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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

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 18 months

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of WashingtonLead Sponsor

1,741 Previous Clinical Trials

1,847,732 Total Patients Enrolled

National Institute of Mental Health (NIMH)NIH

2,786 Previous Clinical Trials

2,689,733 Total Patients Enrolled

1 Trials studying Cognitive Behavioral Therapy

1,957 Patients Enrolled for Cognitive Behavioral Therapy

University of MinnesotaOTHER

1,380 Previous Clinical Trials

1,588,711 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?

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

Recent research and studies

Implementation ScienceJournal

Protocol for a Hybrid Type 2 Cluster Randomized Trial of Trauma-focused Cognitive Behavioral Therapy and a Pragmatic Individual-level Implementation Strategy

Lyon, Aaron R., Michael D. Pullmann, Shannon Dorsey, Carol Levin, Larissa M. Gaias, Stephanie K. Brewer, Madeline Larson, et al.. 2021. “Protocol for a Hybrid Type 2 Cluster Randomized Trial of Trauma-focused Cognitive Behavioral Therapy and a Pragmatic Individual-level Implementation Strategy”. Implementation Science. Springer Science and Business Media LLC. doi:10.1186/s13012-020-01064-1.

clinicaltrials.govStudy

A Hybrid Type 2 Trial of Trauma-Focused Cognitive Behavioral Therapy and a Pragmatic Individual-Level Implementation Strategy

Aaron Lyon 2020. "A Hybrid Type 2 Trial of Trauma-Focused Cognitive Behavioral Therapy and a Pragmatic Individual-Level Implementation Strategy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04451161.