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NCT05788302 · ClinicalTrials.gov registry record · NA
Mechanisms Underlying Efficacy of Prolonged Exposure
A NA study of Post Traumatic Stress Disorder, sponsored by Massachusetts General Hospital.
- Recruiting
- Registry status
- NA
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT05788302: Recruiting NA study of Post Traumatic Stress Disorder, sponsored by Massachusetts General Hospital.
NCT05788302 is a NA study of Post Traumatic Stress Disorder that is actively recruiting participants, run by Massachusetts General Hospital. The registered enrollment target is 50 participants, below the 664-participant average among 262 other Post Traumatic Stress Disorder trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05788302, a NA study of Post Traumatic Stress Disorder, is actively recruiting participants, sponsored by Massachusetts General Hospital.
- RECRUITING
- Registry status
- NA
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study Summary
The primary objective of this research is to collect pilot data that demonstrates that proposed neural, psychophysiological and subjective markers measured before, during, and after treatment change over the course of Prolonged Exposure therapy (PE) for posttraumatic stress disorder (PTSD). The aims of the study are to: (1) examine theoretically informed mechanisms as pretreatment predictors of PE treatment efficacy, (2) characterize how neural, psychophysiological, and subjective markers measured before, during, and after treatment change over the course of PE, and (3) examine proposed mechanisms of change as measures of PE treatment efficacy. This is a longitudinal study of predictors of exposure therapy efficacy that will be conducted within the context of a standard 10 session PE treatment trial, with independent multimodal assessment batteries administered at pre-treatment, mid-treatment, post-treatment, and at 1-month follow-up. This data will be used to support a future NIMH and/or VA grant submission.
Primary Outcome
The primary clinical outcome, CAPS-5, is the gold standard clinical interview for assessing PTSD severity. In CAPS-5, each of the 20 symptoms of PTSD is rated on a 5-point severity scale ranging from 0 (absent) to 4 (extreme). Total scores range from 0 to 80.
Conditions Studied
Interventions
- BEHAVIORAL Prolonged Exposure
Study Locations (1)
Massachusetts
- MGH - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2023-04-01 |
| Est. Completion | 2027-12-01 |
| Phase | NA |
What NCT05788302 shows while recruiting
NCT05788302 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 664-participant average among 262 other Post Traumatic Stress Disorder trials with a reported enrollment target (92% lower).
The record links to 1 condition, with Post Traumatic Stress Disorder appearing as the primary indexed condition, and to 1 intervention - of which Prolonged Exposure is the first listed.
NCT05788302 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT05788302 about?
NCT05788302 is a clinical study titled "Mechanisms Underlying Efficacy of Prolonged Exposure". The primary objective of this research is to collect pilot data that demonstrates that proposed neural, psychophysiological and subjective markers measured before, during, and after treatment change over the course of Prolonged Exposure therapy (PE) for posttraumatic stress disorder (PTSD). The aims...
What is the current status of trial NCT05788302?
This trial is currently recruiting. It is a NA study. The enrollment target is 50 participants. The study started on 2023-04-01. Estimated completion is 2027-12-01.
What conditions does trial NCT05788302 study?
This clinical trial studies the following conditions: Post Traumatic Stress Disorder.
What interventions are being tested in trial NCT05788302?
The interventions under investigation include: Prolonged Exposure (BEHAVIORAL).
Who is sponsoring clinical trial NCT05788302?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05788302 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 NCT05788302's enrollment target sits among peer trials
50 176th of 262 higher than 83 of 262 other Post Traumatic Stress Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Post Traumatic Stress Disorder 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.
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