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NCT02573246 · ClinicalTrials.gov registry record · NA
Neuromodulation Enhanced Cognitive Restructuring: A Proof of Concept Study
A NA study, sponsored by Duke University.
- Completed
- Registry status
- NA
- Development phase
- 148
- Enrollment target
NCT02573246 is a NA study that has completed, run by Duke University. The registered enrollment target is 148 participants.
The verdict
NCT02573246, a NA study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- NA
- Development phase
- 148 participants
- Enrollment target
Study Summary
Psychological treatments are effective, but take a long time and can be burdensome. Therefore, avenues to optimize behavioral treatments are needed. Despite important advancements, neuroscience has had a limited effect on psychotherapy development. Therefore, one paradigm shift would be to develop neuroscience informed behavioral treatments. The investigators identified from the literature a problem that affects several mental disorders (emotion dysregulation) and a neural circuit that underlies this important concern. They found that this circuit is dysfunctional in those with psychopathology but can be changed with treatment. The goal is in one session to train this brain network to operate more efficiently and to test the short and long term effects of this intervention. The investigators plan to engage this brain network using a traditional psychotherapy strategy (cognitive restructuring) and to enhance learning using repetitive transcranial magnetic stimulation (rTMS), a neuromodulation technique through which magnetic stimulation enhances the electrical activity in brain areas close to the scalp. The study team proposed two studies to examine this novel approach, In one of the studies 83 participants were enrolled and 47 eligible participants were divided into 3 groups. All participants were trained in emotion regulation by first being asked to remember an event where they experienced a negative emotion and then being instructed either to think differently about the event, or to wait. Participants simultaneously underwent either active (left or right side of brain) or sham rTMS. In a second study 65 participants were enrolled, and 31 were assigned to either active left or sham rTMS guided using neuroimaging results. Across both studies, the investigators measured regulation in the lab and during a-week long naturalistic assessment. Participants in the second study returned for a follow up neuroimaging visit at the end of this week. Participants returned for
Interventions
- BEHAVIORAL Cognitive Restructuring
- DEVICE Sham rTMS
- DEVICE rTMS
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 148 participants |
| Start Date | 2016-03 |
| Est. Completion | 2020-02-17 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02573246
The ClinicalTrials.gov registry entry for NCT02573246 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 148 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Cognitive Restructuring is the first listed.
NCT02573246 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02573246 about?
NCT02573246 is a clinical study titled "Neuromodulation Enhanced Cognitive Restructuring: A Proof of Concept Study". Psychological treatments are effective, but take a long time and can be burdensome. Therefore, avenues to optimize behavioral treatments are needed. Despite important advancements, neuroscience has had a limited effect on psychotherapy development. Therefore, one paradigm shift would be to develop n...
What is the current status of trial NCT02573246?
This trial is currently completed. It is a NA study. The enrollment target is 148 participants. The study started on 2016-03. Estimated completion is 2020-02-17.
What interventions are being tested in trial NCT02573246?
The interventions under investigation include: Cognitive Restructuring (BEHAVIORAL), Sham rTMS (DEVICE), rTMS (DEVICE).
Who is sponsoring clinical trial NCT02573246?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
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