Study Summary
This trial will study the effect of time of day on treating PTSD with Prolonged Exposure Therapy via telemedicine. Outcomes measured include psychophysiological & clinical changes. Participants will be randomized to morning or late afternoon sessions with daily imaginal-exposure homework.
- Post Traumatic Stress Disorder
Treatment Effectiveness
Phase-Based Effectiveness
Study Objectives
4 Primary · 4 Secondary · Reporting Duration: Day 63 PCL-5 score at PE therapy session 10
Trial Safety
Phase-Based Safety
Awards & Highlights
Trial Design
2 Treatment Groups
Late afternoon PE
1 of 2
Early morning PE
1 of 2
Experimental Treatment
52 Total Participants · 2 Treatment Groups
Primary Treatment: Late afternoon PE · No Placebo Group · N/A
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 25 - 45 · All Participants · 3 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Who else is applying?
What state do they live in?
| Quebec | 100.0% |
What site did they apply to?
| VA Boston Healthcare System | 100.0% |
What portion of applicants met pre-screening criteria?
| Did not meet criteria | 100.0% |
How responsive is this trial?
Typically responds via
| Phone Call | 100.0% |
Average response time
- < 2 Days
Most responsive sites:
- VA Boston Healthcare System: < 48 hours
- Meuret AE, Trueba AF, Abelson JL, Liberzon I, Auchus R, Bhaskara L, Ritz T, Rosenfield D. High cortisol awakening response and cortisol levels moderate exposure-based psychotherapy success. Psychoneuroendocrinology. 2015 Jan;51:331-40. doi: 10.1016/j.psyneuen.2014.10.008. Epub 2014 Oct 16.
- Meuret AE, Rosenfield D, Bhaskara L, Auchus R, Liberzon I, Ritz T, Abelson JL. Timing matters: Endogenous cortisol mediates benefits from early-day psychotherapy. Psychoneuroendocrinology. 2016 Dec;74:197-202. doi: 10.1016/j.psyneuen.2016.09.008. Epub 2016 Sep 15.
- Pace-Schott EF, Germain A, Milad MR. Effects of sleep on memory for conditioned fear and fear extinction. Psychol Bull. 2015 Jul;141(4):835-57. doi: 10.1037/bul0000014. Epub 2015 Apr 20. Review.
- Brueckner AH, Lass-Hennemann J, Wilhelm FH, Ferreira de Sá DS, Michael T. Cortisol administration after extinction in a fear-conditioning paradigm with traumatic film clips prevents return of fear. Transl Psychiatry. 2019 Apr 8;9(1):128. doi: 10.1038/s41398-019-0455-0.
- Pace-Schott EF, Spencer RM, Vijayakumar S, Ahmed NA, Verga PW, Orr SP, Pitman RK, Milad MR. Extinction of conditioned fear is better learned and recalled in the morning than in the evening. J Psychiatr Res. 2013 Nov;47(11):1776-84. doi: 10.1016/j.jpsychires.2013.07.027. Epub 2013 Aug 28.
- Pace-Schott EF, Germain A, Milad MR. Sleep and REM sleep disturbance in the pathophysiology of PTSD: the role of extinction memory. Biol Mood Anxiety Disord. 2015 May 29;5:3. doi: 10.1186/s13587-015-0018-9. eCollection 2015.
- Brueckner AH, Lass-Hennemann J, Wilhelm FH, Ferreira de Sa DS, Michael T. Cortisol administration after extinction in a fear-conditioning paradigm with traumatic film clips prevents return of fear. Transl Psychiatry. 2019 Apr 8;9(1):128. doi: 10.1038/s41398-019-0455-0.
- Pace-Schott EF, Germain A, Milad MR. Effects of sleep on memory for conditioned fear and fear extinction. Psychol Bull. 2015 Jul;141(4):835-57. doi: 10.1037/bul0000014. Epub 2015 Apr 20.
- Edward F. Pace-Schott 2022. "Circadian Influence on Prolonged Exposure Therapy for PTSD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05453162.
Frequently Asked Questions
Is this research endeavor extending its recruitment efforts to those over eighty-five years old?
"This clinical trial is trying to find participants aged between 25 and 45." - Anonymous Online Contributor
Are opportunities still present to join the experiment?
"According to the clinicaltrials.gov website, this medical trial is currently in its recruitment phase and has been since it was first posted on July 1st 2022. The last update occurred February 25th 2023." - Anonymous Online Contributor
Who is qualified to join this experiment?
"This medical trial requires participants to have a diagnosis of post traumatic stress disorder and be aged 25-45. 52 individuals are required for the study's completion." - Anonymous Online Contributor
What are the chief aims of this clinical research endeavor?
"This trial's primary aim is to evaluate the psychophysiological reactivity of participants in response to script-driven imagery over a period of 64-71 days post-treatment. Secondary objectives include measuring symptoms of PTSD using PCL-5 and Subjective Units of Distress (SUDS) scales, which range from 0 (no distress) to 100 (extreme distress)." - Anonymous Online Contributor
How many individuals have been chosen to participate in this experiment?
"That is correct. Clinicaltrials.gov data affirms that this research, which was originally posted on July 1st 2022, is actively pursuing patients. Approximately 52 participants must be recruited from a single site." - Anonymous Online Contributor