Posttraumatic Stress Disorder Clinical Trial
Official title:
Prevention of Mental Health Problems in People Exposed to a Recent Highly Stressful Event: a Randomized Controlled Study
NCT number | NCT04314115 |
Other study ID # | 1180134 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 1, 2018 |
Est. completion date | March 30, 2021 |
Verified date | January 2022 |
Source | Universidad Santo Tomas, Chile |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This project evaluates the effectiveness of three intervention models for the prevention of mental health problems in people who have suffered a recent highly stressful event, through an experimental design, with a control group and random assignment of participants in each group . The preventive interventions that will be evaluated will be based on three different psychotherapeutic models: brief systemic therapy, cognitive behavioral therapy and mindfulness. It is expected to observe a significant reduction in post-traumatic and depressive symptoms, and an increase in subjective well-being and post-traumatic growth, compared to the control group. In addition, the moderating effect of psychological processes such as cognitive rumination, emotional self-regulation and coping strategies used in the relationship between the type of intervention and its results will be evaluated. If the hypotheses are confirmed, this study will allow the prevention of emotional distress associated with a highly stressful event, as well as the promotion of positive results, through empirically supported, low-cost strategies and with results that are capable of demonstrating their effectiveness.
Status | Completed |
Enrollment | 160 |
Est. completion date | March 30, 2021 |
Est. primary completion date | March 30, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Inclusion criteria will be to be of legal age and to have lived the highly stressful experience in the last three months (a check-list of events will be available). Exclusion Criteria: - Those who have already been previously given psychological care will be excluded due to the consequences generated by the same event and who, due to their health condition, are prevented from receiving individual care in the first three months after the event. |
Country | Name | City | State |
---|---|---|---|
Chile | Universidad Santo Tomas | Concepción |
Lead Sponsor | Collaborator |
---|---|
Universidad Santo Tomas, Chile | Universidad de Concepcion |
Chile,
Alarcón, R. (2002). Trastorno por estrés postraumático: estudios en veteranos de guerra norteamericanos y su relevancia para América Latina. Revista Chilena de Neuro-psiquiatría, 40, 35-47.
Altindag A, Ozen S, Sir A. One-year follow-up study of posttraumatic stress disorder among earthquake survivors in Turkey. Compr Psychiatry. 2005 Sep-Oct;46(5):328-33. — View Citation
Alzugaray, C., García, F., Reyes, A., & Álvarez, R. (2015). Propiedades psicométricas de una versión breve de la escala de rumiación relacionada a un evento en población chilena afectada por eventos altamente estresantes. Ajayu, 13(2), 183-198.
Amutio-Kareaga A, García-Campayo J, Delgado LC, Hermosilla D, Martínez-Taboada C. Improving Communication between Physicians and Their Patients through Mindfulness and Compassion-Based Strategies: A Narrative Review. J Clin Med. 2017 Mar 17;6(3). pii: E33. doi: 10.3390/jcm6030033. Review. — View Citation
Andrades M, García FE, Reyes-Reyes A, Martínez-Arias R, Calonge I. Psychometric properties of the Posttraumatic Growth Inventory for Children in Chilean population affected by the earthquake of 2010. Am J Orthopsychiatry. 2016;86(6):686-692. Epub 2016 May 23. — View Citation
Andrades, M., García, F., Calonge. I., & Martínez-Arias, R. (2017). Posttraumatic growth in children and adolescents exposed to the 2010 earthquake in Chile and its relationship with rumination and posttraumatic stress symptoms. Journal of Happiness Studies, 1-13.
Avilés, P., Cova, F., Bustos, C., & García, F.E. (2014). Afrontamiento y rumiación frente a eventos adversos y crecimiento postraumático en estudiantes universitarios. Liberabit, 20(2), 281-292.
Baron RM, Kenny DA. The moderator-mediator variable distinction in social psychological research: conceptual, strategic, and statistical considerations. J Pers Soc Psychol. 1986 Dec;51(6):1173-82. — View Citation
Basoglu M, Livanou M, Salcioglu E. A single session with an earthquake simulator for traumatic stress in earthquake survivors. Am J Psychiatry. 2003 Apr;160(4):788-90. — View Citation
Beyebach, M. (2006). 24 ideas para una psicoterapia breve. Barcelona: Herder.
Beyebach, M. (2014). Change factors in solution-focused brief therapy: A review of the Salamanca studies. Journal of Systemic Therapies, 33(1), 62-77.
Breslau N, Kessler RC, Chilcoat HD, Schultz LR, Davis GC, Andreski P. Trauma and posttraumatic stress disorder in the community: the 1996 Detroit Area Survey of Trauma. Arch Gen Psychiatry. 1998 Jul;55(7):626-32. — View Citation
Breslau N. Epidemiologic studies of trauma, posttraumatic stress disorder, and other psychiatric disorders. Can J Psychiatry. 2002 Dec;47(10):923-9. Review. — View Citation
Cann A, Calhoun LG, Tedeschi RG, Triplett KN, Vishnevsky T, Lindstrom CM. Assessing posttraumatic cognitive processes: the Event Related Rumination Inventory. Anxiety Stress Coping. 2011 Mar;24(2):137-56. doi: 10.1080/10615806.2010.529901. — View Citation
Carver CS. You want to measure coping but your protocol's too long: consider the brief COPE. Int J Behav Med. 1997;4(1):92-100. — View Citation
Cerna C, García FE, Téllez A. Brief mindfulness, mental health, and cognitive processes: A randomized controlled trial. Psych J. 2020 Jun;9(3):359-369. doi: 10.1002/pchj.325. Epub 2019 Dec 5. — View Citation
Chaves, C., Hervás, G. & García, F. & Vázquez, C. (2015). Building life satisfaction through well-being dimensions: A longitudinal study in children with a life-threatening illness. Journal of Happiness Studies, 17(3), 1051-1067.
Cova, F., Rincón, P., & Melipillán, R. (2009). Reflexión, rumiación negativa y desarrollo de sintomatología depresiva en adolescentes de sexo femenino. Terapia Psicológica, 27(2), 155-160.
Creamer M, McFarlane AC, Burgess P. Psychopathology following trauma: the role of subjective experience. J Affect Disord. 2005 Jun;86(2-3):175-82. — View Citation
Díaz, C. A., Quintana, G. R., & Vogel, E. H. (2012). Síntomas de depresión, ansiedad y estrés posttraumático en adolescentes siete meses después del terremoto del 27 de febrero de 2010 en Chile. Terapia Psicológica, 30(1), 37-43.
Diener E, Emmons RA, Larsen RJ, Griffin S. The Satisfaction With Life Scale. J Pers Assess. 1985 Feb;49(1):71-5. — View Citation
Fernández AR, Estario JC, Enders JE, Neira MJ, Abeldaño RA. [Screening for posttraumatic stress disorder in people affected by the 2010 earthquake in Chile.]. Cad Saude Publica. 2014 Nov;30(11):2377-2386. Spanish. — View Citation
García FE, Cova F, Rincón P, Vázquez C. Trauma or growth after a natural disaster? The mediating role of rumination processes. Eur J Psychotraumatol. 2015 Jul 31;6:26557. doi: 10.3402/ejpt.v6.26557. eCollection 2015. — View Citation
García FE, Duque A, Cova F. The four faces of rumination to stressful events: A psychometric analysis. Psychol Trauma. 2017 Nov;9(6):758-765. doi: 10.1037/tra0000289. Epub 2017 Jun 8. — View Citation
García, F. & Ceberio, M.R. (2016). Manual de terapia sistémica breve. Santiago de Chile: Mediterráneo.
García, F. & Ilabaca, D. (2013). Ruptura de la pareja, afrontamiento y bienestar psicológico en adultos jóvenes. Ajayu, 11(2), 157-172.
García, F. & Mardones, R. (2010). Prevención de trastorno de estrés postraumático en supervivientes del terremoto de Chile de febrero de 2010: una propuesta de intervención narrativa. Terapia psicológica, 28(1), 85-93.
García, F. & Rincón, P. (2011). Prevención de sintomatología postraumática en mujeres diagnosticada con cáncer de mama: Evaluación preliminar de un modelo de intervención narrativo. Terapia Psicológica, 29(2), 175-183.
García, F. & Wlodarczyk, A. (2015). Psychometric Properties of the Post-traumatic Growth Inventory - Short Form among Chilean Adults. Journal of Loss and Trauma. 21(4), 303-314.
García, F. (2013). Terapia sistémica breve. Fundamentos y aplicaciones (1ra. edición). Santiago de Chile: RIL.
García, F., Cova, F. & Melipillán, R. (2013). Propiedades psicométricas del Inventario de Crecimiento Postraumático en población chilena afectada por un desastre natural. Revista Mexicana de Psicología, 30 (2), 145-153.
García, F., Jaramillo, C., Martínez, A.M., Valenzuela, I. & Cova, F. (2014). Respuestas psicológicas ante un desastre natural: Estrés y crecimiento postraumático. Liberabit, 20, 121-130.
García, F., Páez, D., Cartes, G., Neira, H. & Reyes, A. (2014). Religious coping, social support and subjective severity as predictors of posttraumatic growth in people affected by the earthquake in Chile on 27/F 2010. Religions, 5, 1132-1145.
García, F., Páez, D., Reyes, A. & Álvarez, R. (2017). Religious coping as moderator of psychological responses to stressful events: A longitudinal study. Religions, 8(62), 1-13.
García, F., Wlodarczyk, A., Reyes, A., San Cristóbal, C. & Solar, C. (2014). Violencia en la pareja, apoyo social y bienestar psicológico en adultos jóvenes. Ajayu, 12 (2), 246-265.
García-Campayo, J. & Demarzo, M. (2015). Mindfulness y compasión: La nueva revolución. Barcelona: Siglantama.
Gempp, R., Avendaño, C., & Muñoz, C. (2004). Normas y punto de corte para la Escala de Depresión del Centro para Estudios Epidemiológicos (CES-D) en población juvenil chilena. Terapia Psicológica, 22(2), 145-156.
Gómez, A. & Cárdenas, G. (2016). Reacciones postraumáticas: revisión desde una perspectiva dimensional. Psicología Iberoamericana, 24(1), 70-79.
Gross JJ, John OP. Individual differences in two emotion regulation processes: implications for affect, relationships, and well-being. J Pers Soc Psychol. 2003 Aug;85(2):348-62. — View Citation
Guerra, C., & Plaza, H. (2009). Tratamiento Cognitivo-Conductual del Estrés Postraumático en un caso de violación infantil. Revista de Psicología, 18(1), 103-129.
Kuoppala J, Lamminpää A, Väänänen-Tomppo I, Hinkka K. Employee well-being and sick leave, occupational accident, and disability pension: a cohort study of civil servants. J Occup Environ Med. 2011 Jun;53(6):633-40. doi: 10.1097/JOM.0b013e31821aa48c. — View Citation
Leiva-Bianchi, M.C., & Gallardo, I. (2013). Validación de la escala breve para diagnosticar estrés posttraumático (SPRINT-E) en una muestra de personas afectadas por el terremoto y tsunami del 27-F en Chile. Anales de Psicología, 29(2), 328-334.
MacKinnon DP, Lockwood CM, Hoffman JM, West SG, Sheets V. A comparison of methods to test mediation and other intervening variable effects. Psychol Methods. 2002 Mar;7(1):83-104. — View Citation
Mackinnon DP, Lockwood CM, Williams J. Confidence Limits for the Indirect Effect: Distribution of the Product and Resampling Methods. Multivariate Behav Res. 2004 Jan 1;39(1):99. — View Citation
Meichenbaum, D. (1975). Self-instructional methods. En F.H. Kanfer & A.P. Goldstein (Eds.), Helping people change (pp. 357-391). New York: Pergamon Press.
Morán C., Landero R., & González M. (2010). COPE-28: Un análisis psicométrico de la versión en español del Brief COPE. Universitas Psychologica, 9(2), 543-552.
Morris BA, Shakespeare-Finch J. Rumination, post-traumatic growth, and distress: structural equation modelling with cancer survivors. Psychooncology. 2011 Nov;20(11):1176-83. doi: 10.1002/pon.1827. Epub 2010 Aug 23. — View Citation
Moyano, E., & Ramos, N. (2007). Bienestar subjetivo: Midiendo satisfacción vital, felicidad y salud en la población chilena de la Región del Maule. Universum, 22(2), 177-193.
Norris FH, Hamblen JL, Brown LM, Schinka JA. Validation of the Short Posttraumatic Stress Disorder Rating Interview (expanded version, Sprint-E) as a measure of postdisaster distress and treatment need. Am J Disaster Med. 2008 Jul-Aug;3(4):201-12. — View Citation
Organización Mundial de la Salud (2004). Prevención de los Trastornos Mentales: Intervenciones efectivas y opciones de políticas informe compendiado. Recuperado el 20 de mayo, 2017, http://www.who.int/mental_health/evidence/Prevention_of_mental_disorders_spanish_version.pdf
Pargament, K., Feuille, M., & Burdzy, D. (2011). The Brief RCOPE: Current psychometric status of a short measure of religious coping. Religions, 2, 51-76.
Powers MB, Halpern JM, Ferenschak MP, Gillihan SJ, Foa EB. A meta-analytic review of prolonged exposure for posttraumatic stress disorder. Clin Psychol Rev. 2010 Aug;30(6):635-41. doi: 10.1016/j.cpr.2010.04.007. Epub 2010 May 2. — View Citation
Radloff, L. (1977). The CES-D scale: A self-report depression scale for research in the general population. Applied Psychological Measurement, 1(3), 385-401.
Rajandram RK, Jenewein J, McGrath C, Zwahlen RA. Coping processes relevant to posttraumatic growth: an evidence-based review. Support Care Cancer. 2011 May;19(5):583-9. doi: 10.1007/s00520-011-1105-0. Epub 2011 Feb 6. Review. — View Citation
Rivera, A., & Montero, L. (2005). Espiritualidad y religiosidad en adultos mayores mexicanos. Salud Mental, 28, 51-58
Rodríguez-Carvajal, R., Moreno-Jiménez, B. & Garrosa, E. (2006). Cuestionario de Regulación Emocional - Versión española. Madrid: Universidad Autónoma de Madrid
Salsman JM, Segerstrom SC, Brechting EH, Carlson CR, Andrykowski MA. Posttraumatic growth and PTSD symptomatology among colorectal cancer survivors: a 3-month longitudinal examination of cognitive processing. Psychooncology. 2009 Jan;18(1):30-41. doi: 10.1002/pon.1367. — View Citation
Sans-Corrales M, Pujol-Ribera E, Gené-Badia J, Pasarín-Rua MI, Iglesias-Pérez B, Casajuana-Brunet J. Family medicine attributes related to satisfaction, health and costs. Fam Pract. 2006 Jun;23(3):308-16. Epub 2006 Feb 3. Review. — View Citation
Siqveland J, Nygaard E, Hussain A, Tedeschi RG, Heir T. Posttraumatic growth, depression and posttraumatic stress in relation to quality of life in tsunami survivors: a longitudinal study. Health Qual Life Outcomes. 2015 Feb 7;13:18. doi: 10.1186/s12955-014-0202-4. — View Citation
Sutin AR, Costa PT Jr, Wethington E, Eaton W. Perceptions of stressful life events as turning points are associated with self-rated health and psychological distress. Anxiety Stress Coping. 2010 Oct;23(5):479-92. doi: 10.1080/10615800903552015. — View Citation
Tedeschi RG, Calhoun LG. The Posttraumatic Growth Inventory: measuring the positive legacy of trauma. J Trauma Stress. 1996 Jul;9(3):455-71. — View Citation
Treynor, W., Gonzalez, R., & Nolen-Hoeksema, S. (2003). Rumination reconsidered: A psychometric analysis. Cognitive Therapy and Research, 27, 247-259.
Vazquez C, Blanco I, Sanchez A, McNally RJ. Attentional bias modification in depression through gaze contingencies and regulatory control using a new eye-tracking intervention paradigm: study protocol for a placebo-controlled trial. BMC Psychiatry. 2016 Dec 8;16(1):439. — View Citation
Vázquez, C. (2003). Técnicas cognitivas de intervención clínica. Madrid: Síntesios.
Vázquez, C., Castilla, C. & Hervás, G. (2009). Reacciones ante el trauma: Resistencia y crecimiento. En E. Fernández-Abascal (Ed.), Las Emociones Positivas (pp. 375-392). Madrid: Pirámide.
Wilson GT, Davison GC. Processes of fear reduction in systematic desensitization: animal studies. Psychol Bull. 1971 Jul;76(1):1-14. — View Citation
Wlodarczyk, A., Basabe, N., Páez, D., Amutio, A., García, F. E., Reyes, C., & Villagrán, L. (2016). Positive effects of communal coping in the aftermath of a collective trauma: The case of the 2010 Chilean earthquake. European Journal of Education and Psychology, 9(1), 9-19.
Wlodarczyk, A., Basabe, N., Páez, D., Villagrán, L., & Reyes, C. (2017). Individual and Collective Posttraumatic Growth in Victims of Natural Disasters: A Multidimensional Perspective. Journal of Loss and Trauma, 1-14.
Xu J, Song X. Posttraumatic stress disorder among survivors of the Wenchuan earthquake 1 year after: prevalence and risk factors. Compr Psychiatry. 2011 Jul-Aug;52(4):431-7. doi: 10.1016/j.comppsych.2010.08.002. Epub 2010 Sep 23. — View Citation
Zhou X, Wu X, Zhen R. Understanding the relationship between social support and posttraumatic stress disorder/posttraumatic growth among adolescents after Ya'an earthquake: The role of emotion regulation. Psychol Trauma. 2017 Mar;9(2):214-221. doi: 10.1037/tra0000213. Epub 2016 Oct 13. — View Citation
Zoellner T, Maercker A. Posttraumatic growth in clinical psychology - a critical review and introduction of a two component model. Clin Psychol Rev. 2006 Sep;26(5):626-53. Epub 2006 Mar 3. Review. — View Citation
* Note: There are 71 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Post-traumatic symptoms, pre-intervention evaluation | It will be measured with the brief post-traumatic stress disorder qualification interview (SPRINT-E scale) (Norris, Hamblen, Brown & Schinka, 2008), validated for the Chilean population by Leiva and Gallardo (2013), which has 14 items. Its minimum score is 0 and its maximum score is 36. A higher score means that the patient is worse, due to high post-traumatic symptoms. | Pre-intervention evaluation | |
Primary | Post-traumatic symptoms, post intervention evaluation | It will be measured with the brief post-traumatic stress disorder qualification interview (SPRINT-E scale) (Norris, Hamblen, Brown & Schinka, 2008), validated for the Chilean population by Leiva and Gallardo (2013), which has 14 items. Its minimum score is 0 and its maximum score is 36. A higher score means that the patient is worse, due to high post-traumatic symptoms. | Post-intervention evaluation, four weeks after the start of the intervention. | |
Primary | Post-traumatic symptoms, follow-up measure | It will be measured with the brief post-traumatic stress disorder qualification interview (SPRINT-E scale) (Norris, Hamblen, Brown & Schinka, 2008), validated for the Chilean population by Leiva and Gallardo (2013), which has 14 items. Its minimum score is 0 and its maximum score is 36. A higher score means that the patient is worse, due to high post-traumatic symptoms. | Follow-up measurement six months after the end of the intervention. | |
Secondary | Depressive symptomatology | To measure depressive symptoms, the Depression Scale of the Center for Epidemiological Studies will be used: Center for Epidemiological Studies - depression (CES-D; Radloff, 1977, translated by Gempp, Avendaño and Muñoz, 2004), which has 20 items. The lowest score is 0 and the highest is 60. A lower score means an improvement due to the fact that the patient has decreased depressive symptoms, while a higher score means that the patient feels worse due to the greater depressive symptoms. | A pre-intervention evaluation will be performed before starting the intervention, a post-intervention measurement four weeks later, and a follow-up measurement six months after the end of the intervention. | |
Secondary | Posttraumatic growth | To measure post-traumatic growth, the Post-traumatic Growth Inventory - Short Format Scale (PTGI-SF; Tedeschi and Calhoun, 1996), validated for Chile by García and Wlodarczyk (2015), which has 10 items, will be used. The lowest score is 0 and the highest is 50. A higher score means that the patient has experienced improvement due to increased post-traumatic growth. | A pre-intervention evaluation will be performed before starting the intervention, a post-intervention measurement four weeks later, and a follow-up measurement six months after the end of the intervention. | |
Secondary | Subjective well-being | It will be measured with the Life Satisfaction Scale (Diener, Emmos and Griffin, 1985), validated in Spanish by Moyano and Ramos (2007), which has 5 items. The lowest score is 5 and the highest is 35. A higher score means an improvement in the patient due to greater satisfaction with life. | A pre-intervention evaluation will be performed before starting the intervention, a post-intervention measurement four weeks later, and a follow-up measurement six months after the end of the intervention. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03384706 -
A Comparison of CPT Versus ART Versus WL
|
N/A | |
Completed |
NCT03418129 -
Neuromodulatory Treatments for Pain Management in TBI
|
N/A | |
Completed |
NCT03129204 -
Sensation Awareness Focused Training for Spouses
|
N/A | |
Recruiting |
NCT05651295 -
A Precision Medicine Approach to Target Engagement for Emotion Regulation
|
N/A | |
Completed |
NCT05113277 -
Development and Evaluation of a Tonic Immobility Focused Psychoeducational Intervention
|
N/A | |
Recruiting |
NCT05327504 -
Written Exposure Therapy for Veterans With SUD and PTSD
|
N/A | |
Recruiting |
NCT05843695 -
Enhancing Psychotherapy for Veterans and Service Members With PTSD and Anxiety
|
N/A | |
Active, not recruiting |
NCT05530642 -
An Augmented Training Program for Preventing Post-Traumatic Stress Injuries Among Diverse Public Safety Personnel
|
N/A | |
Completed |
NCT00644423 -
Omega-3 Fatty Acids and Post Traumatic Stress Disorder (PTSD)
|
N/A | |
Completed |
NCT02989987 -
NET for SGBV Survivors in Eastern DR Congo
|
N/A | |
Completed |
NCT02320799 -
Randomized Controlled Trial of Interpersonal Psychotherapy for Depression and PTSD Among HIV+ Women in Kenya
|
N/A | |
Recruiting |
NCT02293291 -
Thermal Clinic Treatment in Gulf War Illness
|
Phase 1/Phase 2 | |
Completed |
NCT02242136 -
Treatment of Posttraumatic Stress Disorder and Aggressive Behavior in Soldiers and Ex-combatants
|
N/A | |
Completed |
NCT02720497 -
The Efficacy of 90-Minute Versus 60-Minute Sessions of Prolonged Exposure for PTSD
|
N/A | |
Completed |
NCT01911585 -
Efficacy of 60-minute Versus 90-minute Sessions in Treating PTSD Using Prolonged Exposure
|
N/A | |
Terminated |
NCT01408641 -
Topiramate for Alcohol Use in Posttraumatic Stress Disorder
|
N/A | |
Completed |
NCT01693978 -
Contingency Outcomes in Prolonged Exposure
|
N/A | |
Completed |
NCT01469754 -
Longitudinal Survey Analysis in Lymphoma Survivors
|
N/A | |
Terminated |
NCT01239173 -
Emotional Memory Reactivation in Posttraumatic Stress Disorder
|
Phase 3 | |
Completed |
NCT02362477 -
Telemental Health and Cognitive Processing Therapy for Female Veterans With Military-related PTSD
|
Phase 3 |