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NCT05149534 · ClinicalTrials.gov registry record · NA
rTMS-augmented Written Exposure Therapy for PTSD
A NA study of Post Traumatic Stress Disorder, sponsored by VA Office of Research and Development.
- Recruiting
- Registry status
- NA
- Development phase
- 98
- Enrollment target
- 1
- Study location
NCT05149534: Recruiting NA study of Post Traumatic Stress Disorder, sponsored by VA Office of Research and Development.
NCT05149534 is a NA study of Post Traumatic Stress Disorder that is actively recruiting participants, run by VA Office of Research and Development. The registered enrollment target is 98 participants, below the 663-participant average among 262 other Post Traumatic Stress Disorder trials with a reported enrollment target (85% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05149534, a NA study of Post Traumatic Stress Disorder, is actively recruiting participants, sponsored by VA Office of Research and Development.
- RECRUITING
- Registry status
- NA
- Development phase
- 98 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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 (abs
Conditions Studied
Interventions
- BEHAVIORAL Written Exposure Therapy
- DEVICE repetitive transcranial magnetic stimulation
Study Locations (1)
Texas
- Central Texas Veterans Health Care System, Temple, TX - Temple
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 98 participants |
| Start Date | 2022-01-03 |
| Est. Completion | 2027-01-29 |
| Phase | NA |
What NCT05149534 shows while recruiting
NCT05149534 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 98 participants, a relatively small participant target, below the 663-participant average among 262 other Post Traumatic Stress Disorder trials with a reported enrollment target (85% lower).
The record links to 1 condition, with Post Traumatic Stress Disorder appearing as the primary indexed condition, and to 2 interventions - of which Written Exposure Therapy is the first listed.
NCT05149534 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT05149534 about?
NCT05149534 is a clinical study titled "rTMS-augmented Written Exposure Therapy for 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...
What is the current status of trial NCT05149534?
This trial is currently recruiting. It is a NA study. The enrollment target is 98 participants. The study started on 2022-01-03. Estimated completion is 2027-01-29.
What conditions does trial NCT05149534 study?
This clinical trial studies the following conditions: Post Traumatic Stress Disorder.
What interventions are being tested in trial NCT05149534?
The interventions under investigation include: Written Exposure Therapy (BEHAVIORAL), repetitive transcranial magnetic stimulation (DEVICE).
Who is sponsoring clinical trial NCT05149534?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05149534 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05149534's enrollment target sits among peer trials
98 115th of 262 higher than 148 of 262 other Post Traumatic Stress Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Post Traumatic Stress Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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