Prevention of Mental Health Problems in People Exposed to a Recent Highly Stressful Event.

NCT04314115 | Completed

• 1 other identifier: 1180134
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Posttraumatic Stress Disorder; Acute Post-Traumatic Stress Disorder; Depressive Symptoms

Keywords

Mindfulness; Brief systemic therapy; Cognitive Behavioral Therapy; Mental health; Prevention; Stressful events; Post-traumatic symptoms

Outcome Measures

Primary Outcomes (3)

• 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

• 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.

• 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 Outcomes (3)

• Depressive symptomatology

  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.

• Posttraumatic 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.

• Subjective well-being

  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.

Study Arms (4)

Mindfulness

ACTIVE COMPARATOR

A brief intervention in mindfulness will be administered

Other: Mindfulness

Systemic therapy

ACTIVE COMPARATOR

A brief systemic therapy intervention will be administered

Other: Systemic therapy

Cognitive behavioral therapy and positive psychology

ACTIVE COMPARATOR

A brief intervention of traditional cognitive behavioral therapy with positive psychology elements will be administered

Other: Cognitive behavioral therapy and positive psychology

Waiting list

NO INTERVENTION

Waiting list, as a control group

Interventions

Mindfulness OTHER

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.

Also known as: Brief intervention in mindfulness

Mindfulness

Systemic therapy OTHER

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

Also known as: Intervention in brief systemic therapy

Systemic therapy

Cognitive behavioral therapy and positive psychology OTHER

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.

Also known as: Brief intervention of traditional cognitive behavioral therapy and positive psychology

Cognitive behavioral therapy and positive psychology

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Santo Tomas, Chile: lead
• Universidad de Concepcion: collaborator

Study Sites (1)

Universidad Santo Tomas

Concepción, 4130000, Chile

Location

Related Publications (71)

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MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Depression; Psychological Well-Being

Interventions

Mindfulness; Crisis Intervention; Methods; Cognitive Behavioral Therapy; Psychology, Positive

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Personal Satisfaction

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Investigative Techniques; Psychology; Behavioral Sciences

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: March 9, 2020
• First Posted: March 19, 2020
• Study Start: April 1, 2018
• Primary Completion: March 30, 2019
• Study Completion: March 30, 2021
• Last Updated: January 24, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)