Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05788302

Mechanisms Underlying Efficacy of Prolonged Exposure

Led by Massachusetts General Hospital · Updated on 2025-11-13

50

Participants Needed

1

Research Sites

243 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Mechanisms Underlying Efficacy of Prolonged Exposure

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 or older
  • Meeting diagnostic criteria for PTSD as defined by DSM-5 assessed by the Diagnostic Interview for Anxiety, Mood, and Obsessive-compulsive and related Psychiatric Disorders (DIAMOND)
  • Interest in starting Prolonged Exposure therapy
Not Eligible

You will not qualify if you...

  • Current or past history of schizophrenic or other psychotic disorders
  • Untreated Bipolar Disorder or a history of a manic/mixed episode within the last 6 months
  • Severe traumatic brain injury
  • Major neurological problems
  • Current substance use disorder of moderate or greater severity assessed by the DIAMOND
  • Active risk to self or others
  • Current participation in therapy other than present-centered supportive therapy
  • Previously received more than 2 sessions of Prolonged Exposure therapy
  • Having no memory of their traumatic event
  • For participants on psychotropic medication, medication use must have been stable for 2 months prior to enrollment and remain stable throughout participation

AI-Screening

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Trial Site Locations

Total: 1 location

1

MGH

Boston, Massachusetts, United States, 02114

Actively Recruiting

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Research Team

A

Amanda W Baker, Ph.D.

CONTACT

V

Vladimir Ivkovic, Ph.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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