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Brain Response to Treatment for Pediatric PTSD

This study has been completed.
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Amy Sue Garrett, Stanford University
ClinicalTrials.gov Identifier:
NCT01806701
First received: February 27, 2013
Last updated: October 12, 2016
Last verified: October 2016
  Purpose
This study will examine how brain activation changes as a result of behavioral treatment for posttraumatic stress disorder (PTSD) in adolescents. The investigators will conduct functional magnetic resonance imaging (fMRI) scans before and after the widely-used trauma-focused cognitive behavioral therapy to better understand how the brain recovers from illness. This study will provide much needed information about brain abnormalities in abused youth, and could lead to improvements in behavioral treatments for patients who do not respond to current treatments.

Condition Intervention
Emotions
Memory Deficits
Post-traumatic Syndrome
Behavioral: Trauma-focused cognitive behavioral therapy

Study Type: Interventional
Study Design: Endpoint Classification: Bio-equivalence Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Biomarkers of Clinical Response to Cognitive Treatment of PTSD in Youth

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • functional magnetic resonance imaging (brain activation) [ Time Frame: change in brain activation after 4 months of treatment (baseline and 4 months) ] [ Designated as safety issue: No ]
    We will use functional magnetic resonance imaging to measure changes in brain activation after 4 months of psychotherapy


Enrollment: 68
Study Start Date: April 2013
Study Completion Date: May 2016
Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Psychotherapy
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   9 Years to 17 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • ages 12-17, history of physical or sexual abuse, witnessing violence, or bullying; and English speaking

Exclusion Criteria:

  • receiving other psychotherapy currently, taking medications for a psychiatric disorder currently, history of head injury with loss of consciousness longer than 5 minutes; major medical condition such as epilepsy, diabetes, heart disease, or loss of hearing or vision, developmental disorder such as fragile X, autism, or Down's Syndrome, MRI contraindications including metal in the body from an injury or surgery, non-removeable piercings, or braces, Intelligence Quotient (IQ) < 70; schizophrenia, bipolar disorder, current substance abuse.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01806701

Locations
United States, California
Stanford University
Palo Alto, California, United States, 94305
Sponsors and Collaborators
Stanford University
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Amy S Garrett, Ph.D. Stanford University
  More Information

Responsible Party: Amy Sue Garrett, Principle Investigator, Stanford University
ClinicalTrials.gov Identifier: NCT01806701     History of Changes
Other Study ID Numbers: MH097769  K01MH097769 
Study First Received: February 27, 2013
Last Updated: October 12, 2016
Health Authority: United States: Federal Government
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Stanford University:
fMRI
neuroimaging
PTSD
adolescent
trauma
brain

Additional relevant MeSH terms:
Memory Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on December 02, 2016