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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of Trauma Focused Cognitive Behavioral Therapy (TF-CBT) for young people with trauma symptoms. It compares the therapy's effectiveness when delivered in person at a clinic versus through tele-health in Puerto Rico. The goal is to determine which method better aids trauma recovery and proves more feasible and engaging for participants. Young people aged 7 to 18 who have experienced at least one traumatic event and exhibit significant trauma symptoms might be suitable for this study. As an unphased trial, it offers participants the chance to contribute to important research that could enhance trauma therapy options for young people.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that Tele-TF-CBT is safe for youth with trauma symptoms?

Research shows that Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) is generally safe for treating post-traumatic stress disorder (PTSD) in children and teens. Studies have found that TF-CBT effectively reduces PTSD symptoms using structured techniques that young people can easily handle.

For Tele-TF-CBT, research suggests that delivering TF-CBT through telehealth is practical and safe for young people. Although some challenges exist in completing treatment, safety concerns remain minimal. The telehealth method has been used in various settings, demonstrating good technical performance without major safety issues.

Both in-person and telehealth versions of TF-CBT have been studied and found to be safe, with few negative effects reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Trauma Focused Cognitive Behavioral Therapy (TF-CBT) because it offers flexible treatment delivery options for Post-Traumatic Stress Disorder (PTSD). Unlike traditional in-person therapy sessions, TF-CBT can be delivered both in-clinic and via telehealth, making it more accessible to people who may face barriers to attending therapy sessions, such as transportation issues or living in remote areas. This flexibility can help reach a broader audience and ensure that more individuals receive necessary mental health support. Additionally, TF-CBT is specifically tailored to address trauma, making it a targeted approach compared to more general therapeutic methods.

What evidence suggests that this trial's treatments could be effective for PTSD?

Studies have shown that Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) effectively reduces symptoms of post-traumatic stress disorder (PTSD) in children and teenagers. This therapy typically involves 8-25 sessions and successfully addresses various trauma-related issues. In this trial, participants will receive either in-person (Clinic-TF-CBT) or online (Tele-TF-CBT) versions of the therapy. Research indicates that both versions can significantly reduce PTSD symptoms. Specifically, a small study of online TF-CBT showed major improvements in symptoms, as reported by both young participants and their caregivers. Overall, TF-CBT, whether conducted in person or online, is a well-supported treatment for managing PTSD in young people. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4396183/

Trauma-Focused Cognitive Behavioral Therapy: Assessing ... TF-CBT has demonstrated positive outcomes in reducing symptoms of posttraumatic stress disorder, although it is less clear whether TF-CBT is effective in ...

2. tfcbt.org tfcbt.org/about/

About Trauma-Focused Cognitive Behavior Therapy ... TF-CBT is a structured, short-term treatment model that effectively improves a range of trauma-related outcomes in 8-25 sessions with the child/adolescent and ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0163834323001883

The efficacy and acceptability of group trauma-focused ... Group trauma-focused CBT significantly alleviates post-traumatic stress disorder symptoms in youth, demonstrating efficacy post-treatment and during follow-up.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06516874

A Pilot Clinical Trial of Trauma-Focused Cognitive ... Randomized controlled trials have shown that trauma-focused cognitive behavioral therapy (TF-CBT) is effective in reducing PTSD symptoms; however, there is ...

5. psycnet.apa.org psycnet.apa.org/record/2026-17551-001

Efficacy of cognitive behavioral therapies with a trauma focus ... This individual participant data meta-analysis aimed to investigate the effectiveness of cognitive behavioral therapy with a trauma focus (CBT-TF) for ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0272735821000921

Review Trauma-focused cognitive-behavioral therapies for ... This paper systematically reviewed the effectiveness of CBTs for PTSD in individuals with ongoing threat of reexposure.

7. frontiersin.org frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2017.00092/full

Integrated Trauma-Focused Cognitive-Behavioural ... Recent evidence demonstrates that it is safe to use reprocessing strategies in this population. However, most published studies have been based ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4476061/

Trauma-Focused Cognitive Behavioral Therapy for ... Trauma-focused therapy can help parents recognize and respond appropriately to their children's trauma responses while setting appropriate behavioral limits.