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

Trial Summary

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.

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. ^{1 2 3 4 5}

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. ^{1 2 3 4 5}

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. ^{1 2 3 4 5}

Research Team

Amy Garrett, PhD

Principal Investigator

University of Texas Health Science Center San Antonio

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

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

2. England pubmed.ncbi.nlm.nih.gov

A randomized effectiveness study comparing trauma-focused cognitive behavioral therapy with therapy as usual for youth. [2022]

3. United States 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. [2022]

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

An intensive form of trauma focused cognitive behaviour therapy in an acute adolescent inpatient unit: An uncontrolled open trial. [2022]

5. 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]