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Trauma-Focused Cognitive Behavioral Therapy for Psychological Trauma

N/A
Waitlist Available
Led By Aaron Lyon, PhD
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will test the effectiveness of a trauma-focused intervention called Trauma-Focused Cognitive Behavioral Therapy (TF-CBT), as well as the impact of a theory-driven implementation strategy called Beliefs and Attitudes for Successful Implementation in Schools (BASIS). The trial will include 120 clinicians and 480 students, and will be designed to test the cost effectiveness and impact of TF-CBT in a new setting that increases access to mental health care - schools.

Who is the study for?
This trial is for school-based clinicians without prior TF-CBT training and students in grades 3-12 who have experienced trauma, like exposure to violence, and show significant stress symptoms. Clinicians already supporting another trauma-focused intervention or students outside the specified grade range cannot participate.
What is being tested?
The study tests Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) effectiveness in schools and evaluates a strategy called BASIS aimed at helping clinicians adopt and stick with evidence-based treatments. It involves 120 clinicians, 480 students, and looks into cost-effectiveness as well as long-term success.
What are the potential side effects?
Since this trial focuses on psychological therapy rather than medication, side effects are not typical in the same way they are with drugs. However, participants may experience emotional discomfort when discussing traumatic events during therapy sessions.

Timeline

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Child PTSD Symptom Scale for DSM-V
Mood and Feelings Questionnaire - Short
TF-CBT Adoption

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: Enhanced Treatment as UsualExperimental Treatment1 Intervention
Implementation intervention: non-applicable Clinical Intervention: control arm (Enhanced TAU)
Group II: BASIS with TF-CBTExperimental Treatment2 Interventions
Implementation intervention: experimental arm (Beliefs and Attitudes for Successful Implementation in Schools) Clinical Intervention: experimental arm (Trauma-Focused CBT)
Group III: AC with TF-CBTExperimental Treatment2 Interventions
Implementation intervention: control arm Clinical Intervention: experimental arm (Trauma-Focused CBT)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Attention Control
2014
Completed Phase 2
~6520
Treatment as Usual
2016
Completed Phase 3
~2710

Find a Location

Who is running the clinical trial?

University of WashingtonLead Sponsor
1,831 Previous Clinical Trials
1,907,535 Total Patients Enrolled
National Institute of Mental Health (NIMH)NIH
2,936 Previous Clinical Trials
2,742,008 Total Patients Enrolled
1 Trials studying Cognitive Behavioral Therapy
1,957 Patients Enrolled for Cognitive Behavioral Therapy
University of MinnesotaOTHER
1,439 Previous Clinical Trials
1,621,924 Total Patients Enrolled
Aaron Lyon, PhD5.0349 ReviewsPrincipal Investigator - University of Washington
Medical School - Temple University, Doctor of Medicine
University of Pennsylvania Health System (Residency)
5 Previous Clinical Trials
1,116 Total Patients Enrolled
5Patient Review
Dr. Lyons is terrific! I've seen him for a few different issues and he's been able to help me out every time. He's very knowledgeable and takes the time to explain things thoroughly. He's also got a great bedside manner. The staff at the practice are also top-notch. I would highly recommend him to anyone looking for an orthopedist.
Clayton Cook, PhDPrincipal InvestigatorUniversity of Minnesota
1 Previous Clinical Trials
51 Total Patients Enrolled

Media Library

Trauma-Focused Cognitive-Behavioral Therapy Clinical Trial Eligibility Overview. Trial Name: NCT04451161 — N/A
Cognitive Behavioral Therapy Research Study Groups: AC with TF-CBT, BASIS with TF-CBT, Enhanced Treatment as Usual
Trauma-Focused Cognitive-Behavioral Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT04451161 — N/A
~6 spots leftby Dec 2025