Psychological First Aid (PFA): RCT Adults Non-intentional Trauma Emergency Room

Not Applicable

Completed

• Conditions: PTSD
• Interventions: Behavioral: Psychological First Aid; Behavioral: Psychoeducation

• Registration Number: NCT02608086
• Lead Sponsor: Pontificia Universidad Catolica de Chile

Brief Summary

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.

Detailed Description

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).

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2015-11-03
• Study First Submitted QC: 2015-11-17
• Study First Posted: 2015-11-18
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-22
• Last Update Posted: 2016-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

• Adults (≥ 18 years old) concurring to the emergency room, either as a patient himself or companion, who have been victims of a recent unintentional trauma (less than 72 hours ago), and meet one of the following criteria:
• Direct victim, as a family or as a witness, of a situation that was or is currently life threatening.
• Direct victim, as a family or as a witness, of a situation that affected or currently seriously endangers the physical integrity.

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

• Does not understand Spanish
• Child and adolescent (< 18 years old)
• Can not remember traumatic experience recently experienced
• Psychosis (loss of reality testing)
• People in life-threatening or health instability situation, requiring equipment for life support incompatible with this application protocol (serious fractures, severe bleeding wounds with uncontrolled excruciating pain, unstable myocardial infarction, etc.). Will be the attending physician whom inform the patient if this exclusion criterion is met.
• Relatives of people in imminent life-threatening or recently died in the emergency room where the offer to participate in the research can cause even greater discomfort.
• Impairment of consciousness (Glasgow < 15)
• Intoxication
• Loss of consciousness for more than 5 minutes.
• Direct and indirect victims of intentional trauma (eg. assault, kidnapping, sexual abuse, terrorist attack, etc).
• Patients being treated for a psychiatric disorder diagnosed by a doctor (personality disorder is excluded) (eg. schizophrenia, mental retardation, autism, obsessive compulsive disorder, bipolar disorder, depression, Alzheimer's disease, panic disorder, etc.).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Psychological First Aid	Psychological First Aid	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?".
Control	Psychoeducation	Flyer "What can I do facing a crisis?"

Primary Outcome Measures

Name	Time	Method
PTSD Prevalence	1 month	PTSD prevalence according to Composite International Diagnostic Interview (CIDI)

Secondary Outcome Measures

Name	Time	Method
PTSD symptoms	1 month	According to the PCL-C

Trial Locations

Locations (5)

Hospital Clínico UC; 🇨🇱 Santiago de Chile, Santiago, Chile

Hospital del Trabajador; 🇨🇱 Santiago de Chile, Santiago, Chile

Hospital Padre Hurtado; 🇨🇱 Santiago de Chile, Santiago, Chile

Hospital Barros Luco Trudeau; 🇨🇱 Santiago de Chile, Santiago, Chile

Hospital Dr. Sótero del Río; 🇨🇱 Santiago de Chile, Santiago, Chile