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Mindfulness-Based Interventions + CCT for Traumatic Stress

N/A

Recruiting

Led By Victor Carrion, M.D.

Research Sponsored by Stanford University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Youth aged 11-17 with exposure to at least one DSM 5-defined traumatic event and meeting threshold criteria for posttraumatic symptoms per the UCLA PTSD scale.

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up three time points: baseline, week 8, week 23

Awards & highlights

Study Summary

This trial will assess the efficacy of mindfulness-based interventions and Cue-Centered Therapy (CCT) to improve mental wellbeing in Puerto Rico's educators & students who have experienced multiple disasters in the last 4 years.

Who is the study for?

This trial is for teachers and students in Puerto Rico's schools who are dealing with stress or burnout, especially those aged 11-17 with PTSD symptoms from recent traumatic events. Participants must be willing to undergo therapy, but can't join if they're already in trauma-focused treatment, have low IQ, substance dependence, serious medical issues, or autism/schizophrenia.Check my eligibility

What is being tested?

The study tests a mindfulness curriculum for educators and Cue-Centered Therapy (CCT) for students with PTSD. It aims to improve mental health after natural disasters and assesses genetic factors related to resilience by analyzing gene expression before and after the interventions.See study design

What are the potential side effects?

While not explicitly stated, potential side effects may include discomfort discussing traumatic experiences during CCT sessions or increased emotional sensitivity when engaging with mindfulness practices.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 11-17 years old and have PTSD symptoms from a traumatic event.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ three time points: baseline, week 8, week 23

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~three time points: baseline, week 8, week 23

This trial's timeline: 3 weeks for screening, Varies for treatment, and three time points: baseline, week 8, week 23 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Changes in Methylation Pattern of Genes

Mean Change from Baseline in Anxiety Score

Mean Change from Baseline in Depression Score

+3 more

Secondary outcome measures

Mean Change from Baseline in Family Functioning Score

Mean Change from Baseline in Sleep Quality Score

Trial Design

5Treatment groups

Experimental Treatment

Group I: iSWAB-DNAExperimental Treatment3 Interventions

Students that give prior consent to participating in DNA buccal swabs and the mindfulness curriculum are randomly selected to give buccal swabs prior to and after the mindfulness curriculum intervention. A subset of those students that qualify for CCT will give another buccal swab after CCT completion. DNA will be sent to Dr. Urban's lab for analysis of genetic resilience markers.

Group II: TeachersExperimental Treatment1 Intervention

Participants will be trained in the mindfulness curriculum and implement it in the classroom for 6-8 weeks. They will complete surveys before training and after implementation.

Group III: Mindfulness CurriculumExperimental Treatment1 Intervention

Participants will undergo a mindfulness curriculum in the classroom for 6-8 weeks and complete surveys before the start and after completion.

Group IV: CounselorsExperimental Treatment1 Intervention

Participants will be trained in Cue-Centered Therapy and implement the treatment with student clients for 15-18 weeks. They will complete surveys before training and after 3 months after the start of implementation.

Group V: CCTExperimental Treatment1 Intervention

Participants that report PTSD symptomatology during the mindfulness curriculum surveys will be eligible to participate in Cue-Centered Therapy treatment for 15-18 weeks. They will complete surveys before and after treatment.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Albizu UniversityUNKNOWN

University of IowaOTHER

447 Previous Clinical Trials

798,922 Total Patients Enrolled

Stanford UniversityLead Sponsor

2,395 Previous Clinical Trials

17,260,550 Total Patients Enrolled

Media Library

Cue Centered Therapy Counselors Clinical Trial Eligibility Overview. Trial Name: NCT05701111 — N/A

Post-Traumatic Stress Disorder Research Study Groups: Mindfulness Curriculum, Teachers, Counselors, CCT, iSWAB-DNA

Post-Traumatic Stress Disorder Clinical Trial 2023: Cue Centered Therapy Counselors Highlights & Side Effects. Trial Name: NCT05701111 — N/A

Cue Centered Therapy Counselors 2023 Treatment Timeline for Medical Study. Trial Name: NCT05701111 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this trial have age restrictions and are individuals aged 40+ permitted to participate?

"This clinical trial has established that the lower age limit for participants is 11 and the upper age boundary caps at 17 years old."

Answered by AI

Is eligibility open to join this clinical research endeavor?

"This trial requires applicants to have PTSD and be between the ages of 11-17, with a total maximum enrollment of 80,800 individuals."

Answered by AI

Are individuals still being accepted to participate in this experiment?

"The clinical trial's information on clinicaltrials.gov reveals that no more volunteers are being sought at this time, as it was initially listed in March 1st 2023 and last updated on January 24th 2023. However, there is a range of other options available with 1406 medical studies now recruiting participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Building Resilience at Schools: Emotional and Biological Assessment and Treatment of Traumatic Stress

Victor Carrion 2024. "Building Resilience at Schools: Emotional and Biological Assessment and Treatment of Traumatic Stress". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05701111.