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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

Must not have

Current hospitalization

Current or past use of psychiatric medications

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 18

Awards & highlights

No Placebo-Only Group

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.

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.

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

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently in the hospital.

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I have used psychiatric medications in the past or am currently using them.

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A close family member has been diagnosed with psychosis or bipolar I disorder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 18

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Mean intensity within functional connectivity map of intrinsic network

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 5Eligibility criteria met