180 Participants Needed

TF-CBT for Adolescent Post-Traumatic Stress Disorder

AG
AB
NG
Overseen ByNatalia Gomez-Giulilani
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: The University of Texas Health Science Center at San Antonio
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?

Posttraumatic stress disorder in adolescence impairs neurobiological networks underlying cognitive, social and emotional skills. Neuroimaging research that seeks to identify the neural mechanisms of treatments for PTSD could lead to novel treatments, but progress has been slow using current methods. The proposed study uses an innovative approach to identify neural mechanisms of specific phases of trauma-focused therapy for youth with PTSD, allowing a new understanding of brain changes associated with the process of therapy.

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 Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) safe for adolescents?

Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) is generally considered safe for children and adolescents with post-traumatic stress disorder (PTSD), as it has been widely studied and recommended as a first-line treatment in several international guidelines.12345

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

TF-CBT is unique because it specifically focuses on trauma and includes both the child and a supportive caregiver in the therapy process. It uses a structured approach with components like relaxation skills and trauma narrative, making it more effective than standard care in reducing PTSD symptoms in adolescents.12345

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

Research shows that Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) is effective for treating posttraumatic stress disorder (PTSD) in children and adolescents. Studies have found that TF-CBT significantly reduces PTSD symptoms, depression, and general mental health issues compared to standard care, and it is recommended as a first-line treatment for PTSD in young people.12345

Who Is on the Research Team?

AG

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.
See 8 more

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?
2Treatment groups
Experimental Treatment
Active Control
Group I: Trauma-focused cognitive behavioral therapy (TF-CBT)Experimental Treatment1 Intervention
Group II: Treatment As Usual (TAU)Active Control1 Intervention

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

🇺🇸
Approved in United States as Treatment as Usual for:
🇪🇺
Approved in European Union as Standard Care for:

Find a Clinic Near You

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

Citations

[Trauma-focused Cognitive-behavioral Therapy with children and adolescents: Practice, evidence base, and future directions]. [2018]
A randomized effectiveness study comparing trauma-focused cognitive behavioral therapy with therapy as usual for youth. [2022]
Does the therapist matter? Therapist characteristics and their relation to outcome in trauma-focused cognitive behavioral therapy for children and adolescents. [2022]
An intensive form of trauma focused cognitive behaviour therapy in an acute adolescent inpatient unit: An uncontrolled open trial. [2022]
Effectiveness of Trauma-Focused Cognitive Behavioral Therapy for Children and Adolescents: A Randomized Controlled Trial in Eight German Mental Health Clinics. [2022]
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