Clinical trial NCT04617769: Effects of Antagonistic Actions in Response to Trauma Exposure
Official title: Effects of Antagonistic Actions in Response to Trauma Exposure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Traumatic Stress Disorder
Keywords: post traumatic stress disorder
PTSD
psychoeducation
exposure
trauma
combat
sexual assault
physical assault
motor vehicle accident
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
First posted: 2020-11-05
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Over 70% of Americans are exposed to trauma during their lifetime and approximately 5.6% will meet diagnostic criteria for posttraumatic stress disorder. Posttraumatic stress disorder (PTSD) can significantly interfere with social functioning, work, and increase one's risk for other physical and mental health problems. Trauma-focused psychotherapies for PTSD have been shown to outperform more traditional supportive psychotherapy or pharmacotherapy and have become the first line of treatment for PTSD. However, the impact of trauma-focused therapy such as Prolonged Exposure (PE) is reduced, due to high rates of attrition ranging from 38.5% to 50%. Thus, there is a clear need to develop treatments for PTSD that are more palatable.

Preliminary evidence suggests that exposure-based treatment may be enhanced by having patients engage in antagonistic actions (e.g., smiling, laughing, adopting an open posture, wishing on threatening outcomes) during exposure to the feared target. Prior research found that these actions increased the efficacy of exposure therapy among a sample of 88 patients with acrophobia. Specifically, participants were instructed to stand at the railing and look over the edge while shaking their head to induce dizziness, standing at the edge without holding onto the railing, or walking towards the railing with their eyes closed and hands behind their back. Participants in the antagonistic action exposure group exhibited a significantly greater reduction in peak fear over the course of the study compared to all other groups (89% reduction versus 54%). Although promising, augmenting exposure therapy with antagonistic actions has yet to be tested for enhancing exposure therapy for PTSD. For the present study, antagonistic actions will include (a) adopting an open posture; (b) eating a palatable snack; (c) smiling; and (d) wishing on high levels of emotional distress (e.g., "come on distress hit me with your best shot").

There is a gap in the literature on antagonistic actions related specifically to trauma exposure. By better understanding mechanisms underlying reactions to a trauma video clip and trauma symptom development, the investigators can begin to reduce the debilitating effects of psychopathology following exposure to traumatic events in the future.

The study is a 3 x 3 mixed model experimental design with treatment Condition as a three-level between-subjects factor and assessment period (baseline vs posttreatment vs follow-up) as a three-level within subjects factor. Participants (N = 84) reporting exposure to a combat, sexual assault, physical assault, or motor vehicle accident Criterion A trauma will complete a battery of baseline trauma-related symptom measures followed by a trauma memory provocation involving watching a brief trauma-relevant videoclip, during which behavioral and subjective indices of emotional reactivity will be collected. Participants will be stratified based on their trauma symptom severity (PCL-5) and trauma type (LEC-5) and then randomized to one of three 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 (e.g., "come on distress hit me with your best shot").

Participants randomized to the two trauma videoclip exposure arms will receive six 3-minute video exposure trials with an inter-trial interval of 2 minutes, during which participants will complete ratings of (a) peak subjective distress during the trauma-videoclip; (b) anticipated subjective distress for the next trial; and (c) level of confidence for coping with their own trauma memory.

Eligibility criteria: Inclusion Criteria:

1. Age 18 to 60
2. Speaks English fluently
3. Identify either an assault, motor vehicle accident, or combat index trauma on the LEC-5
4. Access to the internet
5. Willingness to provide signed informed consent
6. Willingness to refrain from all non-study trauma-focused treatment during the study period

Exclusion Criteria:

1. History of a suicide attempt within the past 6 months
2. Not displaying emotional reactivity during the baseline trauma video clip provocation challenge

Primary outcomes:
measure: Posttraumatic Stress Disorder Scale (PCL-5)
timeFrame: One month follow-up assessment
Secondary outcomes:
measure: Subjective Units of Distress (SUDs)
timeFrame: One month follow-up assessment
measure: PTSD-Relevant Threat Appraisals (PTA)
timeFrame: One month follow-up assessment
measure: Coping Self-Efficacy (CSE-T-SF)
timeFrame: One month follow-up assessment
measure: PTSD Safety Behavior Inventory (PSBI)
timeFrame: One month follow-up assessment
Other outcomes:
Locations:
city: Austin
country: United States
facility: University of Texas at Austin
state: Texas
Study officials:
References:
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