Neural Connectivity During Therapy for Adolescent PTSD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-17
SponsorThe University of Texas Health Science Center at San Antonio
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
current or past use of psychiatric medications
severe suicidal/homicidal ideation
current hospitalization
other current psychotherapy or previous treatment with TF-CBT
Trial design
Design model
Parallel
Treatments tested in this trial
TF-CBT
Behavioralevidence-based psychotherapy for trauma in youth
TAU
Behavioraltreatment as usual
Treatment groups
180 Participants
are divided into 2 treatment groupsGroup A: Trauma-focused cognitive behavioral therapy (TF-CBT)Experimental treatment 1 intervention
Group B: Treatment As Usual (TAU)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Mean intensity within functional connectivity map of intrinsic network
functional MRI scans will be used to assess neural connectivity
Time frame
week 0 (baseline)2
Mean intensity within functional connectivity map of intrinsic network
functional MRI scans will be used to assess neural connectivity
Time frame
week 63
Mean intensity within functional connectivity map of intrinsic network
functional MRI scans will be used to assess neural connectivity
Time frame
week 124
Mean intensity within functional connectivity map of intrinsic network
functional MRI scans will be used to assess neural connectivity
Time frame
week 18Secondary 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
Time frame
Baseline to week 18Sponsors and contacts
Click on the lead sponsor to view all of their trials.
The University of Texas Health Science Center at San Antonio
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
Source ClinicalTrials.gov