Recruiting

rTMS-augmented WET

Sponsor:

VA Office of Research and Development

Code:

NCT05149534

Conditions

Post Traumatic Stress Disorder

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Interventions

Written Exposure Therapy

repetitive transcranial magnetic stimulation

Study Details

Brief summary:

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.

Conditions

Post Traumatic Stress Disorder

Study ID

NCT05149534

Start date

Jan 3, 2022

Status verified date

Jan, 2026

Completion date

Jan 29, 2027

Anticipated

Primary completion date

Jan 29, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Inclusion Criteria:

-All veterans are eligible to be included in the study if they meet all the following criteria:

  • veteran;
  • English-speaking and able to provide written informed consent;
  • diagnosed with PTSD;
  • between the ages of 18 and 60 years. Participants over age 60 will not be included, as aging is known to impact brain structure, and thus the potential accuracy of the rTMS target, independently of PTSD.

Exclusion Criteria:

  • 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.
  • The effects of rTMS are unknown on fetal development, therefore, women who are pregnant will be excluded.
  • Participants will also be screened and excluded if any of the following are met:

  • current psychosis including psychotic disorder,
  • bipolar disorder,
  • schizophrenia; or another severe cognitive or psychiatric disorder;
  • positive screen for current suicidal intent and plan \[with a score of 2 or 3 on BDI-2 item 9\];
  • current substance use disorder; or substance use in the last 12 hours before the rTMS session.
  • 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.
  • Participants with moderate or severe TBI will be excluded.
  • Participants with mild traumatic brain injury (mTBI) or concussion will be enrolled. This will enhance the ecological validity of the study.
  • 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.
  • 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.
  • 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.

Study Design

Enrollment

98 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Active TMS/WET

Active repetitive transcranial magnetic stimulation completed prior to written exposure therapy

sham comparator: Sham TMS/WET

Sham repetitive transcranial magnetic stimulation completed prior to written exposure therapy

Interventions

Written Exposure Therapy

Narrative written disclosure of trauma administered in an evidence-based protocol.

repetitive transcranial magnetic stimulation

Noninvasive magnetic neuromodulation device

Primary outcome measure

  • Change in Clinician Administered PTSD Scale for DSM-5 (CAPS-5) [ Time Frame: Pre intervention (Baseline), post-intervention (Treatment Session 5), and following the conclusion of the intervention, up to 3 months ]

Central Contacts and Locations

Central contacts

Crystal M Lantrip

(254) 297-5155crystal.lantrip@va.gov

Locations

Central Texas Veterans Health Care System, Temple, TX

Recruiting

Temple, Texas, United States, 76504-7451

Contacts

Joseph F Maher

254-743-1478Joseph.Maher@va.gov

David E Dostal, PhD MA BS

(254) 743-2464david.dostal@va.gov

Principal Investigator:

Crystal M Lantrip

More Information

Sponsor

VA Office of Research and Development

Last update posted

Jan 12, 2026

Last verified

Jan, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-01-12.