Enhanced CBTi for Older Adult Sleep and Cognition (R44)

The Pennsylvania State University (PENNSTATE)

Status and phase: Completed; Phase 3; Phase 2

Conditions: Insomnia; Alzheimers Disease Related Dementias

Treatments: Behavioral: CBTi; Behavioral: Sleep Hygiene Education; Combination Product: CBTi with Application

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05015803

R44AG056250

Details and patient eligibility

About

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).

Full description

Telehealth-delivered enhanced CBTi (integrated with a sleep diary app, a therapist dashboard, and data from IoT devices) will be compared to standard telehealth CBTi and to usual treatment with sleep hygiene education. The investigators will determine effects on insomnia (primary outcome) and on clinical sleep metrics (secondary outcome), among other outcomes including cognitive performance, blood biomarkers of ADRD, and therapeutic adherence.

After screening consent and qualification, informed consent, and adherence evaluation with ambulatory devices (1wk), study participants are pseudo-randomized into one of 3 study arms (2:2:1, Enhanced CBTi : Standard CBTi : Sleep Hygiene). The living space of participants is equipped with IoT data collection devices. Participants take surveys related to sleep, have blood drawn, wear ambulatory devices, complete cognitive evaluations, and interact with nearable living space devices and an iPhone interface during a preparation week leading up to an intake telehealth appointment. Baseline data collection (1wk) occurs. Participants then adhere to behavioral therapy directives prescribed at weekly telehealth sessions with a clinically qualified therapist, take surveys related to sleep, complete cognitive evaluations, wear ambulatory devices, and interact with nearable living space devices and an iPhone interface throughout the study intervention period of 6 weeks. During the final week (coinciding with the 6th intervention week), participants have a second blood draw and return all study equipment/devices at the conclusion of participation.

Enrollment: 60 patients

Sex: All

Ages: 60 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 3 patient groups

CBTi with Application

Experimental group

Description:

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

Treatment:

Combination Product: CBTi with Application

CBTi

Active Comparator group

Description:

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

Treatment:

Behavioral: CBTi

Sleep Hygiene

Active Comparator group

Description:

Treatment as usual: Sleep hygiene education and training.

Treatment:

Behavioral: Sleep Hygiene Education