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Mechanisms of Change in Cognitive Behavioral Therapy for Insomnia (CBTi)

NCT05226585 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 93

Last updated 2025-04-16

No results posted yet for this study

Summary

The purpose of this study is to investigate the mechanisms of change in Cognitive Behavioral Therapy for insomnia (CBTi) in a sample of adults aged 50-65. This study aims to evaluate the pre-post treatment change in sleep, circadian rhythms, biomarkers, cognitive performance, and structural and functional magnetic resonance imaging scans (MRI).

Conditions

  • Sleep Initiation and Maintenance Disorders

Interventions

BEHAVIORAL

In-Person Cognitive Behavioral Therapy for Insomnia

Cognitive behavioral therapy is recommended as a first-line treatment for insomnia (CBTi). CBTi contains the following well-validated components of cognitive behavioral treatment for insomnia: stimulus control, sleep compression, sleep hygiene, relaxation training, and cognitive restructuring.

BEHAVIORAL

Telehealth Cognitive Behavioral Therapy for Insomnia

Telehealth cognitive behavioral therapy is recommended as a first-line treatment for insomnia (CBTi) conducted via audio-video communication. tCBTi contains the following well-validated components of cognitive-behavioral treatment for insomnia: stimulus control, sleep compression, sleep hygiene, relaxation training, and cognitive restructuring.

BEHAVIORAL

Internet Cognitive Behavioral Therapy for Insomnia

Sleep Healthy Using The Internet (SHUTi; aka iCBTi) is a self-guided, fully automated, online CBTi program that includes interactive features: personalized goal setting, graphical feedback based on inputted data, animations/illustrations to enhance comprehension, patient vignettes, and video-based expert explanations.

Sponsors & Collaborators

  • University of Arizona

    lead OTHER

Principal Investigators

  • Daniel J Taylor, Ph.D. · The University of Arizona

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-26
Primary Completion
2024-12-17
Completion
2024-12-17

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05226585 on ClinicalTrials.gov