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Effects of Antagonistic Actions in Response to Trauma Exposure

Primary Purpose

Post Traumatic Stress Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Psychoeducation
Exposure
Sponsored by
University of Texas at Austin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Traumatic Stress Disorder focused on measuring post traumatic stress disorder, PTSD, psychoeducation, exposure, trauma, combat, sexual assault, physical assault, motor vehicle accident

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Texas at AustinRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Experimental

Arm Label

Psychoeducation alone (PSYED)

Psychoeducation followed by exposure (PSYED+EXP)

Psychoeducation & exposure/Antagonistic Actions (PSYED+EXP+AA)

Arm Description

The participant will receive both PDF and video materials involving psychoeducational materials on trauma and safety behaviors.

The participant will receive both PDF and video materials involving psychoeducational materials on trauma and safety behaviors. The participant will then be instructed to start the trauma video clip exposures. There will be 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 should it become activated.

The participant will receive both PDF and video materials involving psychoeducational materials on trauma and safety behaviors. The participant will then be instructed to start the trauma video clip exposures. There will be 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 should it become activated. 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"). The participant will engage in all of the four antagonistic actions for the six exposure trials.

Outcomes

Primary Outcome Measures

Posttraumatic Stress Disorder Scale (PCL-5)
Change from baseline in patient-rated PTSD severity. The subjective 20-item self-report measure assesses the 20 DSM-5 symptoms of PTSD, and is rated on a 5-point Likert-style scale (0 = not at all to 4 = extremely) with a maximum score of 80 indicating extreme distress from PTSD symptoms.

Secondary Outcome Measures

Subjective Units of Distress (SUDs)
Change from baseline in patient-rated subjective and behavioral indices of emotional reactivity to a new trauma-relevant videoclip, where higher scores indicate more distress.
PTSD-Relevant Threat Appraisals (PTA)
Change from baseline in patient-rated PTSD-relevant threat appraisals, where higher score indicate greater perceived threat towards the trauma video clip.
Coping Self-Efficacy (CSE-T-SF)
Change from baseline in patient-rated coping self-efficacy, where higher scores indicate greater perceptions of trauma-related self-efficacy coping
PTSD Safety Behavior Inventory (PSBI)
Change from baseline in patient-rated trauma-related safety behaviors, where higher scores indicate greater usage of PTSD-related safety behaviors.

Full Information

First Posted
October 30, 2020
Last Updated
June 8, 2022
Sponsor
University of Texas at Austin
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1. Study Identification

Unique Protocol Identification Number
NCT04617769
Brief Title
Effects of Antagonistic Actions in Response to Trauma Exposure
Official Title
Effects of Antagonistic Actions in Response to Trauma Exposure
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 22, 2021 (Actual)
Primary Completion Date
May 15, 2023 (Anticipated)
Study Completion Date
May 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas at Austin

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Traumatic Stress Disorder
Keywords
post traumatic stress disorder, PTSD, psychoeducation, exposure, trauma, combat, sexual assault, physical assault, motor vehicle accident

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Psychoeducation alone (PSYED)
Arm Type
Placebo Comparator
Arm Description
The participant will receive both PDF and video materials involving psychoeducational materials on trauma and safety behaviors.
Arm Title
Psychoeducation followed by exposure (PSYED+EXP)
Arm Type
Active Comparator
Arm Description
The participant will receive both PDF and video materials involving psychoeducational materials on trauma and safety behaviors. The participant will then be instructed to start the trauma video clip exposures. There will be 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 should it become activated.
Arm Title
Psychoeducation & exposure/Antagonistic Actions (PSYED+EXP+AA)
Arm Type
Experimental
Arm Description
The participant will receive both PDF and video materials involving psychoeducational materials on trauma and safety behaviors. The participant will then be instructed to start the trauma video clip exposures. There will be 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 should it become activated. 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"). The participant will engage in all of the four antagonistic actions for the six exposure trials.
Intervention Type
Behavioral
Intervention Name(s)
Psychoeducation
Intervention Description
psychoeducational materials on trauma and safety behaviors
Intervention Type
Behavioral
Intervention Name(s)
Exposure
Intervention Description
six 3-minute video exposure trials with an inter-trial interval of 2 minutes
Primary Outcome Measure Information:
Title
Posttraumatic Stress Disorder Scale (PCL-5)
Description
Change from baseline in patient-rated PTSD severity. The subjective 20-item self-report measure assesses the 20 DSM-5 symptoms of PTSD, and is rated on a 5-point Likert-style scale (0 = not at all to 4 = extremely) with a maximum score of 80 indicating extreme distress from PTSD symptoms.
Time Frame
One month follow-up assessment
Secondary Outcome Measure Information:
Title
Subjective Units of Distress (SUDs)
Description
Change from baseline in patient-rated subjective and behavioral indices of emotional reactivity to a new trauma-relevant videoclip, where higher scores indicate more distress.
Time Frame
One month follow-up assessment
Title
PTSD-Relevant Threat Appraisals (PTA)
Description
Change from baseline in patient-rated PTSD-relevant threat appraisals, where higher score indicate greater perceived threat towards the trauma video clip.
Time Frame
One month follow-up assessment
Title
Coping Self-Efficacy (CSE-T-SF)
Description
Change from baseline in patient-rated coping self-efficacy, where higher scores indicate greater perceptions of trauma-related self-efficacy coping
Time Frame
One month follow-up assessment
Title
PTSD Safety Behavior Inventory (PSBI)
Description
Change from baseline in patient-rated trauma-related safety behaviors, where higher scores indicate greater usage of PTSD-related safety behaviors.
Time Frame
One month follow-up assessment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18 to 60 Speaks English fluently Identify either an assault, motor vehicle accident, or combat index trauma on the LEC-5 Access to the internet Willingness to provide signed informed consent Willingness to refrain from all non-study trauma-focused treatment during the study period Exclusion Criteria: History of a suicide attempt within the past 6 months Not displaying emotional reactivity during the baseline trauma video clip provocation challenge
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael J Telch, PhD
Phone
5125604100
Email
telch@austin.utexas.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Emma Siegel, MA
Phone
8587177089
Email
eysiegel@utexas.edu
Facility Information:
Facility Name
University of Texas at Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78712
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Telch, PhD
Phone
512-560-4100
Email
telch@austin.utexas.edu
First Name & Middle Initial & Last Name & Degree
Emma Siegel, MA
Phone
8587177089
Email
eysiegel@utexas.edu
First Name & Middle Initial & Last Name & Degree
Michael Telch, PhD
First Name & Middle Initial & Last Name & Degree
Emma Siegel, MA

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
15740465
Citation
Frans O, Rimmo PA, Aberg L, Fredrikson M. Trauma exposure and post-traumatic stress disorder in the general population. Acta Psychiatr Scand. 2005 Apr;111(4):291-9. doi: 10.1111/j.1600-0447.2004.00463.x.
Results Reference
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PubMed Identifier
25077185
Citation
Committee on the Assessment of Ongoing Efforts in the Treatment of Posttraumatic Stress Disorder; Board on the Health of Select Populations; Institute of Medicine. Treatment for Posttraumatic Stress Disorder in Military and Veteran Populations: Final Assessment. Washington (DC): National Academies Press (US); 2014 Jun 17. Available from http://www.ncbi.nlm.nih.gov/books/NBK224878/
Results Reference
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PubMed Identifier
26121175
Citation
Kehle-Forbes SM, Meis LA, Spoont MR, Polusny MA. Treatment initiation and dropout from prolonged exposure and cognitive processing therapy in a VA outpatient clinic. Psychol Trauma. 2016 Jan;8(1):107-114. doi: 10.1037/tra0000065. Epub 2015 Jun 29.
Results Reference
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PubMed Identifier
10761674
Citation
Kessler RC. Posttraumatic stress disorder: the burden to the individual and to society. J Clin Psychiatry. 2000;61 Suppl 5:4-12; discussion 13-4.
Results Reference
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PubMed Identifier
20104586
Citation
McDevitt-Murphy ME, Williams JL, Bracken KL, Fields JA, Monahan CJ, Murphy JG. PTSD symptoms, hazardous drinking, and health functioning among U.S.OEF and OIF veterans presenting to primary care. J Trauma Stress. 2010 Feb;23(1):108-11. doi: 10.1002/jts.20482.
Results Reference
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PubMed Identifier
10674950
Citation
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
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Citation
Schottenbauer MA, Glass CR, Arnkoff DB, Tendick V, Gray SH. Nonresponse and dropout rates in outcome studies on PTSD: review and methodological considerations. Psychiatry. 2008 Summer;71(2):134-68. doi: 10.1521/psyc.2008.71.2.134.
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PubMed Identifier
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Citation
Shalev AY, Gevonden M, Ratanatharathorn A, Laska E, van der Mei WF, Qi W, Lowe S, Lai BS, Bryant RA, Delahanty D, Matsuoka YJ, Olff M, Schnyder U, Seedat S, deRoon-Cassini TA, Kessler RC, Koenen KC; International Consortium to Predict PTSD. Estimating the risk of PTSD in recent trauma survivors: results of the International Consortium to Predict PTSD (ICPP). World Psychiatry. 2019 Feb;18(1):77-87. doi: 10.1002/wps.20608.
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Citation
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Links:
URL
https://psychnews.psychiatryonline.org/doi/full/10.1176/pn.46.11.psychnews_46_11_4_1
Description
IOM investigates effectiveness of current PTSD treatments

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Effects of Antagonistic Actions in Response to Trauma Exposure

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