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Trial record 1 of 31 for:    psychological first aid
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Psychological First Aid (PFA): RCT Adults Non-intentional Trauma Emergency Room (PFA)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02608086
First Posted: November 18, 2015
Last Update Posted: May 24, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pontificia Universidad Catolica de Chile
  Purpose
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.

Condition Intervention
PTSD Behavioral: Psychoeducation Behavioral: Psychological First Aid

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Psychological First Aid: A Randomized-controlled Trial of Adults Affected by Non-intentional Trauma in the Emergency Room

Resource links provided by NLM:


Further study details as provided by Pontificia Universidad Catolica de Chile:

Primary Outcome Measures:
  • PTSD Prevalence [ Time Frame: 1 month ]
    PTSD prevalence according to Composite International Diagnostic Interview (CIDI)


Secondary Outcome Measures:
  • PTSD symptoms [ Time Frame: 1 month ]
    According to the PCL-C


Other Outcome Measures:
  • Self-reported depressive symptoms [ Time Frame: 1 month ]
    According to Beck Depression Inventory

  • Perceived Social Support [ Time Frame: 1 month ]
    According to Multidimensional Scale of Perceived Social Support (MSPSS)

  • Satisfaction with Intervention [ Time Frame: Once intervention has finished, an estimate time frame of 90 minutes for "active group" or 50 minutes for "control group" ]
    According to Analog Visual Scale

  • Peri-traumatic dissociative experiences [ Time Frame: 1 month ]
    According to PDEQ

  • Peri-traumatic Distress [ Time Frame: 1 month ]
    According to Peri-traumatic Distress Inventory (PDI)

  • Previous traumatic experiences [ Time Frame: 1 month ]
    According to TQ


Enrollment: 220
Study Start Date: November 2015
Study Completion Date: January 2016
Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Control
Flyer "What can I do facing a crisis?"
Behavioral: Psychoeducation
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.
Experimental: 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?".
Behavioral: Psychological First Aid
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?".
Other Name: PFA

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).

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02608086


Locations
Chile
Hospital Barros Luco Trudeau
Santiago de Chile, Santiago, Chile
Hospital Clínico UC
Santiago de Chile, Santiago, Chile
Hospital del Trabajador
Santiago de Chile, Santiago, Chile
Hospital Dr. Sótero del Río
Santiago de Chile, Santiago, Chile
Hospital Padre Hurtado
Santiago de Chile, Santiago, Chile
Sponsors and Collaborators
Pontificia Universidad Catolica de Chile
Investigators
Principal Investigator: Rodrigo A. Figueroa, MD CIGIDEN
  More Information

Additional Information:
Publications:

Responsible Party: Pontificia Universidad Catolica de Chile
ClinicalTrials.gov Identifier: NCT02608086     History of Changes
Other Study ID Numbers: 15-196
FONDAP 15110017/2011 ( Other Grant/Funding Number: CIGIDEN )
First Submitted: November 3, 2015
First Posted: November 18, 2015
Last Update Posted: May 24, 2016
Last Verified: May 2016

Keywords provided by Pontificia Universidad Catolica de Chile:
PTSD
Trauma
Emergency
RCT
Psychological First Aid

Additional relevant MeSH terms:
Emergencies
Disease Attributes
Pathologic Processes