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

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.
 
ClinicalTrials.gov Identifier: NCT02608086
Recruitment Status : Completed
First Posted : November 18, 2015
Last Update Posted : May 24, 2016
Sponsor:
Information provided by (Responsible Party):
Pontificia Universidad Catolica de Chile

Tracking Information
First Submitted Date  ICMJE November 3, 2015
First Posted Date  ICMJE November 18, 2015
Last Update Posted Date May 24, 2016
Study Start Date  ICMJE November 2015
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 17, 2015)
PTSD Prevalence [ Time Frame: 1 month ]
PTSD prevalence according to Composite International Diagnostic Interview (CIDI)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 17, 2015)
PTSD symptoms [ Time Frame: 1 month ]
According to the PCL-C
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: November 17, 2015)
  • 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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Psychological First Aid (PFA): RCT Adults Non-intentional Trauma Emergency Room
Official Title  ICMJE Psychological First Aid: A Randomized-controlled Trial of Adults Affected by Non-intentional Trauma in the Emergency Room
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE PTSD
Intervention  ICMJE
  • 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.
  • 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
Study Arms  ICMJE
  • Control
    Flyer "What can I do facing a crisis?"
    Intervention: Behavioral: Psychoeducation
  • 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?".
    Intervention: Behavioral: Psychological First Aid
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 22, 2016)
220
Original Estimated Enrollment  ICMJE
 (submitted: November 17, 2015)
200
Actual Study Completion Date  ICMJE January 2016
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Chile
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02608086
Other Study ID Numbers  ICMJE 15-196
FONDAP 15110017/2011 ( Other Grant/Funding Number: CIGIDEN )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pontificia Universidad Catolica de Chile
Study Sponsor  ICMJE Pontificia Universidad Catolica de Chile
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Rodrigo A. Figueroa, MD CIGIDEN
PRS Account Pontificia Universidad Catolica de Chile
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP