RECRUITING

Mechanisms Underlying the Efficacy of Prolonged Exposure

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Mechanisms Underlying the Efficacy of Prolonged Exposure

Quick Facts

Study Start:2024-01-01
Study Completion:2027-01-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05663151

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 90 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. a diagnosis of PTSD as defined by DSM-5 (as indicated by meeting diagnostic criteria on the CAPS-5)
  2. 2. interest in starting PE (as indicated during the informed consent process)
  3. 3. Veteran
  1. 1. Current or past history of schizophrenic or other psychotic disorders,
  2. 2. Untreated Bipolar Disorder or a history of a manic/mixed episode within the last 6 months,
  3. 3. Severe traumatic brain injury,
  4. 4. Major neurological problems,
  5. 5. Current substance use disorder,
  6. 6. Active risk to self or others,
  7. 7. Current participation in cognitive-behavioral therapy,
  8. 8. Previously received \> 2 sessions of Prolonged Exposure, and
  9. 9. Having no memory of their traumatic event.
  10. 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

Contacts and Locations

Study Contact

Suzanne Pineles, PhD
CONTACT
857-364-5906
suzanne.pineles@va.gov
Vladimir Ivkovic, Phd
CONTACT
vladimir.ivkovic@va.gov

Principal Investigator

Suzanne Pineles
PRINCIPAL_INVESTIGATOR
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Study Locations (Sites)

VA Boston Healthcare System
Boston, Massachusetts, 02116
United States

Collaborators and Investigators

Sponsor: VA Boston Healthcare System

  • Suzanne Pineles, PRINCIPAL_INVESTIGATOR, VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-01
Study Completion Date2027-01-01

Study Record Updates

Study Start Date2024-01-01
Study Completion Date2027-01-01

Terms related to this study

Keywords Provided by Researchers

  • Prolonged Exposure Therapy
  • PTSD
  • Sleep

Additional Relevant MeSH Terms

  • Posttraumatic Stress Disorder