Other Clinical Trial - Mechanisms of Change in Cognitive Behavioral

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 ;

Study Design

Related Conditions & MeSH terms

Sleep Initiation and Maintenance Disorders

Clinical Trial Details

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	October 2023

View Details

See also
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Completed	`NCT03673397` - The Acute Effect of Aerobic Exercise on Sleep in Patients With Depression	N/A
Completed	`NCT01784614` - A Study of LY2624803 in Japanese Participants With Transient Insomnia	Phase 1
Completed	`NCT00365261` - Effect of Eszopiclone on Sleep Disturbance and Pain in Cancer	Phase 4
Completed	`NCT00380003` - Efficacy Study of EVT 201 to Treat Insomnia	Phase 2
Completed	`NCT00183378` - Using Behavioral Programs to Treat Sleep Problems in Individuals With Alzheimer's Disease	N/A
Completed	`NCT00946530` - Light Treatment for Sleep/Wake Disturbances in Alzheimer's Disease	N/A
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Completed	`NCT00630175` - Evaluation of the Hypnotic Properties of Zolpidem-MR 12.5 mg and Zolpidem 10 mg Marketed Product Compared to Placebo in Patients With Primary Insomnia	Phase 3
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Completed	`NCT00079664` - Comparing Tai Chi Training to a Low-Stress Physical Activity to Enhance Sleep in Older Adults	Phase 1
Completed	`NCT01154023` - Behavioral Intervention for Insomnia in Older Adults	N/A
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Enrolling by invitation	`NCT04986007` - Addressing Nocturnal Sleep/Wake Effects on Risk of Suicide in Older Adults	N/A
Completed	`NCT03852966` - Better Sleep in Psychiatric Care - ADHD Pilot Study	N/A
Terminated	`NCT00750919` - Twenty-six Week Extension Trial of Org 50081 (Esmirtazapine) in Outpatients With Chronic Primary Insomnia (176003/P05721/MK-8265-007)	Phase 3
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms