Effects of Antagonistic Actions in Response to Trauma Exposure

NCT04617769 | Completed

• 1 other identifier: STUDY00000113
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Traumatic Stress Disorder

Keywords

post traumatic stress disorder; PTSD; psychoeducation; exposure; trauma; combat; sexual assault; physical assault; motor vehicle accident

Outcome Measures

Primary Outcomes (1)

• 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.

  One month follow-up assessment

Secondary Outcomes (4)

• Subjective Units of Distress (SUDs)

  One month follow-up assessment

• PTSD-Relevant Threat Appraisals (PTA)

  One month follow-up assessment

• Coping Self-Efficacy (CSE-T-SF)

  One month follow-up assessment

• PTSD Safety Behavior Inventory (PSBI)

  One month follow-up assessment

Study Arms (3)

Psychoeducation alone (PSYED)

PLACEBO COMPARATOR

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

Behavioral: Psychoeducation

Psychoeducation followed by exposure (PSYED+EXP)

ACTIVE COMPARATOR

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.

Behavioral: Psychoeducation; Behavioral: Exposure

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

EXPERIMENTAL

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.

Behavioral: Psychoeducation; Behavioral: Exposure

Interventions

Psychoeducation BEHAVIORAL

psychoeducational materials on trauma and safety behaviors

Psychoeducation & exposure/Antagonistic Actions (PSYED+EXP+AA); Psychoeducation alone (PSYED); Psychoeducation followed by exposure (PSYED+EXP)

Exposure BEHAVIORAL

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

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

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Texas at Austin: lead

Study Sites (1)

University of Texas at Austin

Austin, Texas, 78712, United States

Location

Related Publications (10)

• 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.

  PMID: 15740465 BACKGROUND

• 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/

  PMID: 25077185 BACKGROUND

• 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.

  PMID: 26121175 BACKGROUND

• 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.

  PMID: 10761674 BACKGROUND

• 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.

  PMID: 20104586 BACKGROUND

• Perkonigg A, Kessler RC, Storz S, Wittchen H -U. Traumatic events and post-traumatic stress disorder in the community: prevalence, risk factors and comorbidity. Acta Psychiatr Scand. 2000 Jan;101(1):46-59. doi: 10.1034/j.1600-0447.2000.101001046.x.

  PMID: 10674950 BACKGROUND

• Posner K, Brown GK, Stanley B, Brent DA, Yershova KV, Oquendo MA, Currier GW, Melvin GA, Greenhill L, Shen S, Mann JJ. The Columbia-Suicide Severity Rating Scale: initial validity and internal consistency findings from three multisite studies with adolescents and adults. Am J Psychiatry. 2011 Dec;168(12):1266-77. doi: 10.1176/appi.ajp.2011.10111704.

  PMID: 22193671 BACKGROUND

• 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.

  PMID: 18573035 BACKGROUND

• 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.

  PMID: 30600620 BACKGROUND

• Wolitzky KB, Telch MJ. Augmenting in vivo exposure with fear antagonistic actions: a preliminary test. Behav Ther. 2009 Mar;40(1):57-71. doi: 10.1016/j.beth.2007.12.006. Epub 2008 Jul 2.

  PMID: 19187817 BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Wounds and Injuries

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 30, 2020
• First Posted: November 5, 2020
• Study Start: March 22, 2021
• Primary Completion: May 15, 2023
• Study Completion: May 15, 2023
• Last Updated: January 11, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)