rTMS-augmented Written Exposure Therapy for PTSD

NCT05149534 | Recruiting DMC FDA Device

• 2 other identifiers: MHBP-007-20F1IK2CX002101-01A2
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (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)

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

Secondary Outcomes (1)

• Change in PTSD Symptom Checklist for DSM-5 (PCL-5)

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

Study Arms (2)

Active TMS/WET

EXPERIMENTAL

Active repetitive transcranial magnetic stimulation completed prior to written exposure therapy

Behavioral: Written Exposure Therapy; Device: repetitive transcranial magnetic stimulation

Sham TMS/WET

SHAM COMPARATOR

Sham repetitive transcranial magnetic stimulation completed prior to written exposure therapy

Behavioral: Written Exposure Therapy; Device: repetitive transcranial magnetic stimulation

Interventions

repetitive transcranial magnetic stimulation DEVICE

Noninvasive magnetic neuromodulation device

Also known as: rTMS

Active TMS/WET; Sham TMS/WET

Written Exposure Therapy BEHAVIORAL

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

Also known as: WET

Active TMS/WET; Sham TMS/WET

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• VA Office of Research and Development: lead
• National Center for PTSD: collaborator

Study Sites (1)

Central Texas Veterans Health Care System, Temple, TX

Temple, Texas, 76504-7451, United States

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Emotional Regulation

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Self-Control; Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Crystal M Lantrip

  Central Texas Veterans Health Care System, Temple, TX

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Crystal M Lantrip

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants deemed eligible after the baseline assessments will be randomized using a computerized block randomization with a 1:1 allocation ratio of active rTMS/WET and sham rTMS/WET conditions. The investigators will be utilizing permuted block design with randomized blocks of 4 and 2. This will be conducted by an independent study coordinator who will be uninvolved in the research beyond randomization and blinding with assistance from a data analyst in addition to statistics consultant.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Double blind, randomized clinical trial

Study Record Dates

• First Submitted: November 24, 2021
• First Posted: December 8, 2021
• Study Start: January 3, 2022
• Primary Completion (Estimated): January 29, 2027
• Study Completion (Estimated): January 29, 2027
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)