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NCT04314115
Prevention of Mental Health Problems in People Exposed to a Recent Highly Stressful Event.
NA trial testing Mindfulness in Posttraumatic Stress Disorder in 160 participants. Completed in 30 March 2021.
30 March 2019
Quick facts
| Lead sponsor | Universidad Santo Tomas, Chile |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | prevention |
| Enrollment | 160 |
| Start date | 1 April 2018 |
| Primary completion | 30 March 2019 |
| Estimated completion | 30 March 2021 |
| Sites | 1 location across Chile |
Drugs / interventions tested
- Mindfulness
- Systemic therapy — full drug profile →
- Cognitive behavioral therapy and positive psychology
Conditions studied
- Posttraumatic Stress Disorder — all drugs for Posttraumatic Stress Disorder →
- Acute Post-Traumatic Stress Disorder — all drugs for Acute Post-Traumatic Stress Disorder →
- Depressive Symptoms — all drugs for Depressive Symptoms →
Sponsor
Universidad Santo Tomas, Chile
Who can join
18 and older, any sex, with Posttraumatic Stress Disorder or Acute Post-Traumatic Stress Disorder. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04314115
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Mindfulness
Trials testing the same drug.
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- NCT07216417 — TeleYoga for Chronic Low Back Pain: A Quantitative and Qualitative Study · NA · active not recruiting
- NCT07346339 — Sensory Mindfulness for NICU Mothers: Effects on Breast Milk, Well-Being, and Stress · NA · completed
Other recruiting trials for Posttraumatic Stress Disorder
Currently open trials in the same condition.
- NCT04529031 — Biomolecular Characteristics of Reminder-Focused Positive-Psychiatry · NA · recruiting
- NCT06219408 — CIH Stepped Care for Co-occurring Chronic Pain and PTSD · NA · recruiting
- NCT07176273 — Adaptive Decision-making And Personalized Treatment for PTSD (ADAPT-PTSD) · NA · recruiting
- NCT07105345 — Exploring Efficacy of Multi-Mode Cognitive Processing Therapy (CPT) for PTSD · NA · recruiting
- NCT06608277 — Ketamine, SGB and Combination Treatment for TBI · Phase 2 · recruiting
Other Universidad Santo Tomas, Chile trials
Trials by the same sponsor.
- NCT07278141 — Effects of Resistance and Dual-Task Training on Physical, Oculomotor, and Executive Functions in Older Adults With MCI · NA · not yet recruiting
- NCT06482970 — Effectiveness of Exercise Plus Pain Neuroscience Education on Brain Function in Knee Osteoarthritis · NA · not yet recruiting
- NCT05953454 — Effectiveness of Pain Neuroscience Education on Clinical and Psychosocial Variables in Chronic Low Back Pain · NA · unknown
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04314115 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Universidad Santo Tomas, Chile
- Last refreshed: 24 January 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04314115.
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