NCT04617769

Effects of Antagonistic Actions in Response to Trauma Exposure

Completed NA Last updated 11 January 2024

What this trial tests

NA trial testing Psychoeducation in Post Traumatic Stress Disorder in 74 participants. Completed in 15 May 2023.

Timeline

22 March 2021

Primary endpoint
15 May 2023

15 May 2023

Quick facts

Lead sponsor	University of Texas at Austin
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	double
Primary purpose	treatment
Enrollment	74
Start date	22 March 2021
Primary completion	15 May 2023
Estimated completion	15 May 2023
Sites	1 location across United States

Drugs / interventions tested

• Psychoeducation
• Exposure

Conditions studied

• Post Traumatic Stress Disorder — all drugs for Post Traumatic Stress Disorder →

Sponsor

University of Texas at Austin

Who can join

Adults 18 to 60, any sex, with Post Traumatic Stress Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.