NCT01806701

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 27, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 7, 2013

Completed
25 days until next milestone

Study Start

First participant enrolled

April 1, 2013

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

October 13, 2016

Status Verified

October 1, 2016

Enrollment Period

3.1 years

First QC Date

February 27, 2013

Last Update Submit

October 12, 2016

Conditions

Keywords

fMRIneuroimagingPTSDadolescenttraumabrain

Outcome Measures

Primary Outcomes (1)

  • functional magnetic resonance imaging (brain activation)

    We will use functional magnetic resonance imaging to measure changes in brain activation after 4 months of psychotherapy

    change in brain activation after 4 months of treatment (baseline and 4 months)

Study Arms (1)

Psychotherapy

EXPERIMENTAL

Trauma-focused Cognitive Behavioral Therapy

Behavioral: Trauma-focused cognitive behavioral therapy

Interventions

the 'gold-standard' behavioral treatment for children/adolescents with posttraumatic stress disorder

Also known as: TF-CBT
Psychotherapy

Eligibility Criteria

Age9 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University

Palo Alto, California, 94305, United States

Location

MeSH Terms

Conditions

Memory DisordersStress Disorders, Post-TraumaticWounds and Injuries

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsStress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Amy S Garrett, Ph.D.

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

February 27, 2013

First Posted

March 7, 2013

Study Start

April 1, 2013

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

October 13, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations