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

Posttraumatic Stress Disorder Clinical Trial

Official title:

Neurobiology of Severe Psychological Trauma in Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01517672
• Other study ID #: STEIN VA MERIT
• Status: Completed
• Phase: N/A
• First received: January 16, 2012
• Last updated: January 21, 2012
• Start date: January 2008
• Est. completion date: December 2010

Study information

• Verified date: January 2012
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• Cognitive Trauma Therapy for Battered Women (CTT-BW)
10 individual sessions of this form of cognitive therapy, with a trained therapist.

Locations

Country	Name	City	State
United States	VA San Diego Healthcare System	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Diego	San Diego Veterans Healthcare System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinician-Administered PTSD Scale (CAPS)	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)	No
Secondary	CAPS 3 months post-treatment		3 months post-treatment	No