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TF-CBT for Adolescent Post-Traumatic Stress Disorder

N/A
Recruiting
Led By Amy Garrett, PhD
Research Sponsored by The University of Texas Health Science Center at San Antonio
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Ages 12-17 and Tanner stage 2 or above
PTSD symptoms with a rating of '2' or higher on at least one symptom from each of the 4 clusters, using the Clinician-Administered PTSD Scale for Children and Adolescents, and having a duration of at least one month
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 18
Awards & highlights

Study Summary

This trialseeks to develop new treatments for PTSD in adolescents by using innovative brain scanning to understand how therapy helps.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While the trial focuses on therapy rather than medication and may not involve typical drug side effects, participating adolescents might experience emotional discomfort when discussing traumatic events during sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 12 and 17 years old and have started puberty.
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I have PTSD symptoms in all 4 clusters for over a month.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 18
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 18 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean intensity within functional connectivity map of intrinsic network

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Trauma-focused cognitive behavioral therapy (TF-CBT)Experimental Treatment1 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 Control1 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TF-CBT
2011
Completed Phase 2
~2200

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center at San AntonioLead Sponsor
452 Previous Clinical Trials
91,248 Total Patients Enrolled
National Institute of Mental Health (NIMH)NIH
2,777 Previous Clinical Trials
2,674,192 Total Patients Enrolled
Amy Garrett, PhDPrincipal InvestigatorUniversity of Texas Health Science Center San Antonio

Media Library

Post-Traumatic Stress Disorder Research Study Groups: Trauma-focused cognitive behavioral therapy (TF-CBT), Treatment As Usual (TAU)

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Am I eligible to join this scientific investigation?

"To qualify for this study, participants must have experienced psychological traumas and be between the ages of 12 to 17. A total of 180 individuals will be recruited for the project."

Answered by AI

Are individuals above a certain age able to join this experiment?

"This clinical trial is exclusively for minors between the ages of 12 to 17. The registry currently has a total of 184 studies enrolling patients under 18 and 840 studies are recruiting those aged 65 or above."

Answered by AI

Are there any vacancies for individuals wishing to partake in this experiment?

"Affirmative. According to the details available on clinicaltrials.gov, this research project first appeared on November 29th 2022 and is still actively looking for individuals to take part in it. 180 people must be enrolled at one location."

Answered by AI

How many participants are allowed to enroll in this medical trial?

"Affirmative, clinicaltrials.gov indicates that this investigation into novel treatments is recruiting patients as of the time being. The trial was established on November 29th 2022 and has since been updated to search for 180 participants at a single location."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What site did they apply to?
UT Health Department of Psychiatry
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

I have tried multiple different medication variations, to treat my PTSD sustained in the Marine Corps and my years as a SWAT Officer. I am hoping to find something that works for me.
PatientReceived no prior treatments
~120 spots leftby Feb 2027