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Imaging Outcomes of Cognitive Behavioral Therapy (CBT) for Battered Women With Posttraumatic Stress Disorder

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01517672
First Posted: January 25, 2012
Last Update Posted: January 25, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
San Diego Veterans Healthcare System
Information provided by (Responsible Party):
Murray B. Stein, University of California, San Diego
  Purpose
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.

Condition Intervention
Posttraumatic Stress Disorder Behavioral: Cognitive Trauma Therapy for Battered Women (CTT-BW)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Neurobiology of Severe Psychological Trauma in Women

Resource links provided by NLM:


Further study details as provided by Murray B. Stein, University of California, San Diego:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • CAPS 3 months post-treatment [ Time Frame: 3 months post-treatment ]

Enrollment: 41
Study Start Date: January 2008
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Cognitive Trauma Therapy for Battered Women (CTT-BW)
    10 individual sessions of this form of cognitive therapy, with a trained therapist.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01517672


Locations
United States, California
VA San Diego Healthcare System
San Diego, California, United States, 92093
Sponsors and Collaborators
University of California, San Diego
San Diego Veterans Healthcare System
Investigators
Principal Investigator: Murray B Stein, MD, MPH University of California, San Diego
  More Information

Responsible Party: Murray B. Stein, Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT01517672     History of Changes
Other Study ID Numbers: STEIN VA MERIT
First Submitted: January 16, 2012
First Posted: January 25, 2012
Last Update Posted: January 25, 2012
Last Verified: January 2012

Keywords provided by Murray B. Stein, University of California, San Diego:
PTSD
domestic violence
intimate partner violence
functional MRI
neuroimaging

Additional relevant MeSH terms:
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders