Mindfulness-Based Interventions + CCT for Traumatic Stress

Recruiting at 2 trial locations

Overseen By Lab Adminstrator

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Current trauma therapy, Low IQ, Substance dependence, Autism, Schizophrenia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

80800 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help teachers and students in Puerto Rico manage stress and trauma from recent natural disasters and the COVID-19 pandemic. It tests two approaches: a mindfulness curriculum for educators and students, and Cue-Centered Therapy (CCT) for students showing PTSD symptoms. The study will explore how these treatments can improve mental health and identify genetic factors linked to resilience. Suitable candidates for this trial include teachers and students feeling overwhelmed or stressed from past events, and students aged 11-17 who have experienced trauma and show PTSD symptoms. As an unphased trial, this study offers participants the chance to contribute to innovative mental health solutions and access potentially beneficial treatments.

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 there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that mindfulness-based activities are generally easy for people to handle. Many teachers find these techniques helpful for managing stress and burnout. For example, a special version of a Mindfulness-Based Stress Reduction course, tailored for teachers, showed positive results without major side effects. This suggests that mindfulness practices can be a safe option for both teachers and students seeking stress relief.

Cue-Centered Therapy (CCT) is also known to be safe. It has been successfully used with children and teens who have experienced trauma. Research shows that CCT is practical and can help reduce posttraumatic stress without significant negative effects. Specifically designed for young people dealing with ongoing stress and trauma, it is a good choice for school-aged children who need support.

Overall, both mindfulness-based activities and CCT have proven safe and effective for managing stress and trauma in schools. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these mindfulness-based interventions combined with Cue-Centered Therapy (CCT) for traumatic stress because they offer a unique, holistic approach to healing. Unlike standard treatments that often rely on medication or traditional talk therapy, this approach incorporates mindfulness practices and CCT, which focus on understanding and managing the body's response to trauma cues. This dual focus not only addresses the psychological aspects of traumatic stress but also promotes resilience by potentially altering genetic markers linked to stress response. Additionally, by training teachers and counselors, this approach can be seamlessly integrated into educational settings, making it accessible and sustainable for young people coping with traumatic stress.

What evidence suggests that this trial's treatments could be effective for traumatic stress?

Research shows that mindfulness activities in schools can help both teachers and students feel better and less stressed. In this trial, participants in the "Mindfulness Curriculum" and "Teachers" arms will engage in these activities. Studies have found that these activities improve self-care and social interactions, making stress easier to manage.

For Cue-Centered Therapy (CCT), which participants in the "Counselors" and "CCT" arms will undergo, evidence indicates it reduces PTSD symptoms, anxiety, and depression in children who have faced trauma. CCT directly addresses trauma-related stress, leading to better overall functioning. These methods offer promising ways to improve mental health for those dealing with high stress and trauma in schools. ^{1 3 6 7 8}

Who Is on the Research Team?

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

Alexander Urban, Ph.D.

Principal Investigator

Associate Professor

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

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

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?

Group I: iSWAB-DNA Experimental Treatment 3 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: Teachers Experimental Treatment 1 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 Curriculum Experimental Treatment 1 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: Counselors Experimental Treatment 1 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: CCT Experimental Treatment 1 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.

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

The Stanford Cue-Centered Therapy (CCT) is a new, short-term psychotherapy designed for children who have experienced trauma, focusing on helping them cope with trauma-related cues.

Two case studies from a middle school in an inner-city neighborhood suggest that CCT is feasible and effective for high-risk youth, highlighting the potential for training school mental health personnel to implement this therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment manual for trauma-exposed youth: case studies. Carrion, VG., Hull, K.[2015]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cue-centered treatment for youth exposed to interpersonal violence: a randomized controlled trial. Carrion, VG., Kletter, H., Weems, CF., et al.[2019]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cue-Centered Therapy for Youth Experiencing Posttraumatic Symptoms. Kletter, H., Matlow, R., Tanovic, S., et al.[2022]

Present-centered therapy (PCT) has been shown to be as effective as existing evidence-based treatments for PTSD in 3 out of 5 randomized clinical trials, with large effect sizes in cases where no treatment was provided.

PCT also had a significantly lower dropout rate (14.3%) compared to other treatments (31.3%), indicating it may be a more acceptable option for patients with PTSD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The evidence for present-centered therapy as a treatment for posttraumatic stress disorder. Frost, ND., Laska, KM., Wampold, BE.[2022]

A total of 123,848 learners registered for the TF-CBTWeb training program, with 68.1% completing the full course, indicating high engagement and feasibility of web-based training for Trauma-Focused Cognitive Behavioral Therapy (TF-CBT).

Participants showed significant increases in knowledge about TF-CBT, as evidenced by improved scores from pretests to posttests, highlighting the effectiveness of this training method in enhancing understanding of trauma treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Web-Based Training for an Evidence-Supported Treatment: Training Completion and Knowledge Acquisition in a Global Sample of Learners. Heck, NC., Saunders, BE., Smith, DW.[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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Control-Focused Behavioral Treatment (CFBT) is a unique self-help approach that focuses on reducing avoidance behaviors related to trauma, achieving an impressive 80%-85% improvement rate after just one session for earthquake survivors.

In war and torture survivors, CFBT led to an 82% reduction in PTSD symptoms over an average of 6 sessions, with 97% of participants becoming nearly asymptomatic, indicating its efficacy compared to other treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Control-Focused Behavioral Treatment: A brief intervention for survivors of war and torture. Başoğlu, M.[2022]

Mindfulness-based cognitive therapy (MBCT) adapted for combat PTSD showed significant improvement in PTSD symptoms compared to treatment-as-usual, with a notable reduction in avoidance symptoms and PTSD-related negative cognitions.

The study involved 37 participants (20 in the MBCT group and 17 in the TAU group) over an 8-week period, and 75% of MBCT completers demonstrated good compliance and clinically meaningful improvements in their PTSD assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot study of group mindfulness-based cognitive therapy (MBCT) for combat veterans with posttraumatic stress disorder (PTSD). King, AP., Erickson, TM., Giardino, ND., et al.[2022]

The 'PTSD Coach' intervention, available as both a web-based and mobile application, is feasible and generally well-accepted among trauma-exposed individuals, with high satisfaction reported in most studies.

However, the effectiveness of the 'PTSD Coach' in significantly reducing posttraumatic stress symptoms (PTSS) remains unclear, as the pooled effect size was not statistically significant, indicating a need for further research, especially in low-middle-income countries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility, acceptability, and effectiveness of web-based and mobile PTSD Coach: a systematic review and meta-analysis. Bröcker, E., Suliman, S., Olff, M., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8054844/

Cue-Centered Therapy for Youth Experiencing Posttraumatic ... Results found reduced child symptoms of PTSD (both by child and caregiver reports), anxiety, and depression as well as overall improvement in functioning.

2. med.stanford.edu med.stanford.edu/elspap/Cue-Centered-Therapy/news.html

CCT Press and Publications - Stanford Medicine To date, two RCTs studying CCT have been completed. These studies demonstrate CCT effectiveness in reducing child and caregiver posttraumatic stress and in ...

3. med.stanford.edu med.stanford.edu/content/dam/sm/elspap/documents/A50.pdf

Cue-Centered Treatment for Youth Exposed to Interpersonal ... This study provides preliminary evidence of the feasibility and efficacy of the Stanford cue-centered treatment for reducing posttraumatic stress ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0022395622005453

Cortical activation predicts posttraumatic improvement in ... Overall, PTSD symptoms decreased from pre-intervention through follow-up across conditions, with some evidence of relative benefit of TF-CBT and CCT over TAU ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33898161/

Cue-Centered Therapy for Youth Experiencing ... Recent findings: Studies demonstrate promising outcomes indicating CCT effectiveness in reducing child and caregiver posttraumatic stress, and ...

6. cebc4cw.org cebc4cw.org/program/cue-centered-therapy-cct/

CEBC » Program › Cue Centered Therapy Cct About This Program ; Target Population: Youth ages 8-18 with a chronic history of trauma, adversity, and ongoing stress ; For children/adolescents ages: 8 – 18.

7. sciencedirect.com sciencedirect.com/science/article/pii/S2666915322000737

Beyond fear: Patients with posttraumatic stress disorder fail ... In the present study, we showed that patients with PTSD failed to engage in safety cues and also presented lower levels of trait positive affect and optimism.

8. med.stanford.edu med.stanford.edu/elspap/Cue-Centered-Therapy.html

Cue-Centered Therapy - Stanford Medicine Cue-Centered Therapy, or CCT, is an evidence-based intervention for youth with chronic traumatic experiences.