Brain Response to Treatment for Pediatric PTSD
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|ClinicalTrials.gov Identifier: NCT01806701|
Recruitment Status : Completed
First Posted : March 7, 2013
Last Update Posted : October 13, 2016
|Condition or disease||Intervention/treatment||Phase|
|Emotions Memory Deficits Post-traumatic Syndrome||Behavioral: Trauma-focused cognitive behavioral therapy||Not Applicable|
This is a neuroimaging study of changes in brain function associated with trauma-focused cognitive behavioral therapy (TF-CBT)for abused youth suffering from PTSD. By scanning patients before and after treatment, the investigators will identify mediators (potential mechanisms) of recovery from PTSD.
Childhood maltreatment is unfortunately common, and can lead to significant problems in school, emotional difficulties, and physical ailments. Frequently, abused children develop symptoms of posttraumatic stress disorder (PTSD), such as re-experiencing aspects of the trauma, avoiding trauma-related situations, and suffering from chronic hyperarousal. PTSD can inflict significant stress-related damage on the brain at any age, but may be particularly damaging during developmental periods such as adolescence. Therefore, effective treatments for PTSD in youth are critical, and this depends in part on our ability to understand the neural abnormalities underlying pediatric PTSD, and the brain changes accompanying recovery from PTSD.
TF-CBT is the "gold-standard" treatment for this population however, some patients continue to experience symptoms of PTSD following treatment. Examining neural changes associated with successful treatment may suggest adjunctive or additional steps to enhance recovery in non-responders or partly responsive patients.
The investigators will assess brain activation in response to an emotion-related task in 40 adolescents with PTSD before and after a 12 week TF-CBT treatment, conducted at Stanford University. The fidelity of TF-CBT treatment will be assured through ongoing consultation between clinicians and treatment co-creator Judith Cohen, M.D. Neuroimaging analyses will assess patterns of activation associated with response to TF-CBT. Also, the investigators will scan 30 age-matched healthy controls recruited from the same community, to compare with patients to identify abnormalities in brain structure and function in the PTSD group. Controls will be scanned before and after a 12-week interval as well, to allow analyses of test/retest reliability of fMRI measures in this age group.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||68 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Biomarkers of Clinical Response to Cognitive Treatment of PTSD in Youth|
|Study Start Date :||April 2013|
|Actual Primary Completion Date :||May 2016|
|Actual Study Completion Date :||May 2016|
Trauma-focused Cognitive Behavioral Therapy
Behavioral: Trauma-focused cognitive behavioral therapy
the 'gold-standard' behavioral treatment for children/adolescents with posttraumatic stress disorder
Other Name: TF-CBT
- functional magnetic resonance imaging (brain activation) [ Time Frame: change in brain activation after 4 months of treatment (baseline and 4 months) ]We will use functional magnetic resonance imaging to measure changes in brain activation after 4 months of psychotherapy
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01806701
|United States, California|
|Palo Alto, California, United States, 94305|
|Principal Investigator:||Amy S Garrett, Ph.D.||Stanford University|