How prolonged exposure therapy helps people with PTSD.

Mechanisms Underlying Efficacy of Prolonged Exposure

This project will see if brain activity, bodily responses, and symptom reports change across 10 sessions of Prolonged Exposure and predict improvement in adults with PTSD.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Massachusetts General Hospital (Academic / other)
• Locations: 1 site (Boston, Massachusetts)
• Trial ID: NCT05788302 on ClinicalTrials.gov

What this trial studies

Up to 50 people will be screened with the goal of 15 participants completing a standard 10-session Prolonged Exposure (PE) program; participants must meet DSM-5 criteria for PTSD and be interested in starting PE. During each 60-minute PE session participants will wear a NINscan device to record skin conductance, heart rate, facial EMG, and lateral prefrontal cortex (LPFC) activity, and will complete multimodal assessment batteries at pre-treatment, mid-treatment (after session 5), post-treatment (after session 10), and one-month follow-up. The primary outcome is change in PTSD symptoms on the CAPS-5; secondary outcomes include self-reported symptom change, premature treatment dropout, and changes in psychophysiological and LPFC measures during script-driven imagery. The project aims to identify pretreatment predictors and mechanistic markers that change with PE to inform personalization and theoretical models of exposure therapy.

Who should consider this trial

Good fit: Adults aged 18 or older who meet DSM-5 criteria for PTSD, are interested in starting Prolonged Exposure, and are medically and psychiatrically stable (including stable psychotropic medication for at least two months) are the intended participants.

Not a fit: Individuals with current or past psychotic disorders, recent bipolar manic/mixed episodes, severe traumatic brain injury or major neurological problems, active moderate-or-greater substance use disorder, active safety risk, absence of memory for the traumatic event, or who have already received more than two PE sessions are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, the results could help clinicians predict who will benefit from PE and tailor exposure therapy to improve patient outcomes.

How similar studies have performed: Prior studies have found links between physiological or neural markers and PTSD treatment response, but longitudinal, session-level multimodal recording during PE is relatively novel and remains pilot in nature.

Eligibility criteria

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

Where this trial is running

Boston, Massachusetts

• Mgh — Boston, Massachusetts, United States (Recruiting)

Study contacts

• Principal investigator: Amanda W Baker, Ph.D. — Massachusetts General Hospital
• Study coordinator: Amanda W Baker, Ph.D.

Conditions Post Traumatic Stress Disorder; Exposure Therapy