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rTMS-augmented Written Exposure Therapy for PTSD

N/A
Recruiting
Led By Crystal M Lantrip
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Between the ages of 18 and 50 years
Diagnosed with PTSD
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre intervention (baseline), post-intervention (treatment session 5), and following the conclusion of the intervention, up to 3 months
Awards & highlights

Study Summary

This trial will test whether adding a brain-based therapy, repetitive transcranial magnetic stimulation (rTMS), to an evidence-based psychotherapy (EBP), written exposure therapy (WET), results in improved PTSD outcomes for Veterans. The investigators will also determine if emotional flexibility is a mechanism of symptom improvement.

Who is the study for?
This trial is for English-speaking veterans aged 18-50 with PTSD, who are right-handed and can consent in writing. It's not for those over 50, pregnant women, individuals with seizure history or serious neurological issues, current substance abusers, people at risk of suicide, or those with cognitive impairments.Check my eligibility
What is being tested?
The study tests if adding rTMS (a non-invasive brain stimulation technique) to Written Exposure Therapy (WET), a brief psychotherapy treatment for PTSD, improves outcomes compared to WET with sham rTMS. The focus is on enhancing emotional flexibility as a key mechanism.See study design
What are the potential side effects?
rTMS may cause discomfort at the stimulation site, headache or lightheadedness. Rarely it could induce seizures. There are no significant side effects expected from Written Exposure Therapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 50 years old.
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I have been diagnosed with PTSD.
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I speak English and can sign a consent form.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre intervention (baseline), post-intervention (treatment session 5), and following the conclusion of the intervention, up to 3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre intervention (baseline), post-intervention (treatment session 5), and following the conclusion of the intervention, up to 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Clinician Administered PTSD Scale for DSM-5 (CAPS-5)
Secondary outcome measures
Change in PTSD Symptom Checklist for DSM-5 (PCL-5)

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active TMS/WETExperimental Treatment2 Interventions
Active repetitive transcranial magnetic stimulation completed prior to written exposure therapy
Group II: Sham TMS/WETPlacebo Group2 Interventions
Sham repetitive transcranial magnetic stimulation completed prior to written exposure therapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Written Exposure Therapy
2021
Completed Phase 2
~370
repetitive transcranial magnetic stimulation
2014
N/A
~470

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,609 Previous Clinical Trials
3,306,331 Total Patients Enrolled
National Center for PTSDFED
12 Previous Clinical Trials
973 Total Patients Enrolled
Crystal M LantripPrincipal InvestigatorCentral Texas Veterans Health Care System, Temple, TX

Media Library

Written Exposure Therapy (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05149534 — N/A
Post-Traumatic Stress Disorder Research Study Groups: Active TMS/WET, Sham TMS/WET
Post-Traumatic Stress Disorder Clinical Trial 2023: Written Exposure Therapy Highlights & Side Effects. Trial Name: NCT05149534 — N/A
Written Exposure Therapy (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05149534 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it possible for me to join this clinical experiment?

"For this medical trial to be successful, 98 individuals must meet the criteria of having PTSD and being between 18-50 years old."

Answered by AI

Are any participants currently being enrolled in this experimentation?

"According to the clinicaltrials.gov website, recruitment for this medical trial is proceeding as planned since its original posting on March 1st 2022 and latest update December 1st of the same year."

Answered by AI

Does the age requirement for this research extend past four decades?

"This clinical trial is open to individuals between the ages of 18 and 50. In contrast, there are 46 studies for people under eighteen years old and 328 trials available to those over 65."

Answered by AI

What is the uppermost limit of individuals participating in this clinical trial?

"Affirmative. According to clinicaltrials.gov, this medical trial has been recruiting since it was first published on March 1st 2022 and is still ongoing, with the most recent update happening December 1st 2022. This research requires 98 patients from a single centre of care."

Answered by AI

Who else is applying?

What state do they live in?
Texas
How old are they?
18 - 65
What site did they apply to?
Central Texas Veterans Health Care System, Temple, TX
What portion of applicants met pre-screening criteria?
Met criteria

How responsive is this trial?

Most responsive sites:
  1. Central Texas Veterans Health Care System, Temple, TX: < 48 hours
Average response time
  • < 2 Days
Typically responds via
Email
Recent research and studies
clinicaltrials.govStudy
rTMS-augmented Written Exposure Therapy for PTSD
2022. "rTMS-augmented Written Exposure Therapy for PTSD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05149534.
All > Ptsd Austin
~54 spots leftby Jan 2027
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