An interventional study of Psychoeducation and Psychological First Aid in PTSD, sponsored by Pontificia Universidad Catolica de Chile. Completed at 5 sites in Chile. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-05-24.
Sponsored by Pontificia Universidad Catolica de Chile · Not applicable, Interventional, and Prevention
Psychological First Aid (PFA) is currently the most recommended early intervention for people affected by recent traumatic events, especially in the aftermath of natural disasters. Unfortunately, there is no evidence that PFA neither prevents Post-Traumatic Stress Disorder (PTSD) nor other post-traumatic disorders or symptoms of distress. This project aims to evaluate the efficacy and safety of Psychological First Aid for the prevention of PTSD and other post-traumatic disorders or symptoms.
Background: Psychological First Aid (PFA) is currently the most recommended early intervention for people affected by recent traumatic events, especially in the aftermath of natural disasters. Unfortunately, there is no evidence that PFA neither prevents Post-Traumatic Stress Disorder (PTSD) nor other post-traumatic disorders or symptoms of distress.
Objective: This project aims to evaluate the efficacy and safety of Psychological First Aid for the prevention of PTSD and other post-traumatic disorders and/or symptoms.
Population: Investigators will perform a 1:1 randomized-controlled trial of 200 adults recently affected (\<=72 hours) by a non-intentional trauma who consult to the emergency room of a public hospital. Investigators estimated a sample size of 200 individuals in order to detect a 50% Relative Risk Reduction (RRR), with a power of 80%, a statistical significance (alpha) of 5% and 34,4% of PTSD prevalence in the control group, what is consistent with prevalences observed in a similar sample by Fullerton, Ursano, Epstein, Crowley, Vance et al. (2001).
Intervention: In the emergency room, undergraduate psychology students, previously trained and certified in PFA, will search and randomize suitable patients to either PFA or treatment as usual (TAU). They will provide PFA according to a protocol based on the WHO PFA Operation Guide to those patients included in the active group. Everyone correctly randomized will be followed and clinically evaluated one month after the intervention (endpoint).
1,692 studies on the registry are indexed under Emergencies; 333 are open to participants now.
This study's enrollment of 220 is above the median of 145 across 931 interventional studies indexed under Emergencies.
Browse Emergencies studies →Pontificia Universidad Catolica de Chile is the lead sponsor of 215 studies on the registry; 56 are open to participants now.
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For example, such situations include serious accidents, catastrophic illness, highly painful medical procedures, bad medical news, natural disasters, fires, witnessing another person violent death, explosions, among others.
Exclusion Criteria:
Flyer "What can I do facing a crisis?"
Behavioral: Psychoeducation
Psychological First Aid according to an adapted protocol based on the WHO PFA Operation Guide 2012 Brochure "Network and Services" Flyer "What can I do facing a crisis?".
Behavioral: Psychological First Aid
Participants in Control Group will be delivered a flyer named "What can I do facing a crisis?", containing information about normal reactions to crisis, what to do to return to normal life and which are the signals of an initial trauma.
Psychology students (PFA Providers) will intervene according to an adapted protocol based on the WHO PFA Operation Guide 2012. Protocol for this study contemplates 4 steps: 1. Active Listening 2. Relaxing and Breathing Techniques 3. Help in prioritizing needs 4. Help in contacting network and services. Moreover, participants in this group will receive a brochure with full contact information of public network, and a flyer named "What can I do facing a crisis?".
Also known as: PFA
PTSD Prevalence
PTSD prevalence according to Composite International Diagnostic Interview (CIDI)
Time frame: 1 month
PTSD symptoms
According to the PCL-C
Time frame: 1 month
Self-reported depressive symptoms
According to Beck Depression Inventory
Time frame: 1 month
Perceived Social Support
According to Multidimensional Scale of Perceived Social Support (MSPSS)
Time frame: 1 month
Satisfaction with Intervention
According to Analog Visual Scale
Time frame: Once intervention has finished, an estimate time frame of 90 minutes for "active group" or 50 minutes for "control group"
Peri-traumatic dissociative experiences
According to PDEQ
Time frame: 1 month
Peri-traumatic Distress
According to Peri-traumatic Distress Inventory (PDI)
Time frame: 1 month
Previous traumatic experiences
According to TQ
Time frame: 1 month
This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.
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Pontificia Universidad Catolica de Chile