Home › Post-Traumatic Stress Disorder › NCT05788302

Mechanisms Underlying Efficacy of Prolonged Exposure

Who can join

Ages 18 and older · All sexes

Inclusion Criteria:

1. Age 18 or older
2. 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), and
3. Interest in starting PE

Exclusion Criteria:

1. Current or past history of schizophrenic or other psychotic disorders,
2. Untreated Bipolar Disorder or a history of a manic/mixed episode within the last 6 months,
3. Severe traumatic brain injury,
4. Major neurological problems,
5. Current substance use disorder of moderate or greater severity assessed by the DIAMOND,
6. Active risk to self or others,
7. Current participation in therapy other than present-centered supportive therapy,
8. Previously received \> 2 sessions of Prolonged Exposure, and
9. Having no memory of their traumatic event.
10. For participants who are currently prescribed psychotropic medication, they will be eligible for the study provided medication use has been stable for 2 months prior to enrollment and remains stable throughout participation

About the study

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.

What is being tested

• Prolonged Exposure (behavioral)

Sponsor: Massachusetts General Hospital · Participants: 50 · Started: Apr 1, 2023

Contact the study team

• Amanda W Baker, Ph.D. · Phone: 617-643-6703
• Vladimir Ivkovic, Ph.D. · Phone: 617-724-5550

Official record on ClinicalTrials.gov — NCT05788302

Locations in the U.S.

Conditions

• Post-Traumatic Stress Disorder

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.