Neural Connectivity During Therapy for Adolescent PTSD

NCT05423444 | Recruiting

• 2 other identifiers: HSC20220498HR01MH127216
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

PTSD; Adolescent; Psychological Trauma

Keywords

neuroimaging; psychotherapy; trauma; adolescent

Outcome Measures

Primary Outcomes (4)

• Mean intensity within functional connectivity map of intrinsic network

  functional MRI scans will be used to assess neural connectivity

  week 0 (baseline)

• Mean intensity within functional connectivity map of intrinsic network

  functional MRI scans will be used to assess neural connectivity

  week 6

• Mean intensity within functional connectivity map of intrinsic network

  functional MRI scans will be used to assess neural connectivity

  week 12

• Mean intensity within functional connectivity map of intrinsic network

  functional MRI scans will be used to assess neural connectivity

  week 18

Secondary Outcomes (1)

• Clinician Administered PTSD Scale - children and adolescents (CAPS-CA)

  Baseline to week 18

Study Arms (2)

Trauma-focused cognitive behavioral therapy (TF-CBT)

EXPERIMENTAL

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.

Behavioral: TF-CBT

Treatment As Usual (TAU)

ACTIVE COMPARATOR

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.

Behavioral: TAU

Interventions

TF-CBT BEHAVIORAL

evidence-based psychotherapy for trauma in youth

Trauma-focused cognitive behavioral therapy (TF-CBT)

TAU BEHAVIORAL

treatment as usual

Treatment As Usual (TAU)

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Mental Health (NIMH): collaborator
• The University of Texas Health Science Center at San Antonio: lead

Study Sites (1)

UT Health Department of Psychiatry

San Antonio, Texas, 78229, United States

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Psychological Trauma; Wounds and Injuries

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Amy Garrett, PhD

  The University of Texas Health Science Center at San Antonio

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amy Garrett, PhD

CONTACT

12105678189; garrettas@uthscsa.edu

Natalia Gomez-Giulilani

CONTACT

2105678016; gomezgiulian@uthscsa.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: An independent assessor will conduct interviews to quantify symptom severity during and after treatment. The participant will not be given specific information about treatment assignment or the differences between the two treatments.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Randomized controlled trial of Trauma-focused Cognitive Behavioral Therapy (TF-CBT) versus Treatment as Usual (TAU)

Study Record Dates

• First Submitted: June 10, 2022
• First Posted: June 21, 2022
• Study Start: November 29, 2022
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): February 28, 2027
• Last Updated: January 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Immediately following publication. No end date.
• Access Criteria: Researchers who provide a methodologically sound proposal

Locations

US (1)