{
  "FullStudy":{
    "Rank":217723,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01517672",
          "OrgStudyIdInfo":{
            "OrgStudyId":"STEIN VA MERIT"
          },
          "Organization":{
            "OrgFullName":"University of California, San Diego",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Imaging Outcomes of Cognitive Behavioral Therapy (CBT) for Battered Women With Posttraumatic Stress Disorder",
          "OfficialTitle":"Neurobiology of Severe Psychological Trauma in Women"
        },
        "StatusModule":{
          "StatusVerifiedDate":"January 2012",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"January 2008"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"December 2010",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"December 2010",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 16, 2012",
          "StudyFirstSubmitQCDate":"January 21, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 25, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"January 21, 2012",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"January 25, 2012",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Principal Investigator",
            "ResponsiblePartyInvestigatorFullName":"Murray B. Stein",
            "ResponsiblePartyInvestigatorTitle":"Professor",
            "ResponsiblePartyInvestigatorAffiliation":"University of California, San Diego"
          },
          "LeadSponsor":{
            "LeadSponsorName":"University of California, San Diego",
            "LeadSponsorClass":"OTHER"
          },
          "CollaboratorList":{
            "Collaborator":[
              {
                "CollaboratorName":"San Diego Veterans Healthcare System",
                "CollaboratorClass":"FED"
              }
            ]
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"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."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Posttraumatic Stress Disorder"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "PTSD",
              "domestic violence",
              "intimate partner violence",
              "functional MRI",
              "neuroimaging"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Not Applicable"
            ]
          },
          "DesignInfo":{
            "DesignInterventionModel":"Single Group Assignment",
            "DesignMaskingInfo":{
              "DesignMasking":"None (Open Label)"
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"41",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Behavioral",
                "InterventionName":"Cognitive Trauma Therapy for Battered Women (CTT-BW)",
                "InterventionDescription":"10 individual sessions of this form of cognitive therapy, with a trained therapist."
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Clinician-Administered PTSD Scale (CAPS)",
                "PrimaryOutcomeDescription":"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.",
                "PrimaryOutcomeTimeFrame":"After 10 sessions of cognitive behavioral therapy (CBT) (10-14 weeks)"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"CAPS 3 months post-treatment",
                "SecondaryOutcomeTimeFrame":"3 months post-treatment"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nFemale.\nIntimate 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.\nSeeking 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).\n\nExclusion Criteria:\n\nSubstance abuse in the past year\nHistory of >2 years of alcohol abuse\nUse of psychotropic medications within 4 weeks prior to the study, bipolar disorder or schizophrenia, irremovable ferromagnetic bodily material, pregnancy, or claustrophobia.",
          "HealthyVolunteers":"Accepts Healthy Volunteers",
          "Gender":"Female",
          "MinimumAge":"18 Years",
          "MaximumAge":"60 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Murray B Stein, MD, MPH",
                "OverallOfficialAffiliation":"University of California, San Diego",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"VA San Diego Healthcare System",
                "LocationCity":"San Diego",
                "LocationState":"California",
                "LocationZip":"92093",
                "LocationCountry":"United States"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000040921",
                "ConditionMeshTerm":"Stress Disorders, Traumatic"
              },{
                "ConditionMeshId":"D000013313",
                "ConditionMeshTerm":"Stress Disorders, Post-Traumatic"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000068099",
                "ConditionAncestorTerm":"Trauma and Stressor Related Disorders"
              },{
                "ConditionAncestorId":"D000001523",
                "ConditionAncestorTerm":"Mental Disorders"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M16268",
                "ConditionBrowseLeafName":"Wounds and Injuries",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M23503",
                "ConditionBrowseLeafName":"Stress Disorders, Traumatic",
                "ConditionBrowseLeafAsFound":"Stress Disorder",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M14686",
                "ConditionBrowseLeafName":"Stress Disorders, Post-Traumatic",
                "ConditionBrowseLeafAsFound":"Posttraumatic Stress Disorder",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M113",
                "ConditionBrowseLeafName":"Psychological Trauma",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M222",
                "ConditionBrowseLeafName":"Trauma and Stressor Related Disorders",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M3396",
                "ConditionBrowseLeafName":"Mental Disorders",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M13056",
                "ConditionBrowseLeafName":"Psychotic Disorders",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"BXM",
                "ConditionBrowseBranchName":"Behaviors and Mental Disorders"
              }
            ]
          }
        }
      }
    }
  }
}