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

Primary Purpose

PTSD

Status
Completed
Phase
Not Applicable
Locations
Chile
Study Type
Interventional
Intervention
Psychoeducation
Psychological First Aid
Sponsored by
Pontificia Universidad Catolica de Chile
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for PTSD focused on measuring PTSD, Trauma, Emergency, RCT, Psychological First Aid

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.).

Sites / Locations

  • Hospital Barros Luco Trudeau
  • Hospital Clínico UC
  • Hospital del Trabajador
  • Hospital Dr. Sótero del Río
  • Hospital Padre Hurtado

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Control

Psychological First Aid

Arm Description

Flyer "What can I do facing a crisis?"

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?".

Outcomes

Primary Outcome Measures

PTSD Prevalence
PTSD prevalence according to Composite International Diagnostic Interview (CIDI)

Secondary Outcome Measures

PTSD symptoms
According to the PCL-C

Full Information

First Posted
November 3, 2015
Last Updated
May 22, 2016
Sponsor
Pontificia Universidad Catolica de Chile
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1. Study Identification

Unique Protocol Identification Number
NCT02608086
Brief Title
Psychological First Aid (PFA): RCT Adults Non-intentional Trauma Emergency Room
Acronym
PFA
Official Title
Psychological First Aid: A Randomized-controlled Trial of Adults Affected by Non-intentional Trauma in the Emergency Room
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pontificia Universidad Catolica de Chile

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PTSD
Keywords
PTSD, Trauma, Emergency, RCT, Psychological First Aid

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
220 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Other
Arm Description
Flyer "What can I do facing a crisis?"
Arm Title
Psychological First Aid
Arm Type
Experimental
Arm Description
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?".
Intervention Type
Behavioral
Intervention Name(s)
Psychoeducation
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Psychological First Aid
Other Intervention Name(s)
PFA
Intervention Description
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?".
Primary Outcome Measure Information:
Title
PTSD Prevalence
Description
PTSD prevalence according to Composite International Diagnostic Interview (CIDI)
Time Frame
1 month
Secondary Outcome Measure Information:
Title
PTSD symptoms
Description
According to the PCL-C
Time Frame
1 month
Other Pre-specified Outcome Measures:
Title
Self-reported depressive symptoms
Description
According to Beck Depression Inventory
Time Frame
1 month
Title
Perceived Social Support
Description
According to Multidimensional Scale of Perceived Social Support (MSPSS)
Time Frame
1 month
Title
Satisfaction with Intervention
Description
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"
Title
Peri-traumatic dissociative experiences
Description
According to PDEQ
Time Frame
1 month
Title
Peri-traumatic Distress
Description
According to Peri-traumatic Distress Inventory (PDI)
Time Frame
1 month
Title
Previous traumatic experiences
Description
According to TQ
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rodrigo A. Figueroa, MD
Organizational Affiliation
CIGIDEN
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Barros Luco Trudeau
City
Santiago de Chile
State/Province
Santiago
Country
Chile
Facility Name
Hospital Clínico UC
City
Santiago de Chile
State/Province
Santiago
Country
Chile
Facility Name
Hospital del Trabajador
City
Santiago de Chile
State/Province
Santiago
Country
Chile
Facility Name
Hospital Dr. Sótero del Río
City
Santiago de Chile
State/Province
Santiago
Country
Chile
Facility Name
Hospital Padre Hurtado
City
Santiago de Chile
State/Province
Santiago
Country
Chile

12. IPD Sharing Statement

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Links:
URL
http://www.cigiden.cl
Description
CIGIDEN website
URL
http://www.info-trauma.org
Description
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