{
  "FullStudy":{
    "Rank":218110,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01512602",
          "OrgStudyIdInfo":{
            "OrgStudyId":"RHP-DiaS-002"
          },
          "Organization":{
            "OrgFullName":"Mental Health Services in the Capital Region, Denmark",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Efficacy of Dialectical Behavior Therapy Versus CAMS-informed Supportive Psychotherapy on Self Harming Behavior",
          "OfficialTitle":"Efficacy of Dialectical Behavior Therapy in Patient With Self Harming Behavior and Traits Within the Spectrum of Borderline Personality Disorder.",
          "Acronym":"DiaS"
        },
        "StatusModule":{
          "StatusVerifiedDate":"April 2015",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"January 2012"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"July 2014",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"July 2014",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"December 21, 2011",
          "StudyFirstSubmitQCDate":"January 14, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 19, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"April 25, 2015",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"April 28, 2015",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Principal Investigator",
            "ResponsiblePartyInvestigatorFullName":"Merete Nordentoft",
            "ResponsiblePartyInvestigatorTitle":"Professor, MD",
            "ResponsiblePartyInvestigatorAffiliation":"Mental Health Services in the Capital Region, Denmark"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Mental Health Services in the Capital Region, Denmark",
            "LeadSponsorClass":"OTHER"
          },
          "CollaboratorList":{
            "Collaborator":[
              {
                "CollaboratorName":"Lundbeck Foundation",
                "CollaboratorClass":"OTHER"
              },{
                "CollaboratorName":"University of Copenhagen",
                "CollaboratorClass":"OTHER"
              }
            ]
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"Purpose: The purpose of this study is to investigate the efficacy of Dialectical Behavior Therapy (DBT) versus CAMS (Collaborative Assessment and Management of Suicidality) -informed supportive psychotherapy on the risk of self-harm acts and suicide attempts in patients with self behavior and personality traits within the spectrum of borderline personality disorder.\n\nHypothesis: The hypothesis is 16 weeks of treatment with Dialectical Behavior Therapy (DBT) after a defined manual has a higher efficacy than CAMS-informed supportive psychotherapy on self-harm acts, suicide attempts, suicidal ideation, depressive symptoms, impulsiveness and consumption of hospital services in patients with symptoms within the spectrum of borderline personality disorder (BDP).\n\nMethod: The investigators will include 160 patients in the randomized trial to investigate whether 16 weeks of DBT-treatment as a higher efficacy than CAMS-informed supportive psychotherapy on the risk of self-harm acts and suicide attempts in patients with self-harm behavior and personality traits within the spectrum of borderline personality disorder. The trial will meet strict criteria for high quality randomized trials, and will hopefully help to establish evidence for the treatment of this patient group at higher risk of later suicide. There will be performed follow up interviews after 16 weeks, 28 weeks and 52 weeks."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Borderline Personality Disorder",
              "Suicide"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "Borderline Personality Disorder traits",
              "Suicide prevention",
              "Self-harm",
              "Dialectical Behavior Therapy",
              "DBT",
              "Collaborative Assessment and Management of Suicidology",
              "CAMS"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Not Applicable"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Parallel Assignment",
            "DesignPrimaryPurpose":"Treatment",
            "DesignMaskingInfo":{
              "DesignMasking":"Double",
              "DesignWhoMaskedList":{
                "DesignWhoMasked":[
                  "Investigator",
                  "Outcomes Assessor"
                ]
              }
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"108",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Dialectical Behavior Therapy DBT",
                "ArmGroupType":"Active Comparator",
                "ArmGroupDescription":"16 weeks DBT-treatment",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Behavioral: DBT"
                  ]
                }
              },{
                "ArmGroupLabel":"CAMS",
                "ArmGroupType":"Active Comparator",
                "ArmGroupDescription":"Collaborative Assessment and Management of Suicidality, CAMS-informed supportive psychotherapy",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Behavioral: CAMS"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Behavioral",
                "InterventionName":"DBT",
                "InterventionDescription":"16 weeks DBT treatment",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Dialectical Behavior Therapy DBT"
                  ]
                }
              },{
                "InterventionType":"Behavioral",
                "InterventionName":"CAMS",
                "InterventionDescription":"CAMS-informed psychotherapy",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "CAMS"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Number of repeated self-harming acts including suicide attempts (change in number of self-harming acts).",
                "PrimaryOutcomeDescription":"This information will be obtained as self-reported and through journal entries.How many acts how has taken place between the different time points in the trial (week 0, 17,28, and 52) to actually quantify the self-harming acts in order to find out if the treatment in the two arms can decrease the numbers of self-harming acts, also long term effect (week 52).",
                "PrimaryOutcomeTimeFrame":"Week 0 (baseline), 17, 28, 52."
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Depressive symptoms",
                "SecondaryOutcomeDescription":"Measured by HDRS-17 and BDI.",
                "SecondaryOutcomeTimeFrame":"Assessed at baseline, after treatment period (16 weeks), Week 28 and 52 after inclusion"
              },{
                "SecondaryOutcomeMeasure":"Impulsivity",
                "SecondaryOutcomeDescription":"Measured by Barratts Impulsivity Scale (BIS-11)",
                "SecondaryOutcomeTimeFrame":"Assessed at baseline, after treatment period (16 weeks), Week 28 and 52 after inclusion"
              },{
                "SecondaryOutcomeMeasure":"Consumptions of services in hospital care.",
                "SecondaryOutcomeDescription":"Register based information: Contact with hospital contact with code 4 (self-harm act), or suicide attemp X60-X84, or poisioning by weak analgesia (T39), hypnotics (T52), or psychothopic drugs (T43). Vital status, causes of death, use of bed days and outpatients services.",
                "SecondaryOutcomeTimeFrame":"After treatment period (16 weeks), Week 28 and 52 after inclusion"
              },{
                "SecondaryOutcomeMeasure":"Suicidal ideation",
                "SecondaryOutcomeDescription":"Measured by Beck's Suididal Ideation Scale (SSI-21)",
                "SecondaryOutcomeTimeFrame":"Assessed at baseline, after treatment period (16 weeks), Week 28 and 52 after inclusion"
              },{
                "SecondaryOutcomeMeasure":"Severity of borderline personality disorder symptoms.",
                "SecondaryOutcomeDescription":"Measured by Zanarini Borderline Personality Scale.",
                "SecondaryOutcomeTimeFrame":"Assessed at baseline, after treatment period (16 weeks), Week 28 and 52 after inclusion"
              },{
                "SecondaryOutcomeMeasure":"Anger",
                "SecondaryOutcomeDescription":"Measured by State Trait Anger Scale.",
                "SecondaryOutcomeTimeFrame":"Assessed at baseline, after treatment period (16 weeks), Week 28 and 52 after inclusion"
              },{
                "SecondaryOutcomeMeasure":"Hopelessness",
                "SecondaryOutcomeDescription":"Measured by Becks Hopelessness Scale.",
                "SecondaryOutcomeTimeFrame":"Assessed at baseline, after treatment period (16 weeks), Week 28 and 52 after inclusion."
              },{
                "SecondaryOutcomeMeasure":"Self Esteem",
                "SecondaryOutcomeDescription":"Measured by Rosenbergs Self esteem Scale (RSE).",
                "SecondaryOutcomeTimeFrame":"Assessed at baseline, after treatment period (16 weeks), Week 28 and 52 after inclusion"
              },{
                "SecondaryOutcomeMeasure":"Suicide related behavior.",
                "SecondaryOutcomeDescription":"Measured by Suicide Attempt Self Injury Interview (SASII) and Beck's suicide intent Scale",
                "SecondaryOutcomeTimeFrame":"Assessed at baseline, after treatment period (16 weeks), Week 28 and 52 after inclusion."
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\n18-65 years of age.\nNewly suicide attempt within one month of the inclusion date.\nA minimum of two characteristics in the DSM-IV Borderline Personality Disorder (BPD)\nInformed consent.\n\nExclusion Criteria:\n\nSevere depression.\nBipolar disorder.\nPsychosis within the schizophrenic spectrum.\nAnorexia Nervosa.\nSubstance abuse.\nMental retardation.\nDementia.\nLack of informed consent",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "MaximumAge":"65 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Mental Health Services, Research Unit, Bispebjerg",
                "LocationCity":"Copenhagen NV.",
                "LocationZip":"2400",
                "LocationCountry":"Denmark"
              }
            ]
          }
        },
        "ReferencesModule":{
          "ReferenceList":{
            "Reference":[
              {
                "ReferencePMID":"26854478",
                "ReferenceType":"derived",
                "ReferenceCitation":"Andreasson K, Krogh J, Wenneberg C, Jessen HK, Krakauer K, Gluud C, Thomsen RR, Randers L, Nordentoft M. EFFECTIVENESS OF DIALECTICAL BEHAVIOR THERAPY VERSUS COLLABORATIVE ASSESSMENT AND MANAGEMENT OF SUICIDALITY TREATMENT FOR REDUCTION OF SELF-HARM IN ADULTS WITH BORDERLINE PERSONALITY TRAITS AND DISORDER-A RANDOMIZED OBSERVER-BLINDED CLINICAL TRIAL. Depress Anxiety. 2016 Jun;33(6):520-30. doi: 10.1002/da.22472. Epub 2016 Feb 8."
              },{
                "ReferencePMID":"24885904",
                "ReferenceType":"derived",
                "ReferenceCitation":"Andreasson K, Krogh J, Rosenbaum B, Gluud C, Jobes DA, Nordentoft M. The DiaS trial: dialectical behavior therapy versus collaborative assessment and management of suicidality on self-harm in patients with a recent suicide attempt and borderline personality disorder traits - study protocol for a randomized controlled trial. Trials. 2014 May 29;15:194. doi: 10.1186/1745-6215-15-194."
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000013405",
                "ConditionMeshTerm":"Suicide"
              },{
                "ConditionMeshId":"D000010554",
                "ConditionMeshTerm":"Personality Disorders"
              },{
                "ConditionMeshId":"D000001883",
                "ConditionMeshTerm":"Borderline Personality Disorder"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000016728",
                "ConditionAncestorTerm":"Self-Injurious Behavior"
              },{
                "ConditionAncestorId":"D000001526",
                "ConditionAncestorTerm":"Behavioral Symptoms"
              },{
                "ConditionAncestorId":"D000001523",
                "ConditionAncestorTerm":"Mental Disorders"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M14774",
                "ConditionBrowseLeafName":"Suicide",
                "ConditionBrowseLeafAsFound":"Suicide",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M12045",
                "ConditionBrowseLeafName":"Personality Disorders",
                "ConditionBrowseLeafAsFound":"Personality Disorder",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M3743",
                "ConditionBrowseLeafName":"Borderline Personality Disorder",
                "ConditionBrowseLeafAsFound":"Borderline Personality Disorder",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M17672",
                "ConditionBrowseLeafName":"Self-Injurious Behavior",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M3399",
                "ConditionBrowseLeafName":"Behavioral Symptoms",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M3396",
                "ConditionBrowseLeafName":"Mental Disorders",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M13056",
                "ConditionBrowseLeafName":"Psychotic Disorders",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BXM",
                "ConditionBrowseBranchName":"Behaviors and Mental Disorders"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              }
            ]
          }
        }
      }
    }
  }
}