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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

220

participants targeted

Target at P75+ for not_applicable

Timeline

Completed

Started Nov 2015

Shorter than P25 for not_applicable

Geographic Reach

1 country

5 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

2 months study duration

Study Start

First participant enrolled

November 1, 2015

Completed

2 days until next milestone

First Submitted

Initial submission to the registry

November 3, 2015

Completed

15 days until next milestone

First Posted

Study publicly available on registry

November 18, 2015

Completed

1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed

Last Updated

May 24, 2016

Status Verified

May 1, 2016

Enrollment Period

2 months

First QC Date

November 3, 2015

Last Update Submit

May 22, 2016

Conditions

PTSD

Keywords

PTSDTraumaEmergencyRCTPsychological First Aid

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

PTSD symptoms
1 month

Other Outcomes (6)

Self-reported depressive symptoms
1 month
Perceived Social Support
1 month
Satisfaction with Intervention
Once intervention has finished, an estimate time frame of 90 minutes for "active group" or 50 minutes for "control group"
+3 more other outcomes

Study Arms (2)

Control

OTHER

Flyer "What can I do facing a crisis?"

Behavioral: Psychoeducation

Psychological First Aid

EXPERIMENTAL

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

Interventions

PsychoeducationBEHAVIORAL

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.

Control

Psychological First AidBEHAVIORAL

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

Psychological First Aid

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

You may not qualify if:

Does not understand Spanish
Child and adolescent (\< 18 years old)
Can not remember traumatic experience recently experienced
Psychosis (loss of reality testing)
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.).

Contact the study team to confirm eligibility.