CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 160 enrolled
Drug / intervention
Mindfulness +2 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04314115
NCT04314115N/ACompleted

Prevention of Mental Health Problems in People Exposed to a Recent Highly Stressful Event: a Randomized Controlled Study

Universidad Santo Tomas, Chile·interventional·Posted Mar 19, 2020·Updated Jan 24, 2022

In Brief

A clinical study evaluating Mindfulness, Systemic therapy, and 1 other intervention for Posttraumatic Stress Disorder and 2 related conditions. Completed, enrolled 160 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChile

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedMar 19, 2020
Enrollment StartApr 1, 2018
Primary CompletionMar 30, 2019
Study CompletionMar 30, 2021
TodayJul 2, 2026
Enrollment to primary: 12 monthsPosted 6.3 years ago

Interventions

Mindfulnessother

Brief intervention in mindfulness, of individual type, of four sessions of sixty minutes per week, in addition to individual tasks, according to protocol of brief intervention in developed mindfulness.

Systemic therapyother

Brief systemic therapy intervention, of four weekly sessions of sixty minutes, with individual tasks and assignments, according to the protocol designed.

Cognitive behavioral therapy and positive psychologyother

Brief intervention of traditional cognitive behavioral therapy with elements of positive psychology, of four weekly sessions of sixty minutes, with individual assignments and assignments, according to the protocol designed.