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NCT04617769 · ClinicalTrials.gov registry record · NA

Effects of Antagonistic Actions in Response to Trauma Exposure

A NA study, sponsored by University of Texas at Austin.

Completed
Registry status
NA
Development phase
74
Enrollment target

NCT04617769 is a NA study that has completed, run by University of Texas at Austin. The registered enrollment target is 74 participants.

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The verdict

NCT04617769, a NA study, has completed, sponsored by University of Texas at Austin.

COMPLETED
Registry status
NA
Development phase
74 participants
Enrollment target

Study Summary

The overarching objective of this study is to investigate the use of antagonistic actions as a treatment augmentation strategy for enhancing emotional processing during exposure to trauma-relevant stimuli. To accomplish this, participants (N = 84) reporting exposure to a combat, sexual assault, physical assault, or motor vehicle accident Criterion A trauma will be randomized to one of three experimental conditions: (a) Psychoeducation alone (PSYED); (b) Psychoeducation followed by repeated exposure to trauma-videoclips (PSYED + EXP); or (c) Psychoeducation followed by repeated exposure to trauma-videoclips while engaging in antagonistic actions (PSYED + EXP + AA). Antagonistic action strategies during exposure to the trauma-videoclips will include (a) adopting an open posture; (b) eating a palatable snack; (c) smiling; and (d) wishing on high levels of emotional distress. The investigators expect that (a) those randomized to receive psychoeducation alone will show less improvement relative to the two groups that receive psychoeducation plus repeated exposure to trauma-videoclips; (b) those receiving psychoeducation in combination with repeated exposure to trauma-videoclips while performing antagonistic actions will show significantly enhanced treatment outcome at the one-month follow-up relative to the other two treatment arms; (c) participants with greater PTSD symptom severity are likely to have a poorer treatment outcome to PSYED alone; (d) changes in trauma-related threat appraisals, coping self-efficacy, and safety behaviors will each independently mediate the effects of treatment; and (e) participants displaying reductions in their emotional reactivity are more likely to have a reduction in PTSD symptoms.

Interventions

  • BEHAVIORAL Psychoeducation
  • BEHAVIORAL Exposure

Trial Details

FieldValue
Enrollment Target 74 participants
Start Date 2021-03-22
Est. Completion 2023-05-15
Phase NA

Sponsor

University of Texas at Austin

257 total trials

What the Registry Record Tells You About NCT04617769

The ClinicalTrials.gov registry entry for NCT04617769 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 74 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Texas at Austin, which has 257 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Psychoeducation is the first listed.

NCT04617769 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT04617769 about?

NCT04617769 is a clinical study titled "Effects of Antagonistic Actions in Response to Trauma Exposure". The overarching objective of this study is to investigate the use of antagonistic actions as a treatment augmentation strategy for enhancing emotional processing during exposure to trauma-relevant stimuli. To accomplish this, participants (N = 84) reporting exposure to a combat, sexual assault, phys...

What is the current status of trial NCT04617769?

This trial is currently completed. It is a NA study. The enrollment target is 74 participants. The study started on 2021-03-22. Estimated completion is 2023-05-15.

What interventions are being tested in trial NCT04617769?

The interventions under investigation include: Psychoeducation (BEHAVIORAL), Exposure (BEHAVIORAL).

Who is sponsoring clinical trial NCT04617769?

This trial is sponsored by University of Texas at Austin, which has 257 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.