- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01517672
Imaging Outcomes of Cognitive Behavioral Therapy (CBT) for Battered Women With Posttraumatic Stress Disorder
January 21, 2012 updated by: Murray B. Stein, University of California, San Diego
Neurobiology of Severe Psychological Trauma in Women
Identifying neural mechanisms of posttraumatic stress disorder (PTSD) treatment could help elucidate reasons for variable treatment response and identify novel treatment targets.
Exposure-based therapies have been associated with decreased amygdala and increased cingulate cortex response during emotional processing.
The current study examined whether cognitive therapy for PTSD in women reduces activation in insula and amygdala and enhances activation in prefrontal regions during emotional anticipation and pre-treatment prefrontal activation predicts treatment response.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
41
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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California
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San Diego, California, United States, 92093
- VA San Diego Healthcare System
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 56 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Female.
- Intimate partner violence (IPV) trauma defined as physical and/or sexual abuse committed by a romantic partner, occurring within five years of, but having ended at least one month prior to, enrollment in the study.
- Seeking treatment for posttraumatic stress disorder (PTSD) symptoms and meeting full or partial Diagnostic and Statistical Manual, 4th edition (DSM-IV) criteria for PTSD prior to treatment, verified through the Clinician-Administered PTSD Scale (CAPS).
Exclusion Criteria:
- Substance abuse in the past year
- History of >2 years of alcohol abuse
- Use of psychotropic medications within 4 weeks prior to the study, bipolar disorder or schizophrenia, irremovable ferromagnetic bodily material, pregnancy, or claustrophobia.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Clinician-Administered PTSD Scale (CAPS)
Time Frame: After 10 sessions of cognitive behavioral therapy (CBT) (10-14 weeks)
|
The CAPS is a widely used measure of PTSD severity.
Intent was to administer 10 sessions of CBT over a period of 10-14 weeks.
Primary outcome was CAPS at the end of CBT administration.
|
After 10 sessions of cognitive behavioral therapy (CBT) (10-14 weeks)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
CAPS 3 months post-treatment
Time Frame: 3 months post-treatment
|
3 months post-treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2008
Primary Completion (Actual)
December 1, 2010
Study Completion (Actual)
December 1, 2010
Study Registration Dates
First Submitted
January 16, 2012
First Submitted That Met QC Criteria
January 21, 2012
First Posted (Estimate)
January 25, 2012
Study Record Updates
Last Update Posted (Estimate)
January 25, 2012
Last Update Submitted That Met QC Criteria
January 21, 2012
Last Verified
January 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STEIN VA MERIT
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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