Cognitive Behavioral Therapy (CBT) for Disease

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Henry Ford Columbus Medical Center, Novi, MI
Disease+1 More
Cognitive Behavioral Therapy (CBT) - Behavioral
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

The purpose of this project is to test sleep reactivity as an independent cause of Shift Work Disorder (SWD). The primary hypothesis is that those with high sleep reactivity will show persistent SWD symptoms after experimental reduction of circadian misalignment, which will then be mitigated with CBT.

Eligible Conditions

  • Disease
  • Shift-work related sleep disturbance

Treatment Effectiveness

Study Objectives

2 Primary · 2 Secondary · Reporting Duration: Within two days of treatment for a duration of 24 hours

Within one week of post-treamtnet
Sleepiness
Within one week of post-treatment
Insomnia
Hour 24
Dim light melatonin onset
Within two weeks of treatment
Sleep reactivity

Trial Safety

Trial Design

4 Treatment Groups

Sleep education control condition
1 of 4
Control light condition
1 of 4
Active light condition
1 of 4
Cognitive Behavioral Therapy (CBT) condition
1 of 4
Active Control
Experimental Treatment

150 Total Participants · 4 Treatment Groups

Primary Treatment: Cognitive Behavioral Therapy (CBT) · No Placebo Group · N/A

Active light condition
Behavioral
Experimental Group · 1 Intervention: Active phototherapy · Intervention Types: Behavioral
Cognitive Behavioral Therapy (CBT) condition
Behavioral
Experimental Group · 1 Intervention: Cognitive Behavioral Therapy (CBT) · Intervention Types: Behavioral
Sleep education control condition
Behavioral
ActiveComparator Group · 1 Intervention: Sleep education control · Intervention Types: Behavioral
Control light condition
Behavioral
ActiveComparator Group · 1 Intervention: Control phototherapy · Intervention Types: Behavioral
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cognitive Behavioral Therapy (CBT)
2008
Completed Phase 4
~3620

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: within two days of treatment for a duration of 24 hours
Closest Location: Henry Ford Columbus Medical Center · Novi, MI
Photo of michigan 1Photo of michigan 2Photo of michigan 3
N/AFirst Recorded Clinical Trial
2 TrialsResearching Disease
0 CompletedClinical Trials

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)NIH
3,555 Previous Clinical Trials
46,915,039 Total Patients Enrolled
20 Trials studying Disease
17,951 Patients Enrolled for Disease
Henry Ford Health SystemLead Sponsor
257 Previous Clinical Trials
2,011,025 Total Patients Enrolled
3 Trials studying Disease
260 Patients Enrolled for Disease

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You must have Shift Work Disorder, which will be diagnosed based on ICSD-3 criteria.
Participants must show circadian misalignment, operationalized as a baseline melatonin onset between 18:00 and 01:00.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.