PTSDPFANCT02608086
Psychological First Aid (PFA): RCT Adults Non-intentional Trauma Emergency Room
A study testing Psychoeducation and Psychological First Aid in people with PTSD, run by Pontificia Universidad Catolica de Chile at 5 sites in Chile.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- PTSD
- What is being tested?
- Psychoeducation and Psychological First Aid
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 5 sitesChile
- Study dates
- Nov 2015to Jan 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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.).
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Chile5 sites
Hospital Barros Luco Trudeau
Santiago, Santiago Metropolitan
Hospital Clínico UC
Santiago, Santiago Metropolitan
Hospital del Trabajador
Santiago, Santiago Metropolitan
Hospital Dr. Sótero del Río
Santiago, Santiago Metropolitan
Hospital Padre Hurtado
Santiago, Santiago Metropolitan
About this study
Official title: Psychological First Aid: A Randomized-controlled Trial of Adults Affected by Non-intentional Trauma in the Emergency Room
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.
Read the 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).
- Conditions
- PTSD
- Being tested
- Psychoeducation, Psychological First Aid
- Keywords
- PTSD, Trauma, Emergency, RCT, Psychological First Aid
- Medical subject headings
- Stress Disorders, Post-Traumatic, Wounds and Injuries, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsychoeducationBehavioural
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 AidBehavioural
Also called PFA
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?".
| Study group | Role | What they receive |
|---|---|---|
| Control | Other | Flyer "What can I do facing a crisis?" Receives: 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?". Receives: Behavioral: Psychological First Aid |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD Prevalence
PTSD prevalence according to Composite International Diagnostic Interview (CIDI)
Measured: 1 month
Secondary outcomes (1)
PTSD symptoms
According to the PCL-C
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2015 (estimated)
- Study startNov 2015
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for PTSDStudies of the same condition, open and under way.
- More trials run by Pontificia Universidad Catolica de ChileThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidad Catolica de Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rodrigo A. Figueroa, MD, Principal investigator, CIGIDEN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02608086
- Sponsor's protocol ID
- 15-196
- Other IDs
- FONDAP 15110017/2011
- Acronym
- PFA
- Status last verified
- May 2016
- First submitted
- 3 Nov 2015
- Last updated
- 24 May 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Breslau N. The epidemiology of posttraumatic stress disorder: what is the extent of the problem? J Clin Psychiatry. 2001;62 Suppl 17:16-22.
PubMed 11495091Carlson EB, Smith SR, Palmieri PA, Dalenberg C, Ruzek JI, Kimerling R, Burling TA, Spain DA. Development and validation of a brief self-report measure of trauma exposure: the Trauma History Screen. Psychol Assess. 2011 Jun;23(2):463-77. doi: 10.1037/a0022294.
PubMed 21517189Everly GS Jr, Mitchell JT. The debriefing "controversy" and crisis intervention: a review of lexical and substantive issues. Int J Emerg Ment Health. 2000 Fall;2(4):211-25.
PubMed 11217152Flannery RB Jr, Everly GS Jr. Crisis intervention: a review. Int J Emerg Ment Health. 2000 Spring;2(2):119-25.
PubMed 11232174Friedman MJ, Resick PA, Bryant RA, Brewin CR. Considering PTSD for DSM-5. Depress Anxiety. 2011 Sep;28(9):750-69. doi: 10.1002/da.20767. Epub 2010 Dec 13.
PubMed 21910184Green BL, Lindy JD, Grace MC, Leonard AC. Chronic posttraumatic stress disorder and diagnostic comorbidity in a disaster sample. J Nerv Ment Dis. 1992 Dec;180(12):760-6. doi: 10.1097/00005053-199212000-00004.
PubMed 1469374Hobfoll SE, Watson P, Bell CC, Bryant RA, Brymer MJ, Friedman MJ, Friedman M, Gersons BP, de Jong JT, Layne CM, Maguen S, Neria Y, Norwood AE, Pynoos RS, Reissman D, Ruzek JI, Shalev AY, Solomon Z, Steinberg AM, Ursano RJ. Five essential elements of immediate and mid-term mass trauma intervention: empirical evidence. Psychiatry. 2007 Winter;70(4):283-315; discussion 316-69. doi: 10.1521/psyc.2007.70.4.283.
PubMed 18181708Hoge EA, Worthington JJ, Nagurney JT, Chang Y, Kay EB, Feterowski CM, Katzman AR, Goetz JM, Rosasco ML, Lasko NB, Zusman RM, Pollack MH, Orr SP, Pitman RK. Effect of acute posttrauma propranolol on PTSD outcome and physiological responses during script-driven imagery. CNS Neurosci Ther. 2012 Jan;18(1):21-7. doi: 10.1111/j.1755-5949.2010.00227.x. Epub 2011 Jan 10.
PubMed 22070357Kessler RC. Posttraumatic stress disorder: the burden to the individual and to society. J Clin Psychiatry. 2000;61 Suppl 5:4-12; discussion 13-4.
PubMed 10761674Kessler RC, Sonnega A, Bromet E, Hughes M, Nelson CB. Posttraumatic stress disorder in the National Comorbidity Survey. Arch Gen Psychiatry. 1995 Dec;52(12):1048-60. doi: 10.1001/archpsyc.1995.03950240066012.
PubMed 7492257Norris FH, Murphy AD, Baker CK, Perilla JL, Rodriguez FG, Rodriguez Jde J. Epidemiology of trauma and posttraumatic stress disorder in Mexico. J Abnorm Psychol. 2003 Nov;112(4):646-56. doi: 10.1037/0021-843X.112.4.646.
PubMed 14674876Ozer EJ, Best SR, Lipsey TL, Weiss DS. Predictors of posttraumatic stress disorder and symptoms in adults: a meta-analysis. Psychol Bull. 2003 Jan;129(1):52-73. doi: 10.1037/0033-2909.129.1.52.
PubMed 12555794Perkonigg A, Kessler RC, Storz S, Wittchen H -U. Traumatic events and post-traumatic stress disorder in the community: prevalence, risk factors and comorbidity. Acta Psychiatr Scand. 2000 Jan;101(1):46-59. doi: 10.1034/j.1600-0447.2000.101001046.x.
PubMed 10674950Ramos-Brieva JA, Cordero Villafafila A. [Validation of the Castillian version of the Hamilton Rating Scale for Depression]. Actas Luso Esp Neurol Psiquiatr Cienc Afines. 1986 Jul-Aug;14(4):324-34. No abstract available. Spanish.
PubMed 3776732Rose S, Bisson J, Churchill R, Wessely S. Psychological debriefing for preventing post traumatic stress disorder (PTSD). Cochrane Database Syst Rev. 2002;(2):CD000560. doi: 10.1002/14651858.CD000560.
PubMed 12076399
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological First Aid: A Randomized-controlled Trial of Adults Affected by Non-intentional Trauma in the Emergency Room
- ClinicalTrials.gov ID
- NCT02608086
- Acronym / sponsor ID
- PFA / 15-196
- Conditions
- PTSD
- Keywords
- PTSD, Trauma, Emergency, RCT, Psychological First Aid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Pontificia Universidad Catolica de ChileUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 18 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Other | Behavioral: PsychoeducationFlyer "What can I do facing a crisis?" |
| Psychological First Aid | Experimental | Behavioral: Psychological First AidPsychological 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?". |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PsychoeducationParticipants 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. | Behavioural | Control |
| Psychological First AidAlso: PFAPsychology 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?". | Behavioural | Psychological First Aid |
Primary outcome
PTSD Prevalence
Time frame: 1 month
PTSD prevalence according to Composite International Diagnostic Interview (CIDI)
1 secondary outcome
PTSD symptoms
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2016.
- Background: PubMed 11495091Breslau N. The epidemiology of posttraumatic stress disorder: what is the extent of the problem? J Clin Psychiatry. 2001;62 Suppl 17:16-22.
- Background: PubMed 21517189Carlson EB, Smith SR, Palmieri PA, Dalenberg C, Ruzek JI, Kimerling R, Burling TA, Spain DA. Development and validation of a brief self-report measure of trauma exposure: the Trauma History Screen. Psychol Assess. 2011 Jun;23(2):463-77. doi: 10.1037/a0022294.
- Background: PubMed 11217152Everly GS Jr, Mitchell JT. The debriefing "controversy" and crisis intervention: a review of lexical and substantive issues. Int J Emerg Ment Health. 2000 Fall;2(4):211-25.
- Background: PubMed 11232174Flannery RB Jr, Everly GS Jr. Crisis intervention: a review. Int J Emerg Ment Health. 2000 Spring;2(2):119-25.
- Background: PubMed 21910184Friedman MJ, Resick PA, Bryant RA, Brewin CR. Considering PTSD for DSM-5. Depress Anxiety. 2011 Sep;28(9):750-69. doi: 10.1002/da.20767. Epub 2010 Dec 13.
- Background: PubMed 1469374Green BL, Lindy JD, Grace MC, Leonard AC. Chronic posttraumatic stress disorder and diagnostic comorbidity in a disaster sample. J Nerv Ment Dis. 1992 Dec;180(12):760-6. doi: 10.1097/00005053-199212000-00004.
- Background: PubMed 18181708Hobfoll SE, Watson P, Bell CC, Bryant RA, Brymer MJ, Friedman MJ, Friedman M, Gersons BP, de Jong JT, Layne CM, Maguen S, Neria Y, Norwood AE, Pynoos RS, Reissman D, Ruzek JI, Shalev AY, Solomon Z, Steinberg AM, Ursano RJ. Five essential elements of immediate and mid-term mass trauma intervention: empirical evidence. Psychiatry. 2007 Winter;70(4):283-315; discussion 316-69. doi: 10.1521/psyc.2007.70.4.283.
- Background: PubMed 22070357Hoge EA, Worthington JJ, Nagurney JT, Chang Y, Kay EB, Feterowski CM, Katzman AR, Goetz JM, Rosasco ML, Lasko NB, Zusman RM, Pollack MH, Orr SP, Pitman RK. Effect of acute posttrauma propranolol on PTSD outcome and physiological responses during script-driven imagery. CNS Neurosci Ther. 2012 Jan;18(1):21-7. doi: 10.1111/j.1755-5949.2010.00227.x. Epub 2011 Jan 10.
- Background: PubMed 10761674Kessler RC. Posttraumatic stress disorder: the burden to the individual and to society. J Clin Psychiatry. 2000;61 Suppl 5:4-12; discussion 13-4.
- Background: PubMed 7492257Kessler RC, Sonnega A, Bromet E, Hughes M, Nelson CB. Posttraumatic stress disorder in the National Comorbidity Survey. Arch Gen Psychiatry. 1995 Dec;52(12):1048-60. doi: 10.1001/archpsyc.1995.03950240066012.
- Background: PubMed 14674876Norris FH, Murphy AD, Baker CK, Perilla JL, Rodriguez FG, Rodriguez Jde J. Epidemiology of trauma and posttraumatic stress disorder in Mexico. J Abnorm Psychol. 2003 Nov;112(4):646-56. doi: 10.1037/0021-843X.112.4.646.
- Background: PubMed 12555794Ozer EJ, Best SR, Lipsey TL, Weiss DS. Predictors of posttraumatic stress disorder and symptoms in adults: a meta-analysis. Psychol Bull. 2003 Jan;129(1):52-73. doi: 10.1037/0033-2909.129.1.52.
- CIGIDEN websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rodrigo A. Figueroa, MD principal investigator
CIGIDEN
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychoeducation and Psychological First Aid in people with PTSD, run by Pontificia Universidad Catolica de Chile at 5 sites in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PTSD Prevalence (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02608086, which also lists 24 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2016.