TF-CBT vs TST for Post-Traumatic Stress Disorder

Overseen By Yessenia Mejia

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: Intellectual disability, Active suicidality, others

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

Compensation: Varies

Number of Visits: 3

Duration: 3-4 months

237 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two therapies, Trauma Focused Cognitive Behavioral Therapy (TF-CBT) and Trauma Systems Therapy (TST), to assist children and teens who have experienced trauma and struggle with emotional regulation, such as PTSD. The goal is to evaluate the effectiveness of these treatments, particularly in addressing additional stress from racialized trauma and cultural adaptation. Children aged 5-17 who have faced trauma and have a parent or guardian willing to participate may be suitable candidates. As an unphased trial, this study provides a unique opportunity to enhance understanding and improve treatments for trauma in diverse populations.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

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

Research shows that both Trauma Focused Cognitive Behavioral Therapy (TF-CBT) and Trauma Systems Therapy (TST) are generally well-tolerated treatments for children with trauma.

Studies have found that TF-CBT consistently improves trauma symptoms. Children who have experienced various types of trauma usually respond well to this treatment. Reports from different studies highlight that TF-CBT not only reduces symptoms of post-traumatic stress disorder but also helps with depression and anxiety. No significant reports of negative effects exist, making it a safe option for many children.

Similarly, TST has shown positive results. Research indicates that most children continue with the treatment, suggesting they find it manageable. The therapy seems to reduce the need for hospital stays, implying it effectively improves mental health without causing harm.

Both therapies aim to support children through their trauma with minimal risks. Existing evidence points to their safety and effectiveness in helping children feel better. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for PTSD because they offer innovative approaches to therapy. Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) is unique because it combines traditional cognitive behavioral techniques with trauma-sensitive interventions, aiming to process trauma memories in a structured way. Trauma Systems Therapy (TST), on the other hand, focuses on addressing the broader systems surrounding an individual, like family and environmental factors, to support recovery. Unlike typical PTSD treatments that might focus solely on individual therapy, these approaches recognize the complex interplay of trauma and environment, offering more holistic options for healing.

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

Research has shown that Trauma Focused Cognitive Behavioral Therapy (TF-CBT), one of the treatments in this trial, effectively reduces symptoms of post-traumatic stress disorder (PTSD) in young people. Studies have found that TF-CBT significantly eases PTSD symptoms immediately after treatment and during follow-ups. Trauma Systems Therapy (TST), another treatment option in this trial, has also produced positive results. Specifically, participants in TST experienced notable decreases in PTSD symptoms, aggression, and even fewer hospital visits. Both therapies have successfully helped children and families cope with trauma and stress, offering hope for those considering these treatment options. ^{1 6 7 8 9}

Who Is on the Research Team?

Aaron Reliford

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for children and adolescents aged 5-17 who have experienced trauma leading to emotional issues like PTSD, along with a parent or guardian. They must be able to consent to the study. It's not for those at immediate risk of harm to self or others, or individuals with an intellectual disability (IQ<70).

Inclusion Criteria

I am a child/teen (5-17) with emotional issues due to trauma, and I have a parent/guardian.

I am able and willing to give my consent for treatment.

Exclusion Criteria

Individual with active suicidality, homicidality, or other symptoms at the time of enrollment that warrants hospitalization

My IQ is below 70, indicating an intellectual disability.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Baseline assessments including TSDS, SAFE, BAS, MEIM-6, and CATS scores are conducted

1 day

1 visit (in-person)

Treatment

Participants receive either Trauma Focused CBT (TF-CBT) or Trauma Systems Therapy (TST) for trauma intervention

3-4 months

Weekly sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments including TSDS, SAFE, BAS, MEIM-6, and CATS scores

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Trauma Focused CBT (TF-CBT)
• Trauma Systems therapy (TST)

Trial Overview The trial is testing Trauma Focused Cognitive Behavioral Therapy (TF-CBT) and Trauma Systems Therapy (TST) in treating trauma in kids. It aims to see how well these therapies work when considering additional stress from racial issues and adapting to new cultures.

How Is the Trial Designed?

Group I: Trauma Systems therapy (TST) Experimental Treatment 1 Intervention

Patients and families randomized to engage in TST.

Group II: Trauma Focused CBT (TF-CBT) Experimental Treatment 1 Intervention

Patients and families randomized to engage in TF-CBT.

Trauma Focused CBT (TF-CBT) is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Trauma-Focused Cognitive Behavioral Therapy for:

• Post-traumatic stress disorder (PTSD) in children and adolescents
• Trauma-related symptoms

Approved in European Union as Trauma-Focused Cognitive Behavioral Therapy for:

• Post-traumatic stress disorder (PTSD) in children and adolescents
• Trauma-related symptoms

Approved in Canada as Trauma-Focused Cognitive Behavioral Therapy for:

• Post-traumatic stress disorder (PTSD) in children and adolescents
• Trauma-related symptoms

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Substance Abuse and Mental Health Services Administration (SAMHSA)

Collaborator

Trials

31

Recruited

23,300+

Published Research Related to This Trial

Trauma-focused cognitive behavioral therapy (Tf-CBT) significantly reduced posttraumatic stress symptoms in children and adolescents compared to a waiting list control, as shown by a decrease in CAPS-CA scores over 4 months in a study involving 159 participants.

Younger patients and those with fewer comorbid disorders responded better to Tf-CBT, indicating that age and the presence of other mental health issues are important factors in treatment effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Trauma-Focused Cognitive Behavioral Therapy for Children and Adolescents: A Randomized Controlled Trial in Eight German Mental Health Clinics. Goldbeck, L., Muche, R., Sachser, C., et al.[2022]

A mobile phone-delivered serious game designed to enhance trauma-focused cognitive behavioral therapy (TF-CBT) for PTSD was found to be acceptable to both patients and clinicians, indicating potential for improved treatment engagement.

Both service users and clinicians suggested that the game should be therapist-guided and acknowledged that it may not be suitable for all patients, emphasizing the need for careful prescription by clinicians.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptability of a Plasticity-Focused Serious Game Intervention for Posttraumatic Stress Disorder: User Requirements Analysis. Jones, M., Denisova, A., Mitchell, S., et al.[2020]

Trauma-focused cognitive behavioral therapy (Tf-CBT) is an effective treatment for children and adolescents aged 3-17 with posttraumatic stress disorder (PTSD), supported by 13 randomized controlled trials and recognized as a first-line treatment in international guidelines.

Tf-CBT includes eight key components that help children process trauma and develop coping skills, making it a comprehensive approach that involves both the child and a supportive caregiver in the therapeutic process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Trauma-focused Cognitive-behavioral Therapy with children and adolescents: Practice, evidence base, and future directions]. Sachser, C., Rassenhofer, M., Goldbeck, L.[2018]

CAR-T therapy is recognized as a major breakthrough in cancer treatment, particularly for blood cancers, but it can lead to serious side effects like cytokine release syndrome (CRS) and neurotoxicity, which can be life-threatening.

The American Society for Transplantation and Cellular Therapy (ASTCT) has established a consensus grading system for assessing CRS and neurotoxicity, aiming to standardize evaluations across clinical trials and improve safety strategies in CAR-T therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Interpretation of ASTCT Consensus Responses by Chimeric Antigen Receptor T Cell Therapy CRS/ICANS--Review]. Fu, CC., Wang, RJ., Wu, DP.[2021]

CAR-T cell therapy, while a significant advancement in treating blood cancers, is associated with cardiotoxicity in both adults and pediatric patients, highlighting the need for careful monitoring of heart-related side effects.

The systematic review analyzed eight studies, emphasizing that various risk factors contribute to cardiac adverse events in patients undergoing CAR-T therapy, underscoring the importance of vigilance in patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiotoxicity Associated With Chimeric Antigen Receptor (CAR)-T Cell Therapy for Hematologic Malignancies: A Systematic Review. Hanna, KS., Kaur, H., Alazzeh, MS., et al.[2022]

Trauma-focused cognitive behavioral therapy (TF-CBT) is an effective family-centered treatment that involves both parents and traumatized children working together to address trauma responses.

Parental involvement in TF-CBT significantly boosts its effectiveness, helping children learn to manage their trauma-related thoughts and feelings more effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trauma-focused Cognitive Behavior Therapy for Traumatized Children and Families. Cohen, JA., Mannarino, AP.[2018]

Cognitive Processing Therapy (CPT) and Prolonged Exposure (PE) therapy have shown that 60-72% of patients still retain their PTSD diagnosis after treatment, highlighting a need for additional therapeutic options.

Accelerated Resolution Therapy (ART) may enhance existing trauma-focused therapies by focusing on rescripting traumatic events and providing a shorter intervention, showing positive outcomes in practice at Fort Belvoir Community Hospital.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Practice comparisons between accelerated resolution therapy, eye movement desensitization and reprocessing and cognitive processing therapy with case examples. Hernandez, DF., Waits, W., Calvio, L., et al.[2018]

Trauma-Focused Cognitive-Behavioral Therapy (TF-CBT) is a highly effective treatment for reducing posttraumatic stress symptoms in children, supported by high-level evidence from ten randomized controlled trials (RCTs).

While TF-CBT shows promise in addressing trauma-related symptoms, its effectiveness in reducing behavioral problems and depression symptoms remains less certain, highlighting the need for further research to optimize its application across diverse populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trauma-focused cognitive-behavioral therapy for children and adolescents: assessing the evidence. de Arellano, MA., Lyman, DR., Jobe-Shields, L., et al.[2022]

Trauma-focused cognitive behavioral therapy (TF-CBT) has been shown to be effective in treating trauma-related symptoms and improving psychosocial functioning in children and adolescents affected by conflict in low- and middle-income countries, based on a systematic review of 11 studies involving 1,354 participants.

Most studies were conducted in low-resource settings in East or Central Africa, where cultural adaptations were made to the TF-CBT delivery, highlighting the importance of tailoring interventions to meet local needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trauma-focused cognitive behavioral therapy for children and youth in low and middle-income countries: A systematic review. Thomas, FC., Puente-Duran, S., Mutschler, C., et al.[2022]

Adoptive cellular therapies, particularly CAR T cell therapies, have shown significant progress, with two therapies receiving regulatory approval in the U.S. in 2017, highlighting their potential in cancer treatment.

The effectiveness of these therapies is closely linked to their pharmacology and cellular kinetics post-infusion, but they also carry risks of unique toxicities such as cytokine release syndrome and neurotoxicity, which require further understanding.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Pharmacology of T Cell Therapies. Milone, MC., Bhoj, VG.[2020]

Adoptive cell therapy (ACT) has shown significant benefits in treating cancer, but it is associated with a range of toxicities, including cytokine release syndrome and neurological toxicity, which can be mild to life-threatening.

The review highlights the need for improved management strategies for these toxicities to enhance the safety of ACT treatments while maintaining their therapeutic effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The toxicity of cell therapy: Mechanism, manifestations, and challenges. Jin, Y., Dong, Y., Zhang, J., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11827035/

Effectiveness in routine care: trauma-focused treatment for ... Objective: The efficacy of trauma-focused cognitive behaviour therapy (tf-CBT) has been well established in randomized controlled trials (RCTs).

2. sciencedirect.com sciencedirect.com/science/article/pii/S0163834323001883

The efficacy and acceptability of group trauma-focused ... Group trauma-focused CBT significantly alleviates post-traumatic stress disorder symptoms in youth, demonstrating efficacy post-treatment and during follow-up.

3. psycnet.apa.org psycnet.apa.org/record/2026-17551-001

Efficacy of cognitive behavioral therapies with a trauma focus ... This individual participant data meta-analysis aimed to investigate the effectiveness of cognitive behavioral therapy with a trauma focus (CBT-TF) for ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4396183/

Trauma-Focused Cognitive Behavioral Therapy: Assessing ... TF-CBT has demonstrated positive outcomes in reducing symptoms of posttraumatic stress disorder, although it is less clear whether TF-CBT is effective in ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06516874

A Pilot Clinical Trial of Trauma-Focused Cognitive ... Randomized controlled trials have shown that trauma-focused cognitive behavioral therapy (TF-CBT) is effective in reducing PTSD symptoms; however, there is ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3116969/

Trauma-focused cognitive-behavioral therapy for ... This study examined the efficacy and feasibility of TF-CBT for treating PTSD in three through six year-old children exposed to heterogeneous types of traumas.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0145213422004331

A systematic review and meta-analysis of trauma-focused ... This meta-analysis quantified treatment effects of trauma-focused cognitive behavioral therapy (TF-CBT) with PTSS as primary outcome and symptoms of depression, ...

8. tandfonline.com tandfonline.com/doi/full/10.1080/10503307.2025.2469256

A mixed-methods evaluation of long-term outcomes after ... This study aimed to investigate long-term changes in trauma-related symptoms among children and youths who underwent TF-CBT due to family violence.

9. paloaltou.edu paloaltou.edu/resources/business-of-practice-blog/trauma-focused-cognitive-behavioral-therapy

Trauma-Focused Cognitive Behavioral Therapy Randomized clinical trials demonstrated that TF-CBT was superior for improving children's trauma symptoms and responses. TF-CBT addresses the multiple domains ...