Imaging Outcomes of Cognitive Behavioral Therapy (CBT) for Battered Women With Posttraumatic Stress Disorder
This study has been completed.
Sponsor:
University of California, San Diego
Collaborator:
San Diego Veterans Healthcare System
Information provided by (Responsible Party):
Murray B. Stein, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT01517672
First received: January 16, 2012
Last updated: January 21, 2012
Last verified: January 2012
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | January 16, 2012 | ||||
| Last Updated Date | January 21, 2012 | ||||
| Start Date ICMJE | January 2008 | ||||
| Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Clinician-Administered PTSD Scale (CAPS) [ Time Frame: After 10 sessions of cognitive behavioral therapy (CBT) (10-14 weeks) ] [ Designated as safety issue: No ] 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. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01517672 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
CAPS 3 months post-treatment [ Time Frame: 3 months post-treatment ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Imaging Outcomes of Cognitive Behavioral Therapy (CBT) for Battered Women With Posttraumatic Stress Disorder | ||||
| Official Title ICMJE | Neurobiology of Severe Psychological Trauma in Women | ||||
| Brief Summary | 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Intervention Model: Single Group Assignment Masking: Open Label |
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| Condition ICMJE | Posttraumatic Stress Disorder | ||||
| Intervention ICMJE | Behavioral: Cognitive Trauma Therapy for Battered Women (CTT-BW)
10 individual sessions of this form of cognitive therapy, with a trained therapist. |
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| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 41 | ||||
| Completion Date | December 2010 | ||||
| Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 18 Years to 60 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01517672 | ||||
| Other Study ID Numbers ICMJE | STEIN VA MERIT | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Murray B. Stein, University of California, San Diego | ||||
| Study Sponsor ICMJE | University of California, San Diego | ||||
| Collaborators ICMJE | San Diego Veterans Healthcare System | ||||
| Investigators ICMJE |
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| Information Provided By | University of California, San Diego | ||||
| Verification Date | January 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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