TF-CBT for Adolescent Post-Traumatic Stress Disorder

Overseen By Natalia Gomez-Giulilani

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center at San Antonio

Must not be taking: Psychiatric medications

Disqualifiers: Suicidal ideation, Psychosis, Bipolar, Autism, others

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

Compensation: Varies

Number of Visits: 18

180 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how trauma-focused cognitive behavioral therapy (TF-CBT) affects the brains of teens with post-traumatic stress disorder (PTSD). Researchers seek to observe how this therapy, which includes steps like learning about trauma, managing emotions, and creating a safety plan, alters brain function. The trial will compare TF-CBT with usual therapy methods (TAU) over 18 weeks. Teens aged 12-17 who have experienced trauma and have ongoing PTSD symptoms might be suitable candidates.

As an unphased trial, this study offers a unique opportunity for teens to contribute to important research that could enhance PTSD treatments.

Will I have to stop taking my current medications?

The trial does not allow participants who are currently using psychiatric medications, so you would need to stop taking them to join.

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

Research has shown that Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) is a safe and effective treatment for trauma in young people. Studies have found that TF-CBT reduces trauma-related symptoms and is well-tolerated by children and teens. Clinical trials demonstrated that TF-CBT outperforms other therapies in improving symptoms for young people who have experienced trauma. These studies reported no major safety issues, making TF-CBT a strong option for those considering treatment for post-traumatic stress disorder (PTSD). ^{1 2 3 4 5}

Why are researchers excited about this trial?

Trauma-focused cognitive behavioral therapy (TF-CBT) is unique because it provides a structured and evidence-based approach specifically designed for treating trauma in adolescents. Unlike standard treatments that may vary widely in techniques and order, TF-CBT follows a specific sequence of phases, including psychoeducation, emotion regulation, processing the trauma narrative, and safety planning. This structured method aims to directly address the trauma and equip young individuals with essential coping skills, making it a gold-standard option for effectively treating post-traumatic stress disorder in youth. Researchers are excited about TF-CBT because of its flexibility and proven effectiveness in helping adolescents overcome trauma-related challenges.

What is the effectiveness track record for Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) in treating adolescent PTSD?

Research has shown that Trauma-Focused Cognitive Behavioral Therapy (TF-CBT), one of the treatments studied in this trial, effectively treats post-traumatic stress disorder (PTSD) in young people. Studies have found that TF-CBT not only reduces PTSD symptoms but also alleviates depression, anxiety, and grief. It is considered superior to other treatments. Additionally, TF-CBT has proven effective in regular mental health clinics, not just in research settings. Experts regard TF-CBT as the top treatment choice for PTSD in children and teens, regardless of age, gender, or type of trauma. Therefore, strong evidence supports the use of TF-CBT for adolescents with PTSD. ^{3 6 7 8 9}

Who Is on the Research Team?

Amy Garrett, PhD

Principal Investigator

University of Texas Health Science Center San Antonio

Are You a Good Fit for This Trial?

This trial is for adolescents aged 12-17 with PTSD from interpersonal trauma, who have not had prior TF-CBT treatment or other current psychotherapy. They must be at a certain stage of physical development (Tanner stage 2+), and have specific PTSD symptoms lasting over a month. Those with severe suicidal thoughts, low IQ, MRI contraindications like metal in the body, family history of psychosis or bipolar I disorder, significant head injury, major medical illness or recent substance dependence can't join.

Inclusion Criteria

I am between 12 and 17 years old and have started puberty.

I have PTSD symptoms in all 4 clusters for over a month.

History of interpersonal trauma

Exclusion Criteria

Severe suicidal/homicidal ideation

I am currently in the hospital.

I am currently in psychotherapy or have had TF-CBT before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Skills Phase

Participants undergo the skills phase of TF-CBT, focusing on psychoeducation and emotion regulation skills

6 weeks

6 visits (in-person)

Narrative Phase

Participants process the trauma narrative during this phase of TF-CBT

6 weeks

6 visits (in-person)

Consolidation Phase

Participants engage in safety planning and consolidate skills learned during TF-CBT

6 weeks

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• TAU
• TF-CBT

Trial Overview

The study is testing how effective Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) is compared to Treatment as Usual (TAU) in improving neural connectivity related to cognitive, social and emotional skills in teens with PTSD. It uses neuroimaging to track brain changes during therapy phases.

How Is the Trial Designed?

Group I: Trauma-focused cognitive behavioral therapy (TF-CBT) Experimental Treatment 1 Intervention

Trauma-focused Cognitive Behavioral Therapy (TF-CBT) is an evidence-based psychotherapy that is considered the gold-standard treatment for trauma in youth. The TF-CBT model is flexible but it follows a specific order of phases and components, including psychoeducation, emotion regulation skills, processing the trauma narrative, and safety planning. Sessions are provided weekly for 18-weeks.

Group II: Treatment As Usual (TAU) Active Control 1 Intervention

Treatment as usual (TAU) consists of the standard-of-care psychotherapy as provided by licensed clinicians at a local clinic. The order and choice of techniques is based on the knowledge and preferences of the clinicians. Sessions are provided weekly for 18-weeks.

TAU is already approved in United States, European Union for the following indications:

Approved in United States as Treatment as Usual for:

• General psychiatric care
• Residential treatment follow-up

Approved in European Union as Standard Care for:

• Psychiatric residential treatment
• Post-treatment support

Who Is Running the Clinical Trial?

The University of Texas Health Science Center at San Antonio

Lead Sponsor

Trials

486

Recruited

92,500+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

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]

In a study involving 52 therapists and 153 traumatized children and adolescents, therapist characteristics such as gender, clinical experience, and theoretical background did not significantly impact the effectiveness of Trauma-Focused Cognitive-Behavioral Therapy (TF-CBT) in reducing posttraumatic stress symptoms (PTSS).

The findings suggest that TF-CBT could be effectively disseminated more widely, as the lack of influence from therapist characteristics indicates that training and supervision in TF-CBT may be more critical than individual therapist traits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does the therapist matter? Therapist characteristics and their relation to outcome in trauma-focused cognitive behavioral therapy for children and adolescents. Pfeiffer, E., Ormhaug, SM., Tutus, D., et al.[2022]

An intensive form of trauma-focused cognitive behavior therapy (TF-CBT) was implemented for 15 adolescents with PTSD in an inpatient unit, showing significant improvements in PTSD symptoms and overall functioning after an average of nine sessions over 28 days.

The average PTSD symptom score decreased from 23.73 to 8.27, and the global functioning score improved from 19 to 48.7, indicating that TF-CBT can be effective in treating PTSD in hospitalized adolescents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An intensive form of trauma focused cognitive behaviour therapy in an acute adolescent inpatient unit: An uncontrolled open trial. Cabrera, N., Moffitt, G., Jairam, R., et al.[2022]

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) significantly reduced posttraumatic stress symptoms, depression, and general mental health issues in 156 traumatized youth compared to those receiving therapy as usual (TAU).

TF-CBT also led to greater improvements in functional impairment and resulted in fewer diagnoses of posttraumatic stress disorder among participants, indicating its effectiveness in community mental health settings and potential for use outside the United States.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized effectiveness study comparing trauma-focused cognitive behavioral therapy with therapy as usual for youth. Jensen, TK., Holt, T., Ormhaug, SM., et al.[2022]

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/36155943/

A systematic review and meta-analysis of trauma-focused ...

TF-CBT is an effective treatment for pediatric PTSS as well as for depressive, anxiety, and grief symptoms. It is superior to control conditions.

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4037845/

A Randomized Effectiveness Study Comparing Trauma ...

Findings indicate that TF-CBT is effective in treating traumatized youth in community mental health clinics and that the program may also be successfully ...

3.

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.

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07052474

Intensive Trauma-Focused Treatment for Adolescents With ...

According to NICE treatment guidelines, the two primary recommended treatments for PTSD in children and adolescents are Trauma-Focused Cognitive ...

5.

sciencedirect.com

sciencedirect.com/science/article/pii/S2352464223002535

Efficacy and moderators of efficacy of cognitive behavioural ...

Our findings support CBTs-TF as the first-line treatment, irrespective of age, gender, trauma characteristics, or carer involvement in treatment.

6.

pmc.ncbi.nlm.nih.gov

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

Trauma-Focused Cognitive Behavioral Therapy: Assessing ...

TF-CBT is a viable treatment for reducing trauma-related symptoms among some children who have experienced trauma and their nonoffending caregivers.

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.

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 ...

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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.