Recruiting

Neural Connectivity

Sponsor:

The University of Texas Health Science Center at San Antonio

Code:

NCT05423444

Conditions

PTSD

Adolescent

Psychological Trauma

Eligibility Criteria

Sex: All

Age: 12 - 17

Healthy Volunteers: Not accepted

Interventions

TF-CBT

TAU

Study Details

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

Study ID

NCT05423444

Start date

Nov 29, 2022

Status verified date

Jan, 2026

Completion date

Feb 28, 2027

Anticipated

Primary completion date

Feb 28, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 17

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

180 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: 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.

active comparator: 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.

Interventions

TF-CBT

evidence-based psychotherapy for trauma in youth

TAU

treatment as usual

Primary outcome measure

  • Mean intensity within functional connectivity map of intrinsic network [ Time Frame: week 0 (baseline) ]
  • Mean intensity within functional connectivity map of intrinsic network [ Time Frame: week 6 ]
  • Mean intensity within functional connectivity map of intrinsic network [ Time Frame: week 12 ]
  • Mean intensity within functional connectivity map of intrinsic network [ Time Frame: week 18 ]

Central Contacts and Locations

Central contacts

Amy Garrett, PhD

12105678189garrettas@uthscsa.edu

Natalia Gomez-Giulilani

2105678016gomezgiulian@uthscsa.edu

Locations

UT Health Department of Psychiatry

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Amy Garrett, PhD

2105678189garrettas@uthscsa.edu

More Information

Sponsor

The University of Texas Health Science Center at San Antonio

Last update posted

Jan 13, 2026

Last verified

Jan, 2026

Keywords

  • neuroimaging
  • psychotherapy
  • trauma
  • adolescent

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center at San Antonio on 2026-01-13.