RECRUITING

rTMS-augmented Written Exposure Therapy for PTSD

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Conditions

Post Traumatic Stress DisorderPTSDEmotion RegulationCognitive flexibilityAffective FlexibilityVeterans

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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

Post-traumatic stress disorder (PTSD) is prevalent and represents a high healthcare burden among Veterans. Repetitive transcranial magnetic stimulation (rTMS) is a brain-based therapy that may be effective for treating PTSD. The theorized mechanism of rTMS is enhancement of emotional flexibility via the dorsolateral prefrontal cortex node of the brain's cognitive control network. Given this mechanism of action, adding rTMS to an evidence-based psychotherapy (EBP) for PTSD may enhance treatment effects. Written exposure therapy (WET) is a brief EBP for PTSD found to reduce attrition compared to lengthier first line treatments. In this study, the investigators will determine if active rTMS added to WET compared with sham rTMS added to WET results in improved PTSD outcomes. The investigators will also determine if emotional flexibility is a mechanism of symptom improvement. This work will improve upon PTSD intervention and inform the mechanism of treatment effectiveness for Veterans suffering from PTSD.

Official Title

Repetitive Transcranial Magnetic Stimulation Augmented Written Exposure Therapy for Veterans With PTSD

Quick Facts

Study Start:2022-01-03
Study Completion:2027-01-29
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05149534

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 50 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * veteran;
  2. * English-speaking and able to provide written informed consent;
  3. * diagnosed with PTSD;
  4. * between the ages of 18 and 50 years. Participants over age 50 will not be included, as aging is known to impact brain structure, and thus the potential accuracy of the rTMS target, independently of PTSD.
  1. * Individuals with history of seizures or other serious neurological history including acquired, developmental or degenerative neurologic illness, identified through medical chart review, will be excluded due to potential lowered threshold for seizures during rTMS stimulation.
  2. * The effects of rTMS are unknown on fetal development, therefore, women who are pregnant will be excluded.
  3. * Participants will also be screened and excluded if any of the following are met:
  4. * current psychosis including psychotic disorder,
  5. * bipolar disorder,
  6. * schizophrenia; or another severe cognitive or psychiatric disorder;
  7. * positive screen for current suicidal intent and plan \[with a score of 2 or 3 on BDI-2 item 9\];
  8. * current substance use disorder; or substance use in the last 12 hours before the rTMS session.
  9. * The investigators note that PTSD is often comorbid with traumatic brain injury (TBI) in military veterans who were deployed to a war zone. The investigators will use the Department of Defense and Veterans Affairs consensus-based classification of TBI severity for classification of TBI.
  10. * Participants with moderate or severe TBI will be excluded.
  11. * Participants with mild traumatic brain injury (mTBI) or concussion will be enrolled. This will enhance the ecological validity of the study.
  12. * Participants with cognitive impairment as evidenced by a Montreal Cognitive Screen (MoCA) less than 23/30 or estimated baseline intellectual ability of a standard score of less than 80 on a word reading test will be excluded due to potential neurocognitive differences.
  13. * Participants on psychotropic medications will not be excluded, but participants will be required to be stable on their medication for at least four weeks prior to beginning the study and throughout the time of study.
  14. * Participants enrolled in long term, supportive psychotherapy (i.e. not an evidence-based psychotherapy (EBP)) may continue to be involved in their treatment throughout the study. However, participants involved in a concurrent EBPs will be excluded. Participants will be asked to disclose whether they chose to participate in an EBP during the course of the treatment or followup phases of the study.

Contacts and Locations

Study Contact

Crystal M Lantrip
CONTACT
(254) 297-5155
crystal.lantrip@va.gov

Principal Investigator

Crystal M Lantrip
PRINCIPAL_INVESTIGATOR
Central Texas Veterans Health Care System, Temple, TX

Study Locations (Sites)

Central Texas Veterans Health Care System, Temple, TX
Temple, Texas, 76504-7451
United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

  • Crystal M Lantrip, PRINCIPAL_INVESTIGATOR, Central Texas Veterans Health Care System, Temple, TX

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 Date2022-01-03
Study Completion Date2027-01-29

Study Record Updates

Study Start Date2022-01-03
Study Completion Date2027-01-29

Terms related to this study

Keywords Provided by Researchers

  • PTSD
  • Emotion Regulation
  • Cognitive flexibility
  • Affective Flexibility
  • Veterans

Additional Relevant MeSH Terms

  • Post Traumatic Stress Disorder