Mechanisms Underlying Efficacy of Prolonged Exposure

Recruiting now · Not applicable

Conditions studied: Post Traumatic Stress Disorder

In brief

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.

Key facts

Study ID

NCT05788302

Run by

Massachusetts General Hospital

People needed

50

Starts

2023-04-01

Expected to finish

2027-12-01

Last updated by the study team

2025-11-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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), and
• Interest in starting PE

You may not qualify if…

• 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 > 2 sessions of Prolonged Exposure, and
• Having no memory of their traumatic event.
• 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

Where it is running

• MGH — Boston, Massachusetts, United States (enrolling)

Full record on ClinicalTrials.gov

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