Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2020-02-01
2023-01-01
Brief Summary
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It is hypothesized that participants in both psychoeducation conditions will have a lower incidence of PTSD, threat appraisal, and safety behaviors than participants in the monitoring-only control. It is also hypothesized that participants who receive combined psychoeducation on trauma symptoms and fading safety behaviors will have a lower incidence of PTSD, threat appraisal, and safety behaviors at Weeks 4 and 8 than will participants who receive psychoeducation on trauma symptoms only or participants in the monitoring-only control. It is further hypothesized that the effects of combined psychoeducation on preventing PTSD and threat appraisal will be mediated by decreased use of safety behaviors. Finally, it is hypothesized that combined psychoeducation on trauma symptoms and fading safety behaviors will be more effective in preventing PTSD for participants with higher levels of safety behaviors or threat appraisal at baseline. If effective, this secondary prevention program could be distributed widely to people who have recently experienced a trauma to prevent their development of PTSD.
Detailed Description
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Randomization Immediately after baseline assessment, each participant will be automatically randomized into one of three study conditions. Randomization will be stratified based on number and severity of safety behaviors used and level of Acute Stress Disorder symptoms reported at baseline. Once randomized, participants in the two psychoeducation conditions will immediately receive psychoeducation materials, and all participants will receive rationale for their study condition, as specified below. All three conditions will complete the same schedule of assessments.
Conditions
Condition 1: Psychoeducation on trauma symptoms (PSYED-T) In Condition 1, participants will receive view a psychoeducation handout and video on trauma symptoms. Participants in this condition will also receive a rationale stating that learning about the nature of trauma reactions as well as monitoring trauma reactions and safety behaviors are important for preventing development of PTSD.
Condition 2: Combined psychoeducation on trauma symptoms and fading safety behaviors (PSYED-T+SB) Participants in Condition 2 will receive view a psychoeducation handout and video on trauma symptoms and on safety behaviors and how to fade them. Participants in this condition will also receive a rationale stating that learning about the nature of trauma reactions, learning to eliminate safety behaviors, and monitoring trauma reactions and safety behaviors are important in the prevention of PTSD.
Because it is expected that the psychoeducational information provided in PSYED-T+SB condition to be beneficial to participants, all participants will receive this information upon completion of the study.
Condition 3: Monitoring-only control Condition 3 will be a monitoring-only control and thus will receive no psychoeducation handouts or videos. Participants in this condition will receive a rationale that monitoring trauma reactions and safety behaviors is important in the prevention of PTSD development.
Psychoeducation At baseline, participants will receive a web link to the psychoeducation materials via email. Participants will then be instructed to carefully read the handout and watch the video and encouraged to revisit the materials throughout the course of the study. Immediately following baseline exposure to psychoeducation materials, all participants will complete a short quiz applicable to the psychoeducation and/or monitoring involved in their condition in order to ensure comprehension of the materials. Reading the psychoeducation materials, watching the video(s), and completing the quiz is expected to take participants approximately 30 minutes.
Participants will have unlimited access to the handouts and videos through a web link for the entire course of the study. Using REDCap, researchers will monitor the number of times each participant accesses psychoeducation materials during the study.
Weekly Assessments All participants will complete weekly assessments of trauma symptoms, threat appraisal, and safety behavior. Compliance with self-monitoring will be controlled for in all analyses.
Weeks 4 and 8 Assessments At Week 4 and Week 8, participants will complete a comprehensive assessment of all primary and secondary outcomes. Because the timing of onset of PTSD is variable among patients (Frueh, Grubaugh, Yeager, \& Magruder, 2009), PTSD diagnosis will be assessed at Week 4 and Week 8. The psychoeducation quiz will also be administered at Weeks 4 and 8 to assess for comprehension and retention of the psychoeducational information.
Phone Interview The PSSI-5 interview will also be conducted over the phone for any participants who screen positive for PTSD at Week 4 or Week 8 based on the PSSI-5 self-report scale. The PSSI-5 phone interview will take approximately 20 minutes at each administration and will be audio recorded in order to assess inter-rater reliability of PTSD diagnosis.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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PSYED-T
In PSYED-T (psychoeducation on trauma symptoms), participants will receive a psychoeducation handout and watch a related video on common reactions to trauma. Participants in this condition will also receive a rationale stating that both learning about the nature of trauma reactions and monitoring symptoms are important for preventing development of PTSD.
Psychoeducation on trauma reactions
The psychoeducation handout and video on trauma symptoms will discuss reactions that are common after experiencing a trauma.
PSYED-T+SB
Participants in PSYED-T+SB (Combined psychoeducation on trauma reactions and safety behaviors) will receive psychoeducation handouts and videos on the nature of trauma symptoms and the nature of safety behaviors and how to fade them. Participants in this condition will also receive a rationale stating that learning about the nature of trauma reactions and safety behaviors, learning to fade safety behaviors, and monitoring symptoms are important in the prevention of PTSD.
Psychoeducation on trauma reactions
The psychoeducation handout and video on trauma symptoms will discuss reactions that are common after experiencing a trauma.
Psychoeducation on safety behaviors
The psychoeducation handout and video on safety behaviors will discuss safety behaviors that are common in PTSD and tips for how to eliminate them.
Monitoring-only control
The third condition will be a monitoring-only control and thus will receive no psychoeducation information. Participants in the control condition will receive a rationale that monitoring symptoms is important in the prevention of PTSD development.
No interventions assigned to this group
Interventions
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Psychoeducation on trauma reactions
The psychoeducation handout and video on trauma symptoms will discuss reactions that are common after experiencing a trauma.
Psychoeducation on safety behaviors
The psychoeducation handout and video on safety behaviors will discuss safety behaviors that are common in PTSD and tips for how to eliminate them.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have regular access to the internet and email for eight weeks
* Have experienced a Criterion A trauma within the past 30 days, as assessed by the Life Events Checklist for DSM-5 (LEC-5; Weathers et al., 2013a)
Exclusion Criteria
* Current suicidal intent, as measured by Beck Depression Inventory (BDI-II) suicidality item
* Immediate risk to others
* Have experienced a traumatic brain injury or other serious neurocognitive impairment in the past six months.
* Prior history of PTSD
18 Years
65 Years
ALL
No
Sponsors
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University of Texas at Austin
OTHER
Responsible Party
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Michael J. Telch
Professor
Principal Investigators
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Michael J Telch, PhD
Role: PRINCIPAL_INVESTIGATOR
The University of Texas at Austin
Other Identifiers
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2017-11-0001
Identifier Type: -
Identifier Source: org_study_id