CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 74 enrolled
Drug / intervention
Psychoeducation +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04617769
NCT04617769N/ACompleted

Effects of Antagonistic Actions in Response to Trauma Exposure

University of Texas at Austin·interventional·Posted Nov 5, 2020·Updated Jan 11, 2024

In Brief

A clinical study evaluating Psychoeducation and Exposure for Post Traumatic Stress Disorder. Completed, enrolled 74 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedNov 5, 2020
Enrollment StartMar 22, 2021
Primary CompletionMay 15, 2023
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 5.7 years ago

Interventions

Psychoeducationbehavioral

psychoeducational materials on trauma and safety behaviors

Exposurebehavioral

six 3-minute video exposure trials with an inter-trial interval of 2 minutes