Brain Response to Treatment for Pediatric PTSD

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Stanford University
Sponsor:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01806701
First received: February 27, 2013
Last updated: January 13, 2014
Last verified: January 2014
  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

Resource links provided by NLM:


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


Estimated Enrollment: 50
Study Start Date: April 2013
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 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 female 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:   12 Years to 17 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • female, ages 12-17 and past menarche; history of physical abuse or sexual abuse, English speaking

Exclusion Criteria:

  • receiving other psychotherapy 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

Contacts
Contact: Amy Garrett, Ph.D. 6507361874 agarrett@stanford.edu

Locations
United States, California
Stanford University Recruiting
Palo Alto, California, United States, 94305
Contact: Amy Garrett    650-736-1874    agarrett@stanford.edu   
Principal Investigator: Amy S Garrett, Ph.D.         
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Amy S Garrett, Ph.D. Stanford University
  More Information

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01806701     History of Changes
Other Study ID Numbers: MH097769, K01MH097769
Study First Received: February 27, 2013
Last Updated: January 13, 2014
Health Authority: United States: Federal Government

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 September 14, 2014