PTSDNCT05423444
Neural Connectivity During Therapy for Adolescent PTSD
A study testing TF-CBT and TAU in people with PTSD and Adolescent, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- PTSD, Adolescent, Psychological Trauma
- What is being tested?
- TF-CBT and TAU
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Nov 2022to 28 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UT Health Department of Psychiatry
San Antonio, Texas, 78229
Amy Garrett, PhD, 2105678189, garrettas@uthscsa.edu
About this study
Official title: Neural Connectivity Before and After Each of the Three Treatment Phases of Trauma-focused Therapy for Adolescent Posttraumatic Stress
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.
Read the 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
- Being tested
- TF-CBT, TAU
- Keywords
- neuroimaging, psychotherapy, trauma, adolescent
- Medical subject headings
- Stress Disorders, Post-Traumatic, Psychological Trauma, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TF-CBTBehavioural
evidence-based psychotherapy for trauma in youth
TAUBehavioural
treatment as usual
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: TAU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean intensity within functional connectivity map of intrinsic network
functional MRI scans will be used to assess neural connectivity
Measured: week 0 (baseline)
Mean intensity within functional connectivity map of intrinsic network
functional MRI scans will be used to assess neural connectivity
Measured: week 6
Mean intensity within functional connectivity map of intrinsic network
functional MRI scans will be used to assess neural connectivity
Measured: week 12
Mean intensity within functional connectivity map of intrinsic network
functional MRI scans will be used to assess neural connectivity
Measured: week 18
Secondary outcomes (1)
Clinician Administered PTSD Scale - children and adolescents (CAPS-CA)
interview to assess for frequency and severity of PTSD symptoms during the past week
Measured: Baseline to week 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start29 Nov 2022
- Primary completion28 Feb 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial of Trauma-focused Cognitive Behavioral Therapy (TF-CBT) versus Treatment as Usual (TAU)
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center at San Antonio
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Amy Garrett, PhD, The University of Texas Health Science Center at San Antonio
- Investigators
- Amy Garrett, PhD, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05423444
- Sponsor's protocol ID
- HSC20220498H
- Other IDs
- R01MH127216
- Status last verified
- Jan 2026
- First submitted
- 10 Jun 2022
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sharing plan and reporting of milestones will conform to all preferred NIMH guidelines, as detailed in the NDA Data sharing terms and conditions. Global unique identifiers (GUIDs) will be generated for each study subject. Data will be submitted to NDA every 6 months. We will provide a data submission agreement. The NDA validation tool will be used frequently. The clinical trial protocol also will be submitted as additional information for every collection. Progress reports will include a statement on the progress of data sharing. 1. Summary of data to be shared: neuroimaging, clinical, demographic, phenotypic, neuropsychological 2. Description of the data dictionaries used to describe the data set: Axis 1 diagnoses, CDI, CAPS-CA, fMRI behavior, beta weights, network correlations 3. Proposed schedule to validate that the data are compliant with the data dictionary: Data will be validated on a quarterly basis
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Connectivity Before and After Each of the Three Treatment Phases of Trauma-focused Therapy for Adolescent Posttraumatic Stress
- ClinicalTrials.gov ID
- NCT05423444
- Acronym / sponsor ID
- HSC20220498H
- Conditions
- PTSD, Adolescent, Psychological Trauma
- Keywords
- neuroimaging, psychotherapy, trauma, adolescent
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 29 Nov 2022 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 21 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial of Trauma-focused Cognitive Behavioral Therapy (TF-CBT) versus Treatment as Usual (TAU)
| Arm | Type | Receives |
|---|---|---|
| Trauma-focused cognitive behavioral therapy (TF-CBT) | Experimental | Behavioral: TF-CBTTrauma-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. |
| Treatment As Usual (TAU) | Active comparator | Behavioral: TAUTreatment 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. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TF-CBTevidence-based psychotherapy for trauma in youth | Behavioural | Trauma-focused cognitive behavioral therapy (TF-CBT) |
| TAUtreatment as usual | Behavioural | Treatment As Usual (TAU) |
Primary outcome
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
1 secondary outcome
Clinician Administered PTSD Scale - children and adolescents (CAPS-CA)
Time frame: Baseline to week 18
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
- Individual participant dataSharing planned: Yes. The data sharing plan and reporting of milestones will conform to all preferred NIMH guidelines, as detailed in the NDA Data sharing terms and conditions. Global unique identifiers (GUIDs) will be generated for each study subject. Data will be submitted to NDA every 6 months. We will provide a data submission agreement. The NDA validation tool will be used frequently. The clinical trial protocol also will be submitted as additional information for every collection. Progress reports will include a statement on the progress of data sharing. 1. Summary of data to be shared: neuroimaging, clinical, demographic, phenotypic, neuropsychological 2. Description of the data dictionaries used to describe the data set: Axis 1 diagnoses, CDI, CAPS-CA, fMRI behavior, beta weights, network correlations 3. Proposed schedule to validate that the data are compliant with the data dictionary: Data will be validated on a quarterly basis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amy Garrett, PhD principal investigator
The University of Texas Health Science Center at San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TF-CBT and TAU in people with PTSD and Adolescent, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amy Garrett, PhD (12105678189, garrettas@uthscsa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean intensity within functional connectivity map of intrinsic network (time frame: week 0 (baseline)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026.