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NCT05453162 · ClinicalTrials.gov registry record · NA
Circadian Influence on Prolonged Exposure Therapy for PTSD
A NA study of PTSD, sponsored by Massachusetts General Hospital.
- Active
- Registry status
- NA
- Development phase
- 52
- Enrollment target
- 1
- Study location
NCT05453162: Active NA study of PTSD, sponsored by Massachusetts General Hospital.
NCT05453162 is a NA study of PTSD that is active but no longer recruiting, run by Massachusetts General Hospital. The registered enrollment target is 52 participants, below the 302-participant average among 154 other PTSD trials with a reported enrollment target (83% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05453162, a NA study of PTSD, is active but no longer recruiting, sponsored by Massachusetts General Hospital.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 52 participants
- Enrollment target
- 1
- Study location
Study Summary
Proposed research will examine time-of-day effects on trauma-related fear extinction using Prolonged Exposure Therapy (PE) telemedicine for Posttraumatic Stress Disorder (PTSD) in the National Center for PTSD (NCPTSD). The primary mechanistic outcome measure will be change in psychophysiological reactivity to script-driven imagery (SDI-PR) measured, in person, at pre-treatment, after 5 PE sessions (mid-treatment), and after all 10 PE sessions (post-treatment). A secondary mechanistic outcome will be session-to-session reduction in peak subjective units of distress (SUDS) ratings to imaginal exposures. The primary clinical outcome will be change in Clinican Administered PTSD Scale (CAPS-5) severity score; a secondary clinical outcome will be session-to-session reduction in self-reported PTSD symptoms using the PTSD checklist (PCL-5). Participants meeting inclusion criteria (described below) will be randomized to either PE sessions that begin from 07:00 to a time no later than 2 hours past a participant's customary rise time, or to the last treatment session of the day beginning at 16:00 or later (26 per arm). Participants will complete daily at-home imaginal-exposure homework within the same time frame as their PE sessions are scheduled, i.e., within 2 hours of awakening for morning (AM) group and between 16:00 and 2 hours before bedtime for late afternoon (PM) group.
Primary Outcome
This primary mechanistic outcome is a unitary discriminant canonical variable measuring psychophysiological reactivity while listening to personalized recorded scripts describing an index trauma.
Conditions Studied
Interventions
- BEHAVIORAL Prolonged Exposure Therapy for Posttraumatic Stress Disorder
Study Locations (1)
Massachusetts
- VA Boston Healthcare System - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2022-07-01 |
| Est. Completion | 2026-04-01 |
| Phase | NA |
What the registry record for NCT05453162 still lists
NCT05453162 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 302-participant average among 154 other PTSD trials with a reported enrollment target (83% lower).
The record links to 1 condition, with PTSD appearing as the primary indexed condition, and to 1 intervention - of which Prolonged Exposure Therapy for Posttraumatic Stress Disorder is the first listed.
NCT05453162 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT05453162 about?
NCT05453162 is a clinical study titled "Circadian Influence on Prolonged Exposure Therapy for PTSD". Proposed research will examine time-of-day effects on trauma-related fear extinction using Prolonged Exposure Therapy (PE) telemedicine for Posttraumatic Stress Disorder (PTSD) in the National Center for PTSD (NCPTSD). The primary mechanistic outcome measure will be change in psychophysiological rea...
What is the current status of trial NCT05453162?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 52 participants. The study started on 2022-07-01. Estimated completion is 2026-04-01.
What conditions does trial NCT05453162 study?
This clinical trial studies the following conditions: PTSD.
What interventions are being tested in trial NCT05453162?
The interventions under investigation include: Prolonged Exposure Therapy for Posttraumatic Stress Disorder (BEHAVIORAL).
Who is sponsoring clinical trial NCT05453162?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05453162 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05453162's enrollment target sits among peer trials
52 96th of 154 higher than 59 of 154 other PTSD trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other PTSD trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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