Trauma Focused Cognitive Behavioral Therapy for Post-Traumatic Stress Disorder

Overseen By Regan Stewart, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Medical University of South Carolina

Disqualifiers: Suicidal ideation, Substance use, Psychotic symptoms, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: Varies

80 Participants Needed

Trial Summary

What is the purpose of this trial?

The current study will evaluate TF-CBT delivered via tele-health for youth presenting with trauma symptoms via a randomized controlled trial. Goals of the current study are to examine the effectiveness of Tele-TF-CBT delivered by community providers in Puerto Rico in improving youth trauma outcomes. Goals are also to support the feasibility, acceptability, and engagement outcomes of Tele-health delivery.

Eligibility Criteria

This trial is for young individuals aged 7-18 in Puerto Rico who have experienced at least one traumatic event and are showing significant post-traumatic stress symptoms. The study aims to include those who could benefit from therapy delivered remotely.

Inclusion Criteria

I have experienced a traumatic event.

I experience significant stress or trauma symptoms.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) either in clinic or via telehealth

Varies

Telehealth or in-person sessions

Post-treatment assessment

Assessment of trauma symptoms 2 weeks after completing treatment

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

3-month follow-up assessment

Treatment Details

Interventions

• Trauma Focused Cognitive Behavioral Therapy

Trial Overview The study is testing Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) provided over tele-health services to see if it's effective in improving trauma outcomes for youth when given by local community providers.

Participant Groups

Group I: Clinic-TF-CBT Active Control 1 Intervention

Trauma-Focused Cognitive Behavioral Therapy delivered in clinic (in-person)

Group II: Tele-TF-CBT Active Control 1 Intervention

Trauma-Focused Cognitive Behavioral Therapy delivered via telehealth

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+