NCT05423444 · The University of Texas Health Science Center at San Antonio
Neural Connectivity During Therapy for Adolescent PTSD
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
TF-CBT
evidence-based psychotherapy for trauma in youth
BEHAVIORAL
TAU
treatment as usual
Primary outcome measures
Mean intensity within functional connectivity map of intrinsic network
Time frame: week 0 (baseline)
functional MRI scans will be used to assess neural connectivity
Mean intensity within functional connectivity map of intrinsic network
Time frame: week 6
functional MRI scans will be used to assess neural connectivity
Mean intensity within functional connectivity map of intrinsic network
Time frame: week 12
functional MRI scans will be used to assess neural connectivity
Mean intensity within functional connectivity map of intrinsic network
Time frame: week 18
functional MRI scans will be used to assess neural connectivity
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- 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
Where
- San Antonio, Texas
Collaborators
National Institute of Mental Health (NIMH)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 13, 2026 · Source of record for eligibility and locations