{
  "FullStudy":{
    "Rank":218016,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01513824",
          "OrgStudyIdInfo":{
            "OrgStudyId":"SongHeart"
          },
          "Organization":{
            "OrgFullName":"Herlev Hospital",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Stress and Ischemic Heart Disease. The Effect of Bio Feedback Guided Stress Management on Life Quality Including Signs of Depression and Stress",
          "OfficialTitle":"Stress, Ongoing Self Monitoring and Ischemic Heart Disease Rehabilitation, a Randomized Controlled Trial (SongHeart)",
          "Acronym":"SongHeart"
        },
        "StatusModule":{
          "StatusVerifiedDate":"February 2014",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"November 2011"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"February 2014",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"February 2014",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 17, 2012",
          "StudyFirstSubmitQCDate":"January 19, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 20, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"February 25, 2014",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"February 26, 2014",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Principal Investigator",
            "ResponsiblePartyInvestigatorFullName":"Jens Faber",
            "ResponsiblePartyInvestigatorTitle":"professor",
            "ResponsiblePartyInvestigatorAffiliation":"Herlev Hospital"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Herlev Hospital",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"Yes"
        },
        "DescriptionModule":{
          "BriefSummary":"The purpose of the study is to examine if bio feedback guided stress management by daily measurement of pressure pain sensitivity followed by acupressure reduces signs of depression and number clinical stress signs and increases quality of life in patients with stable, ischemic heart disease",
          "DetailedDescription":"Primary outcome Measure:\n\nMDI depression score (time frame 3 months) (designated as safety issue: no) The effect of 3 months twice daily measurements of Pressure Pain Sensitivity on the chest bone as a measure of the actual stress level followed by stress management of which Acupressure is mandatory\n\nSecondary outcome measures:\n\nClinical stress signs and quality of life measures (time frame 3 months) (designated as safety issue: no) The effect of 3 months twice daily measurements of Pressure Pain Sensitivity on the chest bone as a measure of the actual stress level followed by stress management of which Acupressure is mandatory, on a Clinical Stress Signs score (56 items), SF-36 and WHO-5 questionnaires\nMeasure of Pressure Pain Sensitivity by a professional (designated as safety issue: no) The effect of 3 months twice daily measurements of pressure pain sensitivity on the chest bone as a measure of the actual stress level followed by stress management of which acupressure is mandatory\nMeasures of heart function: Blood pressure, the Pressure-Pulse Product (heart work), Heart Rate Variability inclusive response to Tilting, BNP (time frame 3 months) (designated as safety issue: no) The effect of 3 months twice daily measurements of Pressure Pain Sensitivity on the chest bone as a measure of the actual stress level followed by stress management of which Acupressure is mandatory\nMeasures of the Metabolic Syndrome: HOMA-1, Adiponectin, HBA1C, Lipids, Body Composition (time frame 3 months) (designated as safety issue: no) The effect of 3 months twice daily measurements of Pressure Pain Sensitivity on the chest bone as a measure of the actual stress level followed by stress management of which Acupressure is mandatory\n\nTertiary outcome Measures:\n\nUse of health care (time frame one year after start of intervention) The effect of months twice daily measurements of Pressure Pain Sensitivity on the chest bone as a measure of the actual stress level followed by stress management of which Acupressure is mandatory, followed by 9 months bioguided feedback stress management when needed, i.e. post-study maintenance treatment"
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Biofeed Back Guided Stress Management",
              "Ischemic Heart Disease"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "stress",
              "biofeed back guided treatment",
              "acupressure",
              "ischemic heart disease"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Not Applicable"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Parallel Assignment",
            "DesignPrimaryPurpose":"Treatment",
            "DesignMaskingInfo":{
              "DesignMasking":"Single",
              "DesignWhoMaskedList":{
                "DesignWhoMasked":[
                  "Investigator"
                ]
              }
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"216",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"stress management, acupressure",
                "ArmGroupType":"Active Comparator",
                "ArmGroupDescription":"bio feedback guided stress management by daily measurement of pressure pain sensitivity followed by acupressure´for 3 months",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Behavioral: pressure pain sensitivity measure followed bu acupressure"
                  ]
                }
              },{
                "ArmGroupLabel":"bio feedback guided, stress management",
                "ArmGroupType":"No Intervention",
                "ArmGroupDescription":"control without treatment"
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Behavioral",
                "InterventionName":"pressure pain sensitivity measure followed bu acupressure",
                "InterventionDescription":"twice daily measure of pressure pain sensitivity on the chest bone followed by stress management of which acupressure is mandatory.",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "stress management, acupressure"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"MDI depression score",
                "PrimaryOutcomeDescription":"The effect of 3 months twice daily measurements of Pressure Pain Sensitivity on the chest bone as a measure of the actual stress level followed by stress management of which Acupressure is mandatory",
                "PrimaryOutcomeTimeFrame":"3 months"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Clinical stress signs and quality of life measures",
                "SecondaryOutcomeDescription":"The effect of 3 months twice daily measurements of Pressure Pain Sensitivity on the chest bone as a measure of the actual stress level followed by stress management of which Acupressure is mandatory, on a Clinical Stress Signs score (56 items), SF-36 and WHO-5 questionnaires",
                "SecondaryOutcomeTimeFrame":"3 months"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nPatients with documented stable, ischemic heart disease who have finished heart rehabilitation according to the National Guidelines > 6 months ago Actual use of aspirin, statins, and blood pressure medication according to the National Guidelines\nAge < 75 years\nIncreased pressure pain sensitivity ≥60 as a sign of persistent stress\n\nExclusion Criteria:\n\nPrevious diagnosed and treated psychiatric disease besides depression Other Chronic Disease with known significantly reduced life expectancy (as cancer or severe COPD)\nOther Chronic Disease with known significantly reduced Quality of Life as COPD, chronic pain conditions (but not diabetes or heart disease)\nPlanned heart operation\nChanged Medication for the Heart (concerning Angina or Heart Failure) within one month\nPrevious use of the Pressure Pain Sensitivity Device followed by treatment with Acupressure",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"19 Years",
          "MaximumAge":"75 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Department of Medicine, Herlev Hospital",
                "LocationCity":"Herlev",
                "LocationZip":"2730",
                "LocationCountry":"Denmark"
              }
            ]
          }
        },
        "ReferencesModule":{
          "ReferenceList":{
            "Reference":[
              {
                "ReferencePMID":"24849077",
                "ReferenceType":"derived",
                "ReferenceCitation":"Bergmann N, Ballegaard S, Bech P, Hjalmarson A, Krogh J, Gyntelberg F, Faber J. The effect of daily self-measurement of pressure pain sensitivity followed by acupressure on depression and quality of life versus treatment as usual in ischemic heart disease: a randomized clinical trial. PLoS One. 2014 May 21;9(5):e97553. doi: 10.1371/journal.pone.0097553. eCollection 2014."
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000006331",
                "ConditionMeshTerm":"Heart Diseases"
              },{
                "ConditionMeshId":"D000017202",
                "ConditionMeshTerm":"Myocardial Ischemia"
              },{
                "ConditionMeshId":"D000003324",
                "ConditionMeshTerm":"Coronary Artery Disease"
              },{
                "ConditionMeshId":"D000007511",
                "ConditionMeshTerm":"Ischemia"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000010335",
                "ConditionAncestorTerm":"Pathologic Processes"
              },{
                "ConditionAncestorId":"D000002318",
                "ConditionAncestorTerm":"Cardiovascular Diseases"
              },{
                "ConditionAncestorId":"D000014652",
                "ConditionAncestorTerm":"Vascular Diseases"
              },{
                "ConditionAncestorId":"D000003327",
                "ConditionAncestorTerm":"Coronary Disease"
              },{
                "ConditionAncestorId":"D000001161",
                "ConditionAncestorTerm":"Arteriosclerosis"
              },{
                "ConditionAncestorId":"D000001157",
                "ConditionAncestorTerm":"Arterial Occlusive Diseases"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M9126",
                "ConditionBrowseLeafName":"Ischemia",
                "ConditionBrowseLeafAsFound":"Ischemic",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M5641",
                "ConditionBrowseLeafName":"Depression",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M5129",
                "ConditionBrowseLeafName":"Coronary Artery Disease",
                "ConditionBrowseLeafAsFound":"Ischemic Heart Disease",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M5644",
                "ConditionBrowseLeafName":"Depressive Disorder",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M8002",
                "ConditionBrowseLeafName":"Heart Diseases",
                "ConditionBrowseLeafAsFound":"Heart Disease",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M18089",
                "ConditionBrowseLeafName":"Myocardial Ischemia",
                "ConditionBrowseLeafAsFound":"Ischemic Heart Disease",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M5132",
                "ConditionBrowseLeafName":"Coronary Disease",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M15983",
                "ConditionBrowseLeafName":"Vascular Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M3050",
                "ConditionBrowseLeafName":"Arteriosclerosis",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M3046",
                "ConditionBrowseLeafName":"Arterial Occlusive Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"T6054",
                "ConditionBrowseLeafName":"Quality of Life",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC23",
                "ConditionBrowseBranchName":"Symptoms and General Pathology"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"BXM",
                "ConditionBrowseBranchName":"Behaviors and Mental Disorders"
              },{
                "ConditionBrowseBranchAbbrev":"BC14",
                "ConditionBrowseBranchName":"Heart and Blood Diseases"
              }
            ]
          }
        }
      }
    }
  }
}