80800 Participants Needed

Mindfulness-Based Interventions + CCT for Traumatic Stress

Recruiting at 2 trial locations
EL
EL
Overseen ByElizabeth Lab Administrator
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: Stanford University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

In the last four years alone, residents of Puerto Rico have experienced a slew of natural disasters including Hurricane Maria in 2017, earthquakes in 2019 and 2020, the continued COVID-19 pandemic from 2020-2022, and most recently Hurricane Fiona. This series of distressing events can lead to an increased need for mental health resources and trauma treatment. Furthermore, the unique single-district structure of the Puerto Rican education system allows for the efficient dissemination of potential interventions and treatment to all students.The purpose of this study is to examine two treatment conditions for educators and school-aged children in Puerto Rico experiencing burnout, fatigue, and high stress: delivery of a mindfulness-based educator curriculum and, for children who report Post Traumatic Stress Disorder (PTSD) symptomatology, delivery of the mindfulness curriculum with the additional intervention of Cue-Centered Therapy (CCT). The study has two aims: 1) To assess the efficacy of the mindfulness curriculum and of CCT in a population of students, counselors, and teachers, characterized by high stress over the last few years of natural disasters and pandemic challenges and 2) To identify genetic contributions to resilience by analyzing gene expression in students before and after the intervention.The overarching goals of the investigators' research collaboration are to improve educators' psychological well-being and children's socioemotional development when faced with high stress and adversity and to improve mental health clinicians' competence and confidence in treating children exposed to trauma by training them in CCT. The investigators' research will identify critical biopsychosocial components responsible for the cognitive, behavioral, and emotional improvement and effective implementation strategies in a large but geographically dispersed school district. The knowledge base that will result from this study will inform the implementation of trauma-informed care in school settings and with populations experiencing stress and adversity, and contribute to the investigators' understanding of the underlying biology of these interventions to provide a rationale for further development and dissemination.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have a clinically significant medical illness or substance dependence, you may not be eligible to participate.

Is Cue-Centered Therapy (CCT) safe for treating traumatic stress in humans?

Research on Cue-Centered Therapy (CCT) for youth exposed to trauma shows it is feasible and effective, with no specific safety concerns reported in the studies. It has been used successfully in school settings for children who have experienced violence, suggesting it is generally safe for this population.12345

How is the Mindfulness-Based Interventions + CCT treatment for traumatic stress different from other treatments?

This treatment is unique because it combines mindfulness-based techniques with Cue-Centered Therapy (CCT), which is specifically designed to address complex developmental trauma by integrating neuroscience principles and client empowerment. Unlike other treatments, it offers a flexible and insight-oriented approach to reduce posttraumatic stress, depression, and anxiety, particularly in children exposed to violence.12367

What data supports the effectiveness of the treatment Mindfulness-Based Interventions + CCT for Traumatic Stress?

Research shows that Cue-Centered Therapy (CCT) is effective in reducing symptoms of posttraumatic stress, depression, and anxiety in children exposed to violence. This therapy combines different approaches to help children understand and manage their trauma, making it a promising option for treating traumatic stress.12489

Who Is on the Research Team?

AU

Alexander Urban, Ph.D.

Principal Investigator

Associate Professor

VC

Victor Carrion, M.D.

Principal Investigator

John A. Turner, M.D. Professor and Vice-Chair of Psychiatry and Behavioral Sciences at Stanford University and Director of the Stanford Early Life Stress and Resilience Program

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am between 11-17 years old and have PTSD symptoms from a traumatic event.
Caregiver willing to participate in therapy
Adults and students/caregivers willing to participate in the study
See 3 more

Exclusion Criteria

I have a serious health condition.
You are currently receiving therapy from a mental health professional for trauma-related issues.
Substance dependence as defined by DSM criteria
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Mindfulness Curriculum

Participants undergo a mindfulness curriculum in the classroom for 6-8 weeks and complete surveys before and after the intervention

6-8 weeks
2 visits (in-person)

Cue-Centered Therapy (CCT)

Participants with PTSD symptomatology receive Cue-Centered Therapy treatment for 15-18 weeks

15-18 weeks
3 visits (in-person)

Follow-up

Participants are monitored for changes in anxiety, depression, and other psychological measures after treatment

15 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Cue Centered Therapy Counselors
  • Cue Centered Therapy Students
  • iSWAB-DNA
  • Start with the Heart Students
  • Start with the Heart Teachers
Trial Overview 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.
How Is the Trial Designed?
5Treatment groups
Experimental Treatment
Group I: iSWAB-DNAExperimental Treatment3 Interventions
Group II: TeachersExperimental Treatment1 Intervention
Group III: Mindfulness CurriculumExperimental Treatment1 Intervention
Group IV: CounselorsExperimental Treatment1 Intervention
Group V: CCTExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials
2,527
Recruited
17,430,000+

Albizu University

Collaborator

Trials
1
Recruited
80,800+

University of Iowa

Collaborator

Trials
486
Recruited
934,000+

Ponce Health Sciences University

Collaborator

Trials
3
Recruited
82,900+

Pure Edge Inc.

Collaborator

Trials
2
Recruited
82,000+

Iowa State University

Collaborator

Trials
63
Recruited
145,000+

Ponce Health Sciences University

Collaborator

Trials
2
Recruited
80,900+

Published Research Related to This Trial

Stanford's cue-centered therapy (CCT) shows promising effectiveness in reducing posttraumatic stress in children and caregivers, while also improving child functioning, indicating its potential as a valuable intervention for complex developmental trauma.
Further research is necessary to determine which specific clients benefit most from CCT and to identify the key components of the therapy that are most effective in addressing complex developmental trauma.
Cue-Centered Therapy for Youth Experiencing Posttraumatic Symptoms.Kletter, H., Matlow, R., Tanovic, S., et al.[2022]
The Stanford cue-centered treatment was found to be effective in reducing PTSD symptoms, anxiety, and depression in children aged 8-17 who have been exposed to violence, based on a study involving 65 participants.
Compared to a waitlist control group, those receiving cue-centered treatment showed significant improvements in PTSD symptoms as reported by both caregivers and children, indicating the treatment's feasibility and adherence in a school setting.
Cue-centered treatment for youth exposed to interpersonal violence: a randomized controlled trial.Carrion, VG., Kletter, H., Weems, CF., et al.[2019]
The Core Curriculum on Childhood Trauma (CCCT) training has shown significant retention of trauma-related skills among over 100 mental health practitioners, with effect sizes ranging from 0.90 to 1.07 measured 6-24 months after training.
Participants reported key improvements in clinical practice, including increased empathy and a better understanding of trauma complexity, indicating that the CCCT effectively enhances trauma-informed care in mental health settings.
How do we get to trauma-informed practice? Retention and application of learning by practitioners trained using the core curriculum on childhood trauma.Dublin, S., Abramovitz, R., Katz, L., et al.[2021]

Citations

Cue-Centered Therapy for Youth Experiencing Posttraumatic Symptoms. [2022]
Cue-centered treatment for youth exposed to interpersonal violence: a randomized controlled trial. [2019]
How do we get to trauma-informed practice? Retention and application of learning by practitioners trained using the core curriculum on childhood trauma. [2021]
Treatment manual for trauma-exposed youth: case studies. [2015]
Feasibility, acceptability, and effectiveness of web-based and mobile PTSD Coach: a systematic review and meta-analysis. [2023]
The evidence for present-centered therapy as a treatment for posttraumatic stress disorder. [2022]
Web-Based Training for an Evidence-Supported Treatment: Training Completion and Knowledge Acquisition in a Global Sample of Learners. [2019]
Control-Focused Behavioral Treatment: A brief intervention for survivors of war and torture. [2022]
A pilot study of group mindfulness-based cognitive therapy (MBCT) for combat veterans with posttraumatic stress disorder (PTSD). [2022]
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