Mechanisms Underlying the Efficacy of Prolonged Exposure

NCT05663151 | Recruiting

• 1 other identifier: 1577670
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Posttraumatic Stress Disorder

Keywords

Prolonged Exposure Therapy; PTSD; Sleep

Outcome Measures

Primary Outcomes (1)

• Change from baseline in Clinician Administered PTSD Scale for DSM-5 (CAPS-5)

  The primary clinical outcome, CAPS-5, is the gold standard clinical interview for assessing PTSD severity. In CAPS-5, each of the 20 symptoms of PTSD is rated on a 5-point severity scale ranging from 0 (absent) to 4 (extreme). Total scores range from 0 to 80.

  Given during screening session, pre-treatment, mid-treatment (post session 5 in week 5 of treatment), post-treatment (post session 10 in week 10 of treatment), and at 1-month follow up.

Secondary Outcomes (8)

• PTSD Checklist for DSM-5 (PCL-5)

  Given during screening session, pre-treatment, mid-treatment (post session 5 in week 5 of treatment), post-treatment (post session 10 in week 10 of treatment), and at 1-month follow up.

• QIDS-SR (93)

  Given during screening session, pre-treatment, mid-treatment (post session 5 in week 5 of treatment), post-treatment (post session 10 in week 10 of treatment), and at 1-month follow up.

• Prefrontal cortical activity during script-driven imagery (SDI)

  Given during screening session, pre-treatment, mid-treatment (post session 5 in week 5 of treatment), post-treatment (post session 10 in week 10 of treatment), and at 1-month follow up.

• Change in electrocardiography (ECG) and heart rate variability (HRV) during script driven imagery (SDI)

  Given during screening session, pre-treatment, mid-treatment (post session 5 in week 5 of treatment), post-treatment (post session 10 in week 10 of treatment), and at 1-month follow up.

• Change in skin conductance (SC) during script-driven imagery (SDI)

  Given during screening session, pre-treatment, mid-treatment (post session 5 in week 5 of treatment), post-treatment (post session 10 in week 10 of treatment), and at 1-month follow up.

Study Arms (1)

Prolonged Exposure Therapy for Posttraumatic Stress Disorder

EXPERIMENTAL

15 participants who meet study inclusion/exclusion criteria will be individually administered a full course of PE during 10, 60 minute-sessions, with independent multimodal assessment batteries administered at pre-treatment, mid-treatment (post session 5), post-treatment, and a 1-month follow-up.

Behavioral: Prolonged Exposure Therapy for Posttraumatic Stress Disorder

Interventions

Prolonged Exposure Therapy for Posttraumatic Stress Disorder BEHAVIORAL

Participation will occur throughout 17 weeks over 15 separate visits during which 10, 60-minute sessions of PE will take place. Session 1 of PE will focus on psychoeducation. Session 2 of PE will involve a continuation of psychoeducation and rationale for exposure as well as the collaborative construction of the in vivo exposure hierarchy. After session 2, participants will begin homework where they are instructed to confront situations on their hierarchy. Starting in session 3 of PE, participants will begin imaginal exposures to their worst trauma memory. This involves the participant recounting and visualizing the trauma memory aloud with the clinician in the room for 30-40 minutes. The session will end with 15-20 minutes of processing the imaginal exposure. Participants will continue in-session imaginal exposures until the end of treatment. Throughout the treatment, participants will listen to a recording of their imaginal exposure and engage in in vivo exposures daily.

Prolonged Exposure Therapy for Posttraumatic Stress Disorder

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• a diagnosis of PTSD as defined by DSM-5 (as indicated by meeting diagnostic criteria on the CAPS-5)
• interest in starting PE (as indicated during the informed consent process)
• Veteran

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,
• Active risk to self or others,
• Current participation in cognitive-behavioral 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

Sponsors & Collaborators

• VA Boston Healthcare System: lead
• National Center for PTSD: collaborator

Study Sites (1)

VA Boston Healthcare System

Boston, Massachusetts, 02116, United States

RECRUITING

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MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Suzanne Pineles

  VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Suzanne Pineles, PhD

CONTACT

857-364-5906; suzanne.pineles@va.gov

Vladimir Ivkovic, Phd

CONTACT

vladimir.ivkovic@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator/Study Chair

Study Record Dates

• First Submitted: November 22, 2022
• First Posted: December 23, 2022
• Study Start: January 1, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: April 8, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available within a year of submission after publications.

Locations

US (1)