout study weeks 1-8)

• Change in Self-Reported Sleep

  Daily (each morning throughout study weeks 1-8)

Other Outcomes (4)

• Change in cognitive test battery performance

  Daily: Baseline (throughout 1st-2nd study weeks) and Post-Treatment (throughout 8th study week)

• Adherence to clinical therapeutic prescription

  Daily: during Intervention (throughout 3rd-7th study weeks) and Post-Treatment (throughout 8th study week)

• Change (pg/mL) in blood biomarkers of Alzheimer's-related dementia and Inflammation

  Baseline (week 2) vs. Post-Treatment (8th week)

Study Arms (3)

CBTi with Application

EXPERIMENTAL

Device-based intervention facilitation and clinician interfacing for Cognitive Behavioral Therapy for Insomnia (CBTi).

Combination Product: CBTi with Application

CBTi

ACTIVE COMPARATOR

Standard CBTi delivered via video conferencing \[Zoom Health\].

Behavioral: CBTi

Sleep Hygiene

ACTIVE COMPARATOR

Treatment as usual: Sleep hygiene education and training.

Behavioral: Sleep Hygiene Education

Interventions

CBTi with Application COMBINATION_PRODUCT

Participants randomized to this study arm will experience an attempted enhancement of standard video conferencing CBTi, that is facilitated with electronic device-based data and resources to the clinician. Noninvasive ambulatory worn and nearable devices deliver feedback of data to the clinician on an application interface. This information will be used to inform the therapeutic approach and to facilitate a living-space environment that is conducive to effective therapy.

Also known as: Cognitive-Behavioral Therapy for Insomnia - Enhanced

CBTi with Application

CBTi BEHAVIORAL

Participants randomized to this study arm will experience standard CBTi that is delivered via video conferencing by a clinician, with some application interface use.

Also known as: Cognitive-Behavioral Therapy for Insomnia - Standard

CBTi

Sleep Hygiene Education BEHAVIORAL

Participants randomized to this study arm will experience sleep hygiene education and training, with some application interface use.

Sleep Hygiene

Eligibility Criteria

• Age: 60 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Fluent English speaker/reader
• Resident of the state/commonwealth of Pennsylvania for tax purposes
• Ability to complete (sign) own consent form
• Age 60-90 (inclusive, at enrollment)
• Independent Living status (or equivalent; if dwelling in a community living facility)
• Insomnia Severity Index (ISI) screening survey score of \>=11
• Willing to refrain from initiating new therapeutic insomnia interventions that are not a part of this study protocol for the duration of study participation
• Willing to maintain existing physician-directed intervention for issues pertaining to sleep for the duration of study participation
• Has a residence with access to WiFi

You may not qualify if:

• Has a pacemaker
• Illicit drug use in the past month
• Diagnosed serious mental health disorder (e.g. psychosis or bipolar depression)
• Currently engaged in evidence-based psychotherapy for Insomnia (e.g. CBTi)
• Cohabiting with a current or previous participant in this study
• Evidence of Cognitive Impairment (a score of \<18 on the abbreviated Montreal Cognitive Assessment \[MoCA\] screening evaluation)

Sponsors & Collaborators

• Penn State University: lead
• University of Arizona: collaborator
• Proactive Life Inc: collaborator

Study Sites (1)

The Pennsylvania State University

University Park, Pennsylvania, 16802, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Daniel Taylor, Ph.D.

  The University of Arizona

  PRINCIPAL INVESTIGATOR

• Daniel Gartenberg, Ph.D.

  Sleep Space, Inc.

  PRINCIPAL INVESTIGATOR

• Orfeu M Buxton, Ph.D.

  The Pennsylvania State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: This is a single-blind study design. The therapeutic care for insomnia is synonymous with the study intervention, therefore blinding of the CBT care provider is impossible.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Elizabeth Fenton Susman Professor of Biobehavioral Health

Model Details: CBTi with Application, Standard TeleHealth CBTi, and Sleep Hygiene Education study groups run in parallel after randomization.

Study Record Dates

• First Submitted: July 16, 2021
• First Posted: August 20, 2021
• Study Start: March 16, 2022
• Primary Completion: June 14, 2023
• Study Completion: August 16, 2023
• Last Updated: April 12, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)