NCT05663151 Mechanisms Underlying the Efficacy of Prolonged Exposure
| NCT ID | NCT05663151 |
| Status | Recruiting |
| Phase | — |
| Sponsor | VA Boston Healthcare System |
| Condition | Posttraumatic Stress Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2024-01-01 |
| Primary Completion | 2027-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2024-01-01 with a primary completion date of 2027-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 pre-treatment 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.
Eligibility Criteria
Inclusion Criteria: 1. a diagnosis of PTSD as defined by DSM-5 (as indicated by meeting diagnostic criteria on the CAPS-5) 2. interest in starting PE (as indicated during the informed consent process) 3. Veteran 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, 6. Active risk to self or others, 7. Current participation in cognitive-behavioral 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
Contact & Investigator
Suzanne Pineles
PRINCIPAL INVESTIGATOR
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Frequently Asked Questions
Who can join the NCT05663151 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying Posttraumatic Stress Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05663151 currently recruiting?
Yes, NCT05663151 is actively recruiting participants. Contact the research team at suzanne.pineles@va.gov for enrollment information.
Where is the NCT05663151 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT05663151 clinical trial?
NCT05663151 is sponsored by VA Boston Healthcare System. The principal investigator is Suzanne Pineles at VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA. The trial plans to enroll 50 participants.