{
  "FullStudy":{
    "Rank":217736,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01517503",
          "OrgStudyIdInfo":{
            "OrgStudyId":"METC 10/103"
          },
          "Organization":{
            "OrgFullName":"VU University of Amsterdam",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Acceptance and Commitment Therapy Versus Cognitive Therapy for the Treatment of Major Depressive Disorder",
          "OfficialTitle":"Acceptance and Commitment Therapy vs. Cognitive Therapy for the Treatment of Major Depressive Disorder"
        },
        "StatusModule":{
          "StatusVerifiedDate":"July 2019",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"December 2011"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"August 2015",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"August 2015",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"November 8, 2011",
          "StudyFirstSubmitQCDate":"January 20, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 25, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"July 26, 2019",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"July 30, 2019",
            "LastUpdatePostDateType":"Actual"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Principal Investigator",
            "ResponsiblePartyInvestigatorFullName":"Paul M.G.Emmelkamp",
            "ResponsiblePartyInvestigatorTitle":"Professor",
            "ResponsiblePartyInvestigatorAffiliation":"VU University of Amsterdam"
          },
          "LeadSponsor":{
            "LeadSponsorName":"VU University of Amsterdam",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"Yes"
        },
        "DescriptionModule":{
          "BriefSummary":"The study will investigate the effectiveness of Cognitive Therapy and Acceptance and Commitment Therapy in a randomized controlled trial among patients with Major Depressive Disorder in routine clinical practice. Furthermore, the study will investigate whether each specific treatment approach is mediated by its proposed theoretical mechanism.",
          "DetailedDescription":"The current study aims at investigating the effectiveness of Cognitive Therapy and Acceptance and Commitment Therapy in a randomized controlled trial among patients with MDD in routine clinical practice. Further, the study will investigate whether each specific treatment approach is mediated by its proposed theoretical mechanism. Patients have to meet diagnostic criteria for nonpsychotic MDD as determined by the Structured Interview for DSM-IV. Each client will receive either Cognitive Therapy or Acceptance and Commitment Therapy that will last between 16 to 20 sessions. Based on previous results, it is expected that both treatment forms will prove beneficial for the patients."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Major Depressive Disorder"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Not Applicable"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Parallel Assignment",
            "DesignPrimaryPurpose":"Treatment",
            "DesignMaskingInfo":{
              "DesignMasking":"Single",
              "DesignWhoMaskedList":{
                "DesignWhoMasked":[
                  "Outcomes Assessor"
                ]
              }
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"82",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Cognitive Therapy (CT)",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"Cognitive Therapy (CT)",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Behavioral: Cognitive Therapy"
                  ]
                }
              },{
                "ArmGroupLabel":"Acceptance and Commitment Therapy (ACT)",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"Acceptance and Commitment Therapy (ACT)",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Behavioral: Acceptance and Commitment Therapy"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Behavioral",
                "InterventionName":"Cognitive Therapy",
                "InterventionDescription":"This interventions will target: (a) behavioral dysfunction, (b) situation-specific negative thinking and cognitive distortions, and (c) underlying dysfunctional beliefs or cognitions assumed to be related to the patient's current depression and risk of future depression. A maximum of 20 45-55 minute sessions will be provided, with sessions generally held weekly for the first 8 sessions and once every two weeks for the next 8 sessions.",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Cognitive Therapy (CT)"
                  ]
                },
                "InterventionOtherNameList":{
                  "InterventionOtherName":[
                    "Cognitive behavior therapy; cognitive behaviour therapy."
                  ]
                }
              },{
                "InterventionType":"Behavioral",
                "InterventionName":"Acceptance and Commitment Therapy",
                "InterventionDescription":"This interventions will use (a) acceptance, (b) commitment, (c) mindfulness, and (d) behavior change processes to produce reduction of depressive symptoms. A maximum of 20 45-55 minute sessions will be provided, with sessions generally held weekly for the first 8 sessions and once every two weeks for the next 8 sessions.",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Acceptance and Commitment Therapy (ACT)"
                  ]
                },
                "InterventionOtherNameList":{
                  "InterventionOtherName":[
                    "Mindfulness-based interventions"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"QUICK INVENTORY OF DEPRESSIVE SYMPTOMATOLOGY (QIDS-SR)",
                "PrimaryOutcomeDescription":"Change from pre-treatment to post-treatment, 6 months follow-up and 12 months follow-up",
                "PrimaryOutcomeTimeFrame":"pre-treatment, post-treatment, 6 and 12 months follow-up"
              },{
                "PrimaryOutcomeMeasure":"Hamilton Rating Scale for Depression",
                "PrimaryOutcomeDescription":"Change from pre-treatment to post-treatment.",
                "PrimaryOutcomeTimeFrame":"pre-treatment, post-treatment"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Decentering subscale of the Experiences Questionnaire",
                "SecondaryOutcomeDescription":"Change between sessions and to follow-up.",
                "SecondaryOutcomeTimeFrame":"Pre-treatment, in-treatment, and 6 and 12 months follow-up."
              },{
                "SecondaryOutcomeMeasure":"Acceptance and Action Questionnaire",
                "SecondaryOutcomeDescription":"Change between sessions and to follow-up.",
                "SecondaryOutcomeTimeFrame":"Pre-treatment, in-treatment, and 6 and 12 months follow-up."
              },{
                "SecondaryOutcomeMeasure":"Dysfunctional Attitude Scale-revised",
                "SecondaryOutcomeDescription":"Change between sessions to follow-up.",
                "SecondaryOutcomeTimeFrame":"Pre-treatment, in-treatment, and 6 and 12 months follow-up"
              },{
                "SecondaryOutcomeMeasure":"Working Alliance Inventory",
                "SecondaryOutcomeTimeFrame":"3. session"
              },{
                "SecondaryOutcomeMeasure":"Eurohis Quality of Life Scale",
                "SecondaryOutcomeDescription":"Change pre-treatment to post-treatment and to follow-up.",
                "SecondaryOutcomeTimeFrame":"Pre-, post-treatment, 6 and 12 months follow-up"
              },{
                "SecondaryOutcomeMeasure":"Relationship Scales",
                "SecondaryOutcomeDescription":"Change pre-treatment to post-treatment and to follow-up.",
                "SecondaryOutcomeTimeFrame":"Pre-, post-treatment, 12 months follow-up"
              },{
                "SecondaryOutcomeMeasure":"Implicit Attitude Test",
                "SecondaryOutcomeDescription":"Change pre-treatment to post-treatment",
                "SecondaryOutcomeTimeFrame":"Pre- and posttreatment"
              },{
                "SecondaryOutcomeMeasure":"Structured Clinical Interview for DSM-IV (Major Depression Module)",
                "SecondaryOutcomeDescription":"Change in diagnosis of Major Depression Disorder from pre-treatment to post-treatment.",
                "SecondaryOutcomeTimeFrame":"Pre-treatment and post-treatment."
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nMeeting DSM-IV criteria for MDD\nBetween the ages of 18 and 65-years-old\nHaving sufficient fluency in Dutch to complete treatment and research protocol\n\nExclusion Criteria:\n\nDSM-IV criteria for bipolar disorder (past or present)\nPsychotic disorders\nSubstance dependence disorders (current or within the past 6 months), or\nOrganic brain syndrome.\nBorderline or antisocial personality disorder",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "MaximumAge":"65 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Paul MG Emmelkamp, PhD",
                "OverallOfficialAffiliation":"University of Amsterdam",
                "OverallOfficialRole":"Principal Investigator"
              },{
                "OverallOfficialName":"Nexhmedin Morina, PhD",
                "OverallOfficialAffiliation":"University of Amsterdam",
                "OverallOfficialRole":"Study Director"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"PsyQ",
                "LocationCity":"Zaandam",
                "LocationZip":"1500 AE",
                "LocationCountry":"Netherlands"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000003866",
                "ConditionMeshTerm":"Depressive Disorder"
              },{
                "ConditionMeshId":"D000003863",
                "ConditionMeshTerm":"Depression"
              },{
                "ConditionMeshId":"D000003865",
                "ConditionMeshTerm":"Depressive Disorder, Major"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000019964",
                "ConditionAncestorTerm":"Mood Disorders"
              },{
                "ConditionAncestorId":"D000001523",
                "ConditionAncestorTerm":"Mental Disorders"
              },{
                "ConditionAncestorId":"D000001526",
                "ConditionAncestorTerm":"Behavioral Symptoms"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M5641",
                "ConditionBrowseLeafName":"Depression",
                "ConditionBrowseLeafAsFound":"Depressive Disorder",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M5644",
                "ConditionBrowseLeafName":"Depressive Disorder",
                "ConditionBrowseLeafAsFound":"Depressive Disorder",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M5643",
                "ConditionBrowseLeafName":"Depressive Disorder, Major",
                "ConditionBrowseLeafAsFound":"Major Depressive Disorder",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M20419",
                "ConditionBrowseLeafName":"Mood Disorders",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M3396",
                "ConditionBrowseLeafName":"Mental Disorders",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M13056",
                "ConditionBrowseLeafName":"Psychotic Disorders",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M3399",
                "ConditionBrowseLeafName":"Behavioral Symptoms",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BXM",
                "ConditionBrowseBranchName":"Behaviors and Mental Disorders"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              }
            ]
          }
        }
      }
    }
  }
}