Late afternoon PE for Post-Traumatic Stress Disorder

VA Boston Healthcare System, Boston, MA
Post-Traumatic Stress DisorderProlonged Exposure Therapy for Posttraumatic Stress Disorder - Behavioral
25 - 45
All Sexes
What conditions do you have?

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.

Eligible Conditions
  • Post Traumatic Stress Disorder

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3

Study Objectives

4 Primary · 4 Secondary · Reporting Duration: Day 63 PCL-5 score at PE therapy session 10

Between days -7 to -1, Baseline
Clinician-Administered PTSD scale for Diagnostic and Statistical Manual of Mental Disorders (DSM), Fifth Edition (CAPS-5): Primary Clinical Outcome
Between days 29-34, mid-treatment
Psychophysiological reactivity to script-driven imagery (SDI-PR): Primary Mechanistic Outcome
Between days 64-71, post-treatment
CAPS-5: Primary Clinical Outcome
Psychophysiological reactivity to script-driven imagery (SDI-PR: )Primary Mechanistic Outcome
Day 0
Mental disorders
Day 14
Subjective Units of Distress (SUDS): Secondary Mechanistic Outcome
Day 63
PCL-5: Secondary Clinical Outcome
Day 63
SUDS: Secondary Mechanistic Outcome

Trial Safety

Phase-Based Safety

1 of 3

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

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

Late afternoon PE
Experimental Group · 1 Intervention: Prolonged Exposure Therapy for Posttraumatic Stress Disorder · Intervention Types: Behavioral
Early morning PE
Experimental Group · 1 Intervention: Prolonged Exposure Therapy for Posttraumatic Stress Disorder · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: day 63 pcl-5 score at pe therapy session 10

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,778 Previous Clinical Trials
31,224,631 Total Patients Enrolled
VA Boston Healthcare SystemFED
65 Previous Clinical Trials
970,235 Total Patients Enrolled
National Institute of Mental Health (NIMH)NIH
2,616 Previous Clinical Trials
1,982,875 Total Patients Enrolled
Suzanne L Pineles, PhDPrincipal InvestigatorVA Boston Health System, Boston University
Edward F Pace-Schott, PhDPrincipal InvestigatorMassachusetts General Hospital
1 Previous Clinical Trials
30 Total Patients Enrolled

Eligibility Criteria

Age 25 - 45 · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have expressed a desire to begin a course of PE (physical education).
You scored in the middle range (42-58) on the Morningness-Eveningness Questionnaire (MEQ), which measures if you are a morning or evening person.
The study is only open to people who have served in the military.

Who else is applying?

What state do they live in?
What site did they apply to?
VA Boston Healthcare System100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%

How responsive is this trial?

Typically responds via
Phone Call100.0%
Average response time
  • < 2 Days
Most responsive sites:
  1. VA Boston Healthcare System: < 48 hours

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

Unverified Answer

Are opportunities still present to join the experiment?

"According to the 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

Unverified Answer

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

Unverified Answer

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

Unverified Answer

How many individuals have been chosen to participate in this experiment?

"That is correct. 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

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.