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

Sleep Initiation and Maintenance Disorders Clinical Trial

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

Status Recruiting

Clinical Trial 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).

Clinical Trial 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 ;

Related Conditions & MeSH terms

• Sleep Initiation and Maintenance Disorders

• NCT number: NCT05226585
• Study type: Interventional
• Source: University of Arizona
• Contact: Ethan Olson
• Phone: 520-621-8366
• Email: ethanadamolson@arizona.edu
• Status: Recruiting
• Phase: N/A
• Start date: October 21, 2021
• Completion date: December 31, 2024