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

PTSD Clinical Trial

— PFA  

Official title:

Psychological First Aid: A Randomized-controlled Trial of Adults Affected by Non-intentional Trauma in the Emergency Room

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02608086
• Other study ID #: 15-196
• Secondary ID: FONDAP 15110017/
• Status: Completed
• Phase: N/A
• First received: November 3, 2015
• Last updated: May 22, 2016
• Start date: November 2015
• Est. completion date: January 2016

Study information

• Verified date: May 2016
• Source: Pontificia Universidad Catolica de Chile
• Contact: n/a
• Is FDA regulated: No
• Health authority: Chile: Instituto de Salud Pública de ChileChile: Comisión Nacional de Investigación Científica y Tecnológica
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Emergencies
• PTSD

Intervention

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.
• 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?".

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
Pontificia Universidad Catolica de Chile

Country where clinical trial is conducted

Chile, 

References & Publications (24)

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Dieltjens T, Moonens I, Van Praet K, De Buck E, Vandekerckhove P. A systematic literature search on psychological first aid: lack of evidence to develop guidelines. PLoS One. 2014 Dec 12;9(12):e114714. doi: 10.1371/journal.pone.0114714. eCollection 2014. Review. — View Citation

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* Note: There are 24 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Self-reported depressive symptoms	According to Beck Depression Inventory	1 month	No
Other	Perceived Social Support	According to Multidimensional Scale of Perceived Social Support (MSPSS)	1 month	No
Other	Satisfaction with Intervention	According to Analog Visual Scale	Once intervention has finished, an estimate time frame of 90 minutes for "active group" or 50 minutes for "control group"	No
Other	Peri-traumatic dissociative experiences	According to PDEQ	1 month	No
Other	Peri-traumatic Distress	According to Peri-traumatic Distress Inventory (PDI)	1 month	No
Other	Previous traumatic experiences	According to TQ	1 month	No
Primary	PTSD Prevalence	PTSD prevalence according to Composite International Diagnostic Interview (CIDI)	1 month	No
Secondary	PTSD symptoms	According to the PCL-C	1 month	No

External Links

•   Link
•   CIGIDEN website
•   Psychological First Aids WHO 2012