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NCT01391832 · ClinicalTrials.gov registry record · NA
Novel Treatment of Emotional Dysfunction in Post Traumatic Stress Disorder (PTSD)
A NA study, sponsored by The University of Texas at Dallas.
- Completed
- Registry status
- NA
- Development phase
- 103
- Enrollment target
NCT01391832: Completed NA study, sponsored by The University of Texas at Dallas.
NCT01391832 is a NA study that has completed, run by The University of Texas at Dallas. The registered enrollment target is 103 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01391832, a NA study, has completed, sponsored by The University of Texas at Dallas.
- COMPLETED
- Registry status
- NA
- Development phase
- 103 participants
- Enrollment target
Study Summary
The objective will be to determine if adding repetitive transcranial magnetic stimulation prior to Cognitive Processing Therapy significantly enhances recovery from hyperarousal symptoms in individuals with combat related post traumatic stress disorder and improves clinical outcome. The investigators have assembled a multimodal human performance laboratory including 64 channel EEG and repetitive transcranial magnetic stimulation system. These resources combined with the neuroimaging capabilities of the Advanced Imaging Research Center (AIRC) at UT Southwestern and skilled Cognitive Processing Therapy (CPT) practitioners will be used in this study. The study involves approximately 19 visits. Treatment is once a week for 12 weeks followed by a 1 month, 3 month and 6 month follow-up appointments.
Primary Outcome
The primary outcome measure of treatment efficacy for post-traumatic stress disorder (PTSD) will be change in the Clinician Administered Post-Traumatic Stress Disorder Scale (CAPS) Total Severity Score (i.e., summed across frequency and intensity ratings for the 17 PTSD assessment items) from baseline at 1-month post-treatment. CAPS Total Severity Score ranges from 0 to 136. Difference scores were calculated as the outcome score minus the baseline score, with negative scores indicating a reducti
Interventions
- DEVICE Repetitive Transcranial Magnetic Stimulation (rTMS)
- BEHAVIORAL Cognitive Processing Therapy
- DEVICE Repetitive Transcranial Magnet Stimulation (rTMS)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 103 participants |
| Start Date | 2011-07 |
| Est. Completion | 2016-02 |
| Phase | NA |
What the finished NCT01391832 record still lists
NCT01391832 is an interventional study that assigns participants to a tested intervention. The registered 103 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 3 interventions - of which Repetitive Transcranial Magnetic Stimulation (rTMS) is the first listed.
NCT01391832 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01391832 about?
NCT01391832 is a clinical study titled "Novel Treatment of Emotional Dysfunction in Post Traumatic Stress Disorder (PTSD)". The objective will be to determine if adding repetitive transcranial magnetic stimulation prior to Cognitive Processing Therapy significantly enhances recovery from hyperarousal symptoms in individuals with combat related post traumatic stress disorder and improves clinical outcome. The investigato...
What is the current status of trial NCT01391832?
This trial is currently completed. It is a NA study. The enrollment target is 103 participants. The study started on 2011-07. Estimated completion is 2016-02.
What interventions are being tested in trial NCT01391832?
The interventions under investigation include: Repetitive Transcranial Magnetic Stimulation (rTMS) (DEVICE), Cognitive Processing Therapy (BEHAVIORAL), Repetitive Transcranial Magnet Stimulation (rTMS) (DEVICE).
Who is sponsoring clinical trial NCT01391832?
This trial is sponsored by The University of Texas at Dallas, which has 50 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01391832's enrollment target sits among peer trials
103 837th of 2000 higher than 1,164 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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