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,
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* 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. |
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