NCT05149534 · VA Office of Research and Development
rTMS-augmented Written Exposure Therapy for PTSD
What this study is about
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.
View original scientific 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- -All veterans are eligible to be included in the study if they meet all the following criteria:
- 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.
Where
- Temple, Texas
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 12, 2026 · Source of record for eligibility and locations