Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05453162
The ClinicalTrials.gov registry entry for NCT05453162 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 52 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 302-participant average among 154 other PTSD trials with a reported enrollment target (83% lower). The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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
Similar trials for PTSD
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Testing an Integrated PTSD and Weight Management Intervention: A Hybrid Type 1 Trial
RECRUITING · NA
-
Treatments for Insomnia in Veterans With PTSD
RECRUITING · NA
-
REstoring Mental Health Through COmmUnity-based Psychological Services in New York City
RECRUITING · NA
-
Recovery Through Inhibitory Learning, Self-Efficacy Building, Problem Solving, and Community Building
RECRUITING · NA
-
Project Safe Guard-Trauma
RECRUITING · NA
-
Neuromodulation of the Fear Extinction Circuit Using Temporally and Anatomically Specific TMS in Humans
RECRUITING · NA
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.