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Trauma-Focused Cognitive Behavioral Therapy for Psychological Trauma

N/A
Recruiting
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
(b) have not previously received formal training in TF-CBT;
(a) be within the TF-CBT developmental range (grades 3 -12);
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have never been formally trained in TF-CBT.
Select...
I am a student in grades 3 through 12.

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

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

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
1,737 Previous Clinical Trials
1,843,427 Total Patients Enrolled
National Institute of Mental Health (NIMH)NIH
2,781 Previous Clinical Trials
2,674,944 Total Patients Enrolled
1 Trials studying Cognitive Behavioral Therapy
1,957 Patients Enrolled for Cognitive Behavioral Therapy
University of MinnesotaOTHER
1,377 Previous Clinical Trials
1,588,263 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

Frequently Asked Questions

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

Does this trial include participants of over two decades in age?

"According to the criteria of this trial, candidates must be between 7 and 85 years old."

Answered by AI

Might I be qualified to partake in this medical research?

"This study seeks to enroll 34 clinicians and students between the ages of 7-85 who are affiliated with school health services. In order for applicants to be considered, they must fulfill specific criteria: Clinicians will only qualify if they (a) offer services in a participating district; (b) have not been formally trained in TF-CBT beforehand; and (c) are not currently receiving support for another trauma based program. For student subjects, qualifying factors include being within the predetermined developmental range (3rd -12th grade), exposure to some form traumatic event, as well as presenting significant signs of PTSD."

Answered by AI

Is the enrollment period for this trial currently accessible?

"Affirmative. The information available on clinicaltrials.gov confirms that this research trial is actively recruiting participants, with the initial post date being August 27th 2020 and the most recent edit occurring October 13th 2022. 34 volunteers are needed for 1 medical centre to complete the project."

Answered by AI

How many participants are involved in this clinical trial?

"Affirmative. Clinicaltrials.gov shows that this clinical trial is actively seeking patients, with an original posting date of August 27th 2020 and a last update on October 13th 2022. The study requires 34 participants to be drawn from one medical centre."

Answered by AI

Who else is applying?

What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
3+

What questions have other patients asked about this trial?

Is this a medication trial, or a therapy modality trial, or both? Can the therapy be conducted via Zoom, since I am in Portland, Oregon?
PatientReceived no prior treatments

Why did patients apply to this trial?

I have tried four drugs that have not worked (exquisite sensitivity to medications) and therapy modalities to date have only worsened symptoms (CBT, DBT, EMDR). Am at wit's end.
PatientReceived 2+ prior treatments
~1 spots leftby Jun 2024