Brain Response to Treatment for Pediatric PTSD
Primary Purpose
Emotions, Memory Deficits, Post-traumatic Syndrome
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Trauma-focused cognitive behavioral therapy
Sponsored by
About this trial
This is an interventional basic science trial for Emotions focused on measuring fMRI, neuroimaging, PTSD, adolescent, trauma, brain
Eligibility 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.
Sites / Locations
- Stanford University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Psychotherapy
Arm Description
Trauma-focused Cognitive Behavioral Therapy
Outcomes
Primary Outcome Measures
functional magnetic resonance imaging (brain activation)
We will use functional magnetic resonance imaging to measure changes in brain activation after 4 months of psychotherapy
Secondary Outcome Measures
Full Information
NCT ID
NCT01806701
First Posted
February 27, 2013
Last Updated
October 12, 2016
Sponsor
Stanford University
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT01806701
Brief Title
Brain Response to Treatment for Pediatric PTSD
Official Title
Biomarkers of Clinical Response to Cognitive Treatment of PTSD in Youth
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emotions, Memory Deficits, Post-traumatic Syndrome
Keywords
fMRI, neuroimaging, PTSD, adolescent, trauma, brain
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
68 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Psychotherapy
Arm Type
Experimental
Arm Description
Trauma-focused Cognitive Behavioral Therapy
Intervention Type
Behavioral
Intervention Name(s)
Trauma-focused cognitive behavioral therapy
Other Intervention Name(s)
TF-CBT
Intervention Description
the 'gold-standard' behavioral treatment for children/adolescents with posttraumatic stress disorder
Primary Outcome Measure Information:
Title
functional magnetic resonance imaging (brain activation)
Description
We will use functional magnetic resonance imaging to measure changes in brain activation after 4 months of psychotherapy
Time Frame
change in brain activation after 4 months of treatment (baseline and 4 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy S Garrett, Ph.D.
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94305
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Brain Response to Treatment for Pediatric PTSD
We'll reach out to this number within 24 hrs