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Post Traumatic Stress DisorderNCT05149534

rTMS-augmented Written Exposure Therapy for PTSD

A study testing Written Exposure Therapy and repetitive transcranial magnetic stimulation in people with Post Traumatic Stress Disorder, run by VA Office of Research and Development at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Post Traumatic Stress Disorder
What is being tested?
Written Exposure Therapy and repetitive transcranial magnetic stimulation
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
98 participants
Where
1 siteUnited States
Study dates
3 Jan 2022to 29 Jan 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • -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.

Who cannot join

  • 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;
Show all 14Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Crystal M Lantrip contact

(254) 297-5155

crystal.lantrip@va.gov

United States1 site, 1 recruiting
  • Central Texas Veterans Health Care System, Temple, TX

    Temple, Texas, 76504-7451

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

    David E Dostal, PhD MA BS, (254) 743-2464 ext. 42464, david.dostal@va.gov

    Recruiting

Other trials in United States

About this study

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

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.

Read the detailed description

The overarching goal of this CDA-2 proposal is to use repetitive transcranial magnetic stimulation (rTMS) to augment effectiveness of written exposure therapy (WET), a narrative-based trauma exposure paradigm, in treating posttraumatic stress disorder (PTSD) and emotion dysregulation in Operations Enduring Freedom (OEF) and Iraqi Freedom (OIF) Veterans. As a clinical neuropsychologist with expertise in emotion regulation, Dr. Lantrip's long-term goal is to improve upon and develop effective interventions for trauma-related illness in Veterans by identifying and targeting behavioral and neural mechanisms.

OEF/OIF Veterans have experienced increased length and number of deployments, contributing to diagnosis of PTSD. rTMS is a brain-based therapy involving application of a repetitive, brief magnetic pulse to the scalp through an electromagnetic coil. rTMS applied to the dorsolateral prefrontal cortex (DLPFC) has efficacy in patients with treatment-resistant depression, and recent work has shown efficacy for treating PTSD. Standard rTMS treatments are stand-alone, though the unique properties of rTMS may make it more effective when added to a psychotherapy such as an evidence-based psychotherapy (EBP) for PTSD.

rTMS is theorized to act on the DLPFC node of the brain's cognitive control network (CCN) to improve emotion regulatory processes and facilitate reduction in affective symptoms. In support of this theory, studies have found that improvements in affective flexibility, upregulation of positive affect, and downregulation of attention to negative stimuli occur in task-based paradigms immediately following stimulation of the DLPFC with rTMS in a single-session. In addition, recent research has found that rTMS prior to cognitive processing therapy (CPT) in Veterans with PTSD is effective at improving PTSD outcomes compared to sham rTMS plus CPT, possibly through the regulatory mechanism of the CCN. Given these promising findings, further study into optimizing rTMS-augmented EBPs for PTSD is warranted.

There are limitations to both rTMS and first line EBPs for PTSD. One problem is high numbers of sessions needed for effective treatment (i.e. 20 sessions of rTMS and 12-18 sessions of EBPs) contributing to high attrition rates. A large multi-site study of VA patients in PTSD clinic found that just 2% of a sample of 1924 Veterans who had at least one session of EBP received an "adequate dose" of at least 8 sessions.12 A potential optimization for rTMS-augmented EBPs would be to reduce session number to improve retention. WET is a novel EBP for PTSD that is non-inferior to CPT in as few as 5 sessions. Using rTMS to augment WET in Veterans with PTSD is a crucial step in this line of inquiry.

This double-blind, Phase II randomized controlled trial will examine whether rTMS added to WET results in superior outcomes compared to sham rTMS added to WET (N=98 with women and men equally represented). The investigators will randomize 49 OEF/OIF Veterans with PTSD to undergo an active rTMS/WET treatment protocol versus 49 OEF/OIF Veterans given a sham rTMS/WET treatment.

Specific Aim 1: To compare PTSD outcomes of those who experience active rTMS/WET versus sham rTMS/WET. Hypothesis 1: Active rTMS added to WET will contribute to greater PTSD symptom reduction compared to sham rTMS added to WET in Veterans with PTSD.

Specific Aim 2a: If there is a treatment effect in Aim 1, determine if emotional flexibility mediates the rTMS/WET-PTSD relation. Aim 2b (exploratory): Determine if emotional flexibility has a unique mediating effect over cognitive flexibility. Hypothesis 2a: Significant reduction in PTSD symptoms will be partially mediated by emotional flexibility. Hypothesis 2b: Significant reduction in PTSD symptoms will be partially mediated by cognitive flexibility, but to a lesser extent than emotional flexibility.

This CDA-2 extends Dr. Lantrip's research integrating emotion regulation and neurostimulation to understand and improve upon treatment of PTSD in Veterans. The CDA-2 will provide her with specialized training in WET, a unique exposure-based therapy for the treatment of trauma, as well as clinical trials for PTSD, and neurostimulation. The mentoring team integrates expertise in the proposed areas of study and extensive experience mentoring early career investigators. Project findings will inform a future VA Merit proposal, which will focus on individual differences and mechanisms contributing to PTSD symptom improvement in TMS-augmented behavioral therapy. This study has the potential to inform and improve upon existing treatments for PTSD. Together, Dr. Lantrip's work aligns with VA's priorities, CR\&D's mission, and with the goal to provide the highest quality of care for Veterans.

Being tested
Written Exposure Therapy, repetitive transcranial magnetic stimulation
Keywords
PTSD, Emotion Regulation, Cognitive flexibility, Affective Flexibility, Veterans
Medical subject headings
Stress Disorders, Post-Traumatic, Emotional Regulation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Written Exposure TherapyBehavioural

    Also called WET

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

  • repetitive transcranial magnetic stimulationDevice

    Also called rTMS

    Noninvasive magnetic neuromodulation device

Study groups in NCT05149534
Study groupRoleWhat they receive
Active TMS/WETExperimentalActive repetitive transcranial magnetic stimulation completed prior to written exposure therapy
Receives: Behavioral: Written Exposure Therapy; Device: repetitive transcranial magnetic stimulation
Sham TMS/WETSham comparatorSham repetitive transcranial magnetic stimulation completed prior to written exposure therapy
Receives: Behavioral: Written Exposure Therapy; Device: repetitive transcranial magnetic stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Clinician Administered PTSD Scale for DSM-5 (CAPS-5)

    The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) is a 30-item structured interview designed to make both a current and lifetime diagnosis of PTSD and to assess PTSD symptom severity over the last week or month. The assessor combines information about frequency and intensity of an item into a single severity rating. CAPS-5 total symptom severity scores are calculated by summing the individual item scores for symptoms corresponding to a given DSM-5 cluster. Severity ratings are from 0 (absent) to 5 (extreme/incapacitating)

    Measured: Pre intervention (Baseline), post-intervention (Treatment Session 5), and following the conclusion of the intervention, up to 3 months

Secondary outcomes (1)
  1. Change in PTSD Symptom Checklist for DSM-5 (PCL-5)

    PTSD will be measured with the widely used 20-item Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5), which assesses severity of each DSM-5 PTSD symptom using a Likert-style ranging from 0 (not at all) to 4 (extreme). A total score of 31-33 is suggestive of a PTSD diagnosis. Change in PTSD symptom severity from pre-to post-intervention will be examined.

    Measured: Pre intervention (Baseline), post-intervention (Treatment Session 5), and following the conclusion of the intervention, up to 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Dec 2021
  2. Study start3 Jan 2022
  3. Primary completion29 Jan 2027 (estimated)
  4. Study completion29 Jan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Double blind, randomized clinical trial
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
98 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05149534
Sponsor's protocol ID
MHBP-007-20F
Other IDs
1IK2CX002101-01A2
Status last verified
Jan 2026
First submitted
24 Nov 2021
Last updated
12 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No: A Limited Dataset (LDS) will be created and shared pursuant to a Data Use Agreement (DUA) appropriately limiting use of the dataset and prohibiting the recipient from identifying or re-identifying (or taking steps to identify or re-identify) any individual whose data are included in the dataset.

Questions about this trial

What is this clinical trial studying?

A study testing Written Exposure Therapy and repetitive transcranial magnetic stimulation in people with Post Traumatic Stress Disorder, run by VA Office of Research and Development at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Crystal M Lantrip ((254) 297-5155, crystal.lantrip@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026.

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