Trauma-Focused Cognitive Behavioral Therapy for Psychological Trauma

Overseen By Jessica Coifman

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Washington

Disqualifiers: Prior TF-CBT training, other trauma-focused

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

34 Participants Needed

Trial Summary

What is the purpose of this trial?

This research project is a hybrid type 2 effectiveness-implementation trial that simultaneously examines (1) the effectiveness of a trauma-focused intervention for youth in the education sector and (2) the impact of a theory-driven pragmatic implementation strategy designed to increase the adoption, fidelity, and sustainment of evidence-based treatments (EBTs). This trial will include 120 clinicians and 480 students, and it is designed to test the cost effectiveness and impact of Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) in a new setting that increases access to mental health care - schools (Aim 1); test the cost effectiveness, immediate impact, and sustained impact of the Beliefs and Attitudes for Successful Implementation in Schools (BASIS) implementation strategy on proximal mechanisms and implementation outcomes (Aims 2a, 2b, 2d); and conduct sequential mixed-methods data collection to explain residuals (i.e., clinicians whose implementation behavior is unaccounted for by the mediation model) (Aim 2c).

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What data supports the effectiveness of the treatment Trauma-Focused Cognitive Behavioral Therapy for Psychological Trauma?

Trauma-focused cognitive behavioral therapy (TF-CBT) is shown to be effective for treating post-traumatic stress disorder (PTSD) in both adults and children, with improvements in daily functioning and symptom reduction. Studies indicate that TF-CBT is a recommended first-line treatment for PTSD, supported by multiple randomized controlled trials and systematic reviews. ^{1 2 3 4 5}

Is Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) safe for humans?

Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) is generally considered safe for children and adolescents with posttraumatic stress disorder (PTSD), as it is recommended as a first-line treatment in several international guidelines. However, there is limited information on its safety for individuals under ongoing threat of reexposure to trauma, and more research is needed in this area. ^{5 6 7 8 9}

How is Trauma-Focused Cognitive Behavioral Therapy different from other treatments for psychological trauma?

Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) is unique because it combines cognitive-behavioral principles with exposure techniques to address posttraumatic stress, depression, and behavioral issues, particularly in children and adolescents. It involves both the child and parent in the treatment process, focusing on modifying feelings of guilt and shame, and is especially effective for those who have experienced sexual abuse. ^{2 7 10 11 12}

Research Team

Aaron Lyon, PhD

Principal Investigator

University of Washington

Clayton Cook, PhD

Principal Investigator

University of Minnesota

Eligibility Criteria

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.

Inclusion Criteria

You are not currently receiving help for another type of therapy to treat trauma.

You have severe symptoms related to a traumatic event that may affect your ability to participate in the study.

I have never been formally trained in TF-CBT.

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) in schools to test its effectiveness and impact

6 months

Implementation Strategy

Implementation of the Beliefs and Attitudes for Successful Implementation in Schools (BASIS) strategy to increase adoption and sustainment of TF-CBT

18 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Treatment Details

Interventions

• Attention Control
• Beliefs and Attitudes for Successful Implementation in Schools (BASIS)
• Trauma-Focused Cognitive-Behavioral Therapy
• Treatment as Usual

Trial Overview 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.

Participant Groups

Group I: Enhanced Treatment as Usual Experimental Treatment 1 Intervention

Implementation intervention: non-applicable Clinical Intervention: control arm (Enhanced TAU)

Group II: BASIS with TF-CBT Experimental Treatment 2 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-CBT Experimental Treatment 2 Interventions

Implementation intervention: control arm Clinical Intervention: experimental arm (Trauma-Focused CBT)

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

University of Minnesota

Collaborator

Trials

1,459

Recruited

1,623,000+

Findings from Research

Cognitive processing therapy (CPT) significantly improved various domains of psychosocial functioning in 78 women with PTSD, regardless of whether they received the full treatment or just its components.

Reductions in PTSD symptoms, particularly emotional numbing and hyperarousal, were strongly associated with improvements in psychosocial functioning, highlighting the importance of addressing these symptoms during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Associations between functioning and PTSD symptom clusters in a dismantling trial of cognitive processing therapy in female interpersonal violence survivors. Shnaider, P., Vorstenbosch, V., Macdonald, A., et al.[2018]

Trauma-focused psychotherapy for 612 PTSD inpatients showed medium to large effects on symptom severity, anxiety, and depression, indicating its effectiveness in a routine clinical setting.

Predictors such as psychoticism, total number of diagnoses, and bronchial asthma were identified as negative indicators of treatment outcomes, suggesting that these factors could help personalize therapy for better results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of outcome during inpatient psychotherapy for posttraumatic stress disorder: a single-treatment, multi-site, practice-based study. Herzog, P., Voderholzer, U., Gärtner, T., et al.[2022]

Trauma-focused cognitive behavioral therapy (Tf-CBT) is an effective treatment for children and adolescents aged 3-17 with posttraumatic stress disorder (PTSD), supported by 13 randomized controlled trials and recognized as a first-line treatment in international guidelines.

Tf-CBT includes eight key components that help children process trauma and develop coping skills, making it a comprehensive approach that involves both the child and a supportive caregiver in the therapeutic process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Trauma-focused Cognitive-behavioral Therapy with children and adolescents: Practice, evidence base, and future directions]. Sachser, C., Rassenhofer, M., Goldbeck, L.[2018]

Trauma-focused cognitive-behavioral therapies (CBT) show medium to large effects in treating PTSD in individuals facing ongoing threats, based on a review of 21 studies involving various types of trauma exposure.

However, the safety and long-term effectiveness of these treatments for individuals under ongoing threat remain uncertain, highlighting the need for further research on potential adverse effects and treatment adaptations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trauma-focused cognitive-behavioral therapies for posttraumatic stress disorder under ongoing threat: A systematic review. Ennis, N., Sijercic, I., Monson, CM.[2021]

Trauma-Focused Cognitive-Behavioral Therapy (TF-CBT) is a highly effective treatment for reducing posttraumatic stress symptoms in children, supported by high-level evidence from ten randomized controlled trials (RCTs).

While TF-CBT shows promise in addressing trauma-related symptoms, its effectiveness in reducing behavioral problems and depression symptoms remains less certain, highlighting the need for further research to optimize its application across diverse populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trauma-focused cognitive-behavioral therapy for children and adolescents: assessing the evidence. de Arellano, MA., Lyman, DR., Jobe-Shields, L., et al.[2022]

Trauma-focused cognitive behavioral therapy (Tf-CBT) significantly reduced posttraumatic stress symptoms in children and adolescents compared to a waiting list control, as shown by a decrease in CAPS-CA scores over 4 months in a study involving 159 participants.

Younger patients and those with fewer comorbid disorders responded better to Tf-CBT, indicating that age and the presence of other mental health issues are important factors in treatment effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Trauma-Focused Cognitive Behavioral Therapy for Children and Adolescents: A Randomized Controlled Trial in Eight German Mental Health Clinics. Goldbeck, L., Muche, R., Sachser, C., et al.[2022]

A mobile phone-delivered serious game designed to enhance trauma-focused cognitive behavioral therapy (TF-CBT) for PTSD was found to be acceptable to both patients and clinicians, indicating potential for improved treatment engagement.

Both service users and clinicians suggested that the game should be therapist-guided and acknowledged that it may not be suitable for all patients, emphasizing the need for careful prescription by clinicians.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptability of a Plasticity-Focused Serious Game Intervention for Posttraumatic Stress Disorder: User Requirements Analysis. Jones, M., Denisova, A., Mitchell, S., et al.[2020]

References

1. United States pubmed.ncbi.nlm.nih.gov

Associations between functioning and PTSD symptom clusters in a dismantling trial of cognitive processing therapy in female interpersonal violence survivors. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Early intervention in post-traumatic stress disorder without exposure to trauma memories using internet-delivered cognitive therapy: A pilot case series. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Reappraisal-related neural predictors of treatment response to cognitive behavior therapy for post-traumatic stress disorder. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Predictors of outcome during inpatient psychotherapy for posttraumatic stress disorder: a single-treatment, multi-site, practice-based study. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

[Trauma-focused Cognitive-behavioral Therapy with children and adolescents: Practice, evidence base, and future directions]. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Trauma-focused cognitive-behavioral therapies for posttraumatic stress disorder under ongoing threat: A systematic review. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Trauma-focused cognitive-behavioral therapy for children and adolescents: assessing the evidence. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Effectiveness of Trauma-Focused Cognitive Behavioral Therapy for Children and Adolescents: A Randomized Controlled Trial in Eight German Mental Health Clinics. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Ten misconceptions about trauma-focused CBT for PTSD. [2023]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Focusing on trauma-focused psychotherapy for posttraumatic stress disorder. [2019]

11. Switzerland pubmed.ncbi.nlm.nih.gov

[Psychotherapy for traumatized children and adolescents--cognitive-behavioral treatments]. [2018]

12. Canada pubmed.ncbi.nlm.nih.gov

Acceptability of a Plasticity-Focused Serious Game Intervention for Posttraumatic Stress Disorder: User Requirements Analysis. [2020]