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

475 Participants Needed

Trial Summary

What is the purpose of this trial?

Investigators plan to offer two evidence based interventions - Trauma Focused Cognitive Behavioral Therapy (CBT) (TF-CBT) and Trauma Systems therapy (TST) to traumatized children and their families. The investigators are looking to evaluate the effectiveness of these interventions in the context of additional stress related to racialized trauma and acculturation stress

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment TF-CBT for Post-Traumatic Stress Disorder?

Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) is well-supported as an effective treatment for children and adolescents with posttraumatic stress symptoms, and it is considered a gold standard treatment for childhood PTSD in Western countries. It involves both the child and their parents, helping them manage trauma responses and improve emotional regulation. ^{1 2 3 4 5}

Is Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) or Trauma Systems Therapy (TST) safe for treating PTSD?

The provided research articles do not contain specific safety information about Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) or Trauma Systems Therapy (TST) for PTSD or other conditions. ^{6 7 8 9 10}

How is TF-CBT different from other treatments for PTSD?

TF-CBT is unique because it combines cognitive-behavioral principles with exposure techniques and involves both the child and a supportive caregiver in the therapy process. It is structured around eight components, summarized by the acronym P.R.A.C.T.I.C.E, and is considered a first-line treatment for children and adolescents with PTSD. ^{1 2 3 4 11}

Research Team

Aaron Reliford

Principal Investigator

NYU Langone Health

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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) 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]

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]

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]

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]

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]

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]

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 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]

References

1. Canada pubmed.ncbi.nlm.nih.gov

Acceptability of a Plasticity-Focused Serious Game Intervention for Posttraumatic Stress Disorder: User Requirements Analysis. [2020]

2. Switzerland 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. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Trauma-focused cognitive-behavioral therapy for children and adolescents: assessing the evidence. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Trauma-focused cognitive behavioral therapy for children and youth in low and middle-income countries: A systematic review. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Trauma-focused Cognitive Behavior Therapy for Traumatized Children and Families. [2018]

6. China pubmed.ncbi.nlm.nih.gov

[Interpretation of ASTCT Consensus Responses by Chimeric Antigen Receptor T Cell Therapy CRS/ICANS--Review]. [2021]

7. Scotland pubmed.ncbi.nlm.nih.gov

Practice comparisons between accelerated resolution therapy, eye movement desensitization and reprocessing and cognitive processing therapy with case examples. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

The Pharmacology of T Cell Therapies. [2020]

9. England pubmed.ncbi.nlm.nih.gov

The toxicity of cell therapy: Mechanism, manifestations, and challenges. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Cardiotoxicity Associated With Chimeric Antigen Receptor (CAR)-T Cell Therapy for Hematologic Malignancies: A Systematic Review. [2022]

11. Switzerland pubmed.ncbi.nlm.nih.gov

[Trauma-focused Cognitive-behavioral Therapy with children and adolescents: Practice, evidence base, and future directions]. [2018]