NCT05226585

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

Mechanisms of Change in Cognitive Behavioral Therapy for Insomnia (CBTi): A Randomized Controlled Pilot Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 93 (actual)
• Sponsor: University of Arizona · Academic / Other
• Sex: All
• Age: 50 Years – 65 Years
• Healthy volunteers: Not accepted

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).

Detailed description

Baseline Part 1: * Online demographic and contact information * Schedule Baseline Part 2 with the investigators via online link * 1 week of daily sleep diaries Baseline Part 2: * Internet-based interview with the investigators to confirm study eligibility requirements * Online self-report questionnaires * 2 weeks of daily sleep diaries * 2 weeks of sleep/wake assessment wearing a watch-like activity monitor (Actiwatch) Objective Baseline: * Single-night, diagnostic in-home sleep study, including and the following equipment: * Adhesive patch which will adhere to the arm * Sensor belts worn around the chest, fitted with nasal canula, pulse oximeter, and 3 electrodes which will adhere to the back of the neck and behind each ear * Next-day appointment: * Neuropsychological assessment * Structural and functional magnetic resonance imaging scan (MRI) * Non-invasive blood pressure readings * Low-volume Blood draw (used to obtain genetic biomarkers) * Removal of adhesive patch * Next-day evening (2-nights): * Consumable capsule * Sensor belt worn around the chest/abdomen Random Assignment: If it is determined the participant is eligible for the study, participants will be randomly assigned to one of the treatment groups (in-person, telehealth or internet delivered) or asked to wait to start treatment. Treatment Phase I: * Participants will complete up to 12 weeks of insomnia treatment or wait for treatment ("waitlist") 12-Week Post-treatment Part 1: * Complete 2 weeks of an online daily sleep diary and actigraphy * Complete online self-report questionnaires Objective 12-Week Post-treatment: • Repeat "Objective Baseline" outlined above Treatment Phase II (WLC): * Treatment will start for participants who had been assigned to the waitlist condition 3-Month Follow-Up: * Complete online self-report questionnaires

Conditions

• Sleep Initiation and Maintenance Disorders

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-09-26
• Primary completion: 2024-12-17
• Completion: 2024-12-17
• First posted: 2022-02-07
• Last updated: 2025-04-16

Locations

1 site across 1 country: United States