RECRUITING

Improving Therapeutic Learning for PTSD

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Conditions

PTSDPost Traumatic Stress Disorder

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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 proposed project seeks to demonstrate the engagement of post-exposure dopamine neurotransmission and downstream acute reorganization of dopaminergic resting-state neural networks as a means of increasing consolidation of extinction memories formed during analogue exposure therapy in adult women with PTSD. Participants will include 120 women aged 21-50 with a current diagnosis of PTSD related to physical or sexual assault, English speaking, and medically healthy. Participants will complete the stages of the study across 2-3 days, depending on participant need.

Official Title

Improving Therapeutic Learning for PTSD

Quick Facts

Study Start:2021-02-18
Study Completion:2023-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04558112

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:21 Years to 50 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Current diagnosis of PTSD where the index traumatic event includes physical or sexual assault
  2. * English speaking
  3. * Medically healthy
  1. * internal ferromagnetic objects (such as electronic devices, surgical implants, shrapnel, etc.)
  2. * major medical disorders (such as cancer)
  3. * psychotic disorders
  4. * neurocognitive disorders
  5. * developmental disorders
  6. * pregnancy
  7. * breastfeeding
  8. * use of Monoamine oxidase inhibitors (MAO-I) in past two weeks is exclusionary
  9. * heart disease
  10. * hepatic impairment
  11. * peptic ulcer disease
  12. * COPD
  13. * prescription medications that may interact with L-DOPA will not be permitted during a predetermined wash-out period
  14. * Claustrophobia, or the inability to lie still in a confined space
  15. * Major medical disorders (e.g., HIV, cancer)
  16. * Magnetic metallic implants (such as screws, pins, shrapnel remnants, aneurysm clips, artificial heart valves, inner ear (cochlear) implants, artificial joints, and vascular stents), as these may heat, pull, or twist in the strong magnetic field of the MRI scanner
  17. * Electronic or magnetic implants, such as pacemakers, as these may stop working
  18. * Permanent makeup or tattoos with metallic dyes
  19. * A positive pregnancy test (for females), since the effect of strong magnetic fields and L-Dopa on the developing fetus remains unknown and inconclusive. (all female participants of childbearing potential will have a pregnancy test on the day of the MRI scan. Participants who test positive would be notified of this positive result)
  20. * A self-reported history of loss of consciousness (greater than 30 minutes)
  21. * Physical disabilities that prohibit task performance (such as blindness or deafness)
  22. * Psychotic disorders (e.g., schizophrenia)
  23. * Any other condition that the investigator believes might put the participant at risk
  24. * Medications which may affect image quality (e.g., water pills)
  25. * Nonremovable dental implants, such as braces or upper permanent retainers, as these will distort the MRI images we collect (note: filings, crowns, and silver or gold teeth are OK)
  26. * Any other condition, medication, or implant that the investigator believes would degrade image quality or render data unusable

Contacts and Locations

Study Contact

Rachel Williams
CONTACT
608-262-6375
rmwilliams5@wisc.edu

Principal Investigator

Zachary Stowe, MD
PRINCIPAL_INVESTIGATOR
University of Wisconsin, Madison

Study Locations (Sites)

University of Texas
Austin, Texas, 78701
United States
University of Wisconsin
Madison, Wisconsin, 53593
United States

Collaborators and Investigators

Sponsor: University of Wisconsin, Madison

  • Zachary Stowe, MD, PRINCIPAL_INVESTIGATOR, University of Wisconsin, Madison

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 Date2021-02-18
Study Completion Date2023-12

Study Record Updates

Study Start Date2021-02-18
Study Completion Date2023-12

Terms related to this study

Additional Relevant MeSH Terms

  • PTSD
  • Post Traumatic Stress Disorder