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| ID | Type | Description | Link |
|---|---|---|---|
| FONDAP 15110017/2011 | Other Grant/Funding Number | CIGIDEN |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Other | Flyer "What can I do facing a crisis?" |
|
| 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?". |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Psychoeducation | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| PTSD Prevalence | PTSD prevalence according to Composite International Diagnostic Interview (CIDI) | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| PTSD symptoms | According to the PCL-C | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Self-reported depressive symptoms | According to Beck Depression Inventory | 1 month |
| Perceived Social Support | According to Multidimensional Scale of Perceived Social Support (MSPSS) |
Inclusion Criteria:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Rodrigo A. Figueroa, MD | CIGIDEN | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Barros Luco Trudeau | Santiago | Santiago Metropolitan | Chile | |||
| Hospital ClÃnico UC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11495091 | Background | Breslau N. The epidemiology of posttraumatic stress disorder: what is the extent of the problem? J Clin Psychiatry. 2001;62 Suppl 17:16-22. | |
| 21517189 | Background | Carlson 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. |
| Label | URL |
|---|---|
| CIGIDEN website | View source |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| D014947 | Wounds and Injuries |
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D020969 | Disease Attributes |
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| ID | Term |
|---|---|
| D000088782 | Psychological First Aid |
| ID | Term |
|---|---|
| D004637 | Emergency Services, Psychiatric |
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
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| Psychological First Aid | Behavioral | 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?". |
|
|
| 1 month |
| 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" |
| Peri-traumatic dissociative experiences | According to PDEQ | 1 month |
| Peri-traumatic Distress | According to Peri-traumatic Distress Inventory (PDI) | 1 month |
| Previous traumatic experiences | According to TQ | 1 month |
| Santiago |
| Santiago Metropolitan |
| Chile |
| Hospital del Trabajador | Santiago | Santiago Metropolitan | Chile |
| Hospital Dr. Sótero del RÃo | Santiago | Santiago Metropolitan | Chile |
| Hospital Padre Hurtado | Santiago | Santiago Metropolitan | Chile |
| 11217152 | Background | Everly 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. |
| 11232174 | Background | Flannery RB Jr, Everly GS Jr. Crisis intervention: a review. Int J Emerg Ment Health. 2000 Spring;2(2):119-25. |
| 21910184 | Background | Friedman 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. |
| 1469374 | Background | Green 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. |
| 18181708 | Background | Hobfoll 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. |
| 22070357 | Background | Hoge 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. |
| 10761674 | Background | Kessler RC. Posttraumatic stress disorder: the burden to the individual and to society. J Clin Psychiatry. 2000;61 Suppl 5:4-12; discussion 13-4. |
| 7492257 | Background | Kessler 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. |
| 14674876 | Background | Norris 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. |
| 12555794 | Background | Ozer 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. |
| 10674950 | Background | Perkonigg 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. |
| 3776732 | Background | Ramos-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. |
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| 22766415 | Background | Rothbaum BO, Kearns MC, Price M, Malcoun E, Davis M, Ressler KJ, Lang D, Houry D. Early intervention may prevent the development of posttraumatic stress disorder: a randomized pilot civilian study with modified prolonged exposure. Biol Psychiatry. 2012 Dec 1;72(11):957-63. doi: 10.1016/j.biopsych.2012.06.002. Epub 2012 Jul 4. |
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| 22049647 | Background | Vera-Villarroel P, Zych I, Celis-Atenas K, Cordova-Rubio N, Buela-Casal G. Chilean validation of the Posttraumatic Stress Disorder Checklist-Civilian version (PCL-C) after the earthquake on February 27, 2010. Psychol Rep. 2011 Aug;109(1):47-58. doi: 10.2466/02.13.15.17.PR0.109.4.47-58. |
| 16877648 | Background | Vicente B, Kohn R, Rioseco P, Saldivia S, Levav I, Torres S. Lifetime and 12-month prevalence of DSM-III-R disorders in the Chile psychiatric prevalence study. Am J Psychiatry. 2006 Aug;163(8):1362-70. doi: 10.1176/ajp.2006.163.8.1362. |
| 21823776 | Background | Watson PJ, Brymer MJ, Bonanno GA. Postdisaster psychological intervention since 9/11. Am Psychol. 2011 Sep;66(6):482-94. doi: 10.1037/a0024806. |
| 16854253 | Background | Zlotnick C, Johnson J, Kohn R, Vicente B, Rioseco P, Saldivia S. Epidemiology of trauma, post-traumatic stress disorder (PTSD) and co-morbid disorders in Chile. Psychol Med. 2006 Nov;36(11):1523-33. doi: 10.1017/S0033291706008282. Epub 2006 Jul 20. |
| 25503520 | Background | 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. |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |