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Recruiting NCT05423444

Neural Connectivity During Therapy for Adolescent PTSD

No phase Interventional PTSD Adolescent Psychological Trauma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: TF-CBT, TAU.
Who it may be relevant to
Registry conditions: PTSD, Adolescent, Psychological Trauma. Basic parameters: 12 years — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Neural Connectivity Before and After Each of the Three Treatment Phases of Trauma-focused Therapy for Adolescent Posttraumatic Stress

Overview

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.

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)]
  • 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]
Secondary outcome measures (1)
  • Clinician Administered PTSD Scale - children and adolescents (CAPS-CA) [Time frame: Baseline to week 18]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Basic science

Study locations

United States · 1 center
  • UT Health Department of Psychiatry — San Antonio

Identifiers

NCT: NCT05423444 · HSC20220498H · R01MH127216

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗