Neural Connectivity During Therapy for Adolescent PTSD

NCT ID: NCT05423444

Last Updated: 2026-01-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-29
• Study Completion Date: 2027-02-28

Brief Summary

Posttraumatic stress disorder in adolescence impairs neurobiological networks underlying cognitive, social and emotional skills. Neuroimaging research that seeks to identify the neural mechanisms of treatments for PTSD could lead to novel treatments, but progress has been slow using current methods. The proposed study uses an innovative approach to identify neural mechanisms of specific phases of trauma-focused therapy for youth with PTSD, allowing a new understanding of brain changes associated with the process of therapy.

Detailed Description

Posttraumatic stress disorder (PTSD) during adolescence negatively impacts brain networks underlying cognitive, social, and emotional function. Early intervention is important for mitigating long-term effects, but about 20% of youth do not improve sufficiently with current approaches. By identifying the neurobiological mechanisms of effective therapies, the investigators facilitate the development of novel or personalized treatment approaches for youth with PTSD. However, there has been limited progress in identifying the neural mechanisms of treatment using neuroimaging, partly because most studies collect neuroimaging data at only baseline and end-of-treatment, which collapses across multiple parts of the therapeutic process. The objective of the proposed study is to take a new approach by identifying neural mechanisms associated with specific phases of trauma therapy for youth with PTSD. The central hypothesis is that each phase produces specific brain changes that reflect the acquisition of skills and experiences occurring during that phase. Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) is evidence-based and widely-used to treat children and adolescents with PTSD. It consists of 3 well-defined phases, providing an opportunity to test hypotheses with neuroimaging: changes in executive control networks will occur during the skills phase, changes in limbic networks during the narrative phase, and changes in default mode networks during the consolidation phase. To test these hypotheses, the investigators will recruit N=180 girls and boys, ages 12-17, who have PTSD following interpersonal trauma, such as physical abuse, sexual abuse, or witnessing violence. A randomized controlled trial design will be used to assign participants to either Trauma-focused Cognitive Behavioral Therapy (TF-CBT; provided by study team clinicians who meet fidelity standards) or Treatment as Usual (TAU; provided in the community and does not follow a phased structure). Functional magnetic resonance imaging (fMRI) data will be collected before and after each of the 3 phases of TF-CBT or the same time intervals of TAU. Individual differences in age, sex, dissociative subtype, symptom severity and other variables will be investigated as covariates of phase-related neural changes. Analyses will identify the phases of TF-CBT for which brain regions and networks change for the TF-CBT but not the TAU group. The phase(s) that best predict end-of-treatment symptom improvement also will be identified. Exploratory analyses will use neuroanatomical and white matter diffusivity scans to identify co-occurring changes in brain structure. The proposed innovative study will provide novel information on the neurobiological and cognitive mechanisms associated with the process of trauma therapy for youth with PTSD.

Conditions

PTSD; Adolescent; Psychological Trauma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Trauma-focused cognitive behavioral therapy (TF-CBT)

Trauma-focused Cognitive Behavioral Therapy (TF-CBT) is an evidence-based psychotherapy that is considered the gold-standard treatment for trauma in youth. The TF-CBT model is flexible but it follows a specific order of phases and components, including psychoeducation, emotion regulation skills, processing the trauma narrative, and safety planning. Sessions are provided weekly for 18-weeks.

Group Type: EXPERIMENTAL

TF-CBT

Intervention Type: BEHAVIORAL

evidence-based psychotherapy for trauma in youth

Treatment As Usual (TAU)

Treatment as usual (TAU) consists of the standard-of-care psychotherapy as provided by licensed clinicians at a local clinic. The order and choice of techniques is based on the knowledge and preferences of the clinicians. Sessions are provided weekly for 18-weeks.

Group Type: ACTIVE_COMPARATOR

TAU

Intervention Type: BEHAVIORAL

treatment as usual

Interventions

TF-CBT

evidence-based psychotherapy for trauma in youth

Intervention Type: BEHAVIORAL

TAU

treatment as usual

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• ages 12-17 and Tanner stage 2 or above
• history of interpersonal trauma
• PTSD symptoms with a rating of '2' or higher on at least one symptom from each of the 4 clusters, using the Clinician-Administered PTSD Scale for Children and Adolescents, and having a duration of at least one month

Exclusion Criteria

• current or past use of psychiatric medications
• severe suicidal/homicidal ideation
• current hospitalization
• other current psychotherapy or previous treatment with TF-CBT
• history of head injury with loss of consciousness for >5 minutes
• IQ<85
• major medical illness
• MRI contraindications (metal in body; braces on teeth)
• psychosis, bipolar 1, autism, developmental disorder, panic disorder
• first-degree family member with diagnosis of psychosis or bipolar I disorder
• substance dependence within the past 3 months or current drug use that is frequent

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

The University of Texas Health Science Center at San Antonio

OTHER

Sponsor Role: lead

Responsible Party

Amy Garrett, PhD

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amy Garrett, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Texas Health Science Center San Antonio

Locations

UT Health Department of Psychiatry

San Antonio, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Amy Garrett, PhD

Role: CONTACT

garrettas@uthscsa.edu

12105678189

Natalia Gomez-Giulilani

Role: CONTACT

gomezgiulian@uthscsa.edu

2105678016

Facility Contacts

Amy Garrett, PhD

Role: primary

garrettas@uthscsa.edu

2105678189

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

R01MH127216

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HSC20220498H

Identifier Type: -

Identifier Source: org_study_id