Prevention of Mental Health Problems in People Exposed to a Recent Highly Stressful Event.
- Sponsor
- Universidad Santo Tomas, Chile
- Study ID
- NCT04314115
- Status
- Completed
Conditions
- Acute Post-Traumatic Stress Disorder
- Depressive Symptoms
- Posttraumatic Stress Disorder
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Accepted
Interventions
- Mindfulness — OTHERBrief 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 therapy — OTHERBrief 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 psychology — OTHERBrief 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.
Study Details
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.
Key Dates
- Start date
- Apr 1, 2018
- Status verified
- Jan 2022
- Primary completion
- Mar 30, 2019
- Completion
- Mar 30, 2021
Study Design
- Enrollment
- 160 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- PREVENTION
Arms
- Active Comparator: MindfulnessA brief intervention in mindfulness will be administered
- Active Comparator: Systemic therapyA brief systemic therapy intervention will be administered
- Active Comparator: Cognitive behavioral therapy and positive psychologyA brief intervention of traditional cognitive behavioral therapy with positive psychology elements will be administered
- No Intervention: Waiting listWaiting list, as a control group
Primary Outcome Measure
Post-traumatic symptoms, pre-intervention evaluation [ Time Frame: Pre-intervention evaluation ]
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