{
  "FullStudy":{
    "Rank":218301,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01510080",
          "OrgStudyIdInfo":{
            "OrgStudyId":"WECK-012"
          },
          "Organization":{
            "OrgFullName":"Goethe University",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Acceptance and Efficacy of Live Supervision",
          "OfficialTitle":"Live Supervision Put to Test - Studies of Acceptance and Efficacy of Computer-assisted Live Supervision"
        },
        "StatusModule":{
          "StatusVerifiedDate":"January 2015",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"January 2012"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"August 2014",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"August 2014",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"December 12, 2011",
          "StudyFirstSubmitQCDate":"January 10, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 13, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"January 19, 2015",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"January 21, 2015",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Principal Investigator",
            "ResponsiblePartyInvestigatorFullName":"Florian Weck",
            "ResponsiblePartyInvestigatorTitle":"Principal Investigator",
            "ResponsiblePartyInvestigatorAffiliation":"Goethe University"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Goethe University",
            "LeadSponsorClass":"OTHER"
          },
          "CollaboratorList":{
            "Collaborator":[
              {
                "CollaboratorName":"Central Institute of Mental Health, Mannheim",
                "CollaboratorClass":"OTHER"
              }
            ]
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"In order to meet an existing lack of empirical studies in the field of cognitive behavioral therapy supervision, the present randomized controlled trial is aimed at comparing two different types of supervision. This study compares computer-assisted live supervision and delayed video-based supervision regarding efficacy and acceptance among therapists, patients and supervisors. The efficacy of supervision is defined on different levels such as change of psychotherapeutic competence, nondisclosure, self-efficacy, self-awareness of the supervisee as well as therapeutic alliance, supervisory alliance and therapy outcome."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Mental Disorders"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "Computer-assisted live supervision",
              "\"Bug-in-the-eye\" supervision",
              "Delayed video-based supervision",
              "Cognitive behavioral therapy supervision"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Not Applicable"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Parallel Assignment",
            "DesignPrimaryPurpose":"Health Services Research",
            "DesignMaskingInfo":{
              "DesignMasking":"None (Open Label)"
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"42",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Computer-assisted live supervision",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"Supervisees assigned to this group will receive 8 sessions of computer-assisted live supervision and 4 sessions of delayed video-based supervision while treating 2 patients during 26 therapy sessions each. Computer-assisted live supervision is also known as \"bug-in-the-eye\" (BITE) supervision. The supervisor observes the therapy session with the help of a webcam and types messages on his computer. The instructions to the supervisee appear on a second monitor located in the therapy room where the supervisee can view it whenever he wants to.",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Behavioral: Computer-assisted live supervision"
                  ]
                }
              },{
                "ArmGroupLabel":"Delayed video-based supervision",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"Supervisees assigned to this group will receive 12 sessions of delayed video-based supervision while treating 2 patients during 26 therapy sessions each. During delayed video-based supervision the supervisor and the supervisee spend 50 minutes reviewing selected parts of video recorded therapy sessions and discussing the case.",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Behavioral: Delayed video-based supervision"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Behavioral",
                "InterventionName":"Computer-assisted live supervision",
                "InterventionDescription":"8 BITE sessions, 4 video-based sessions (each 50 minutes) during treatment of 2 patients",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Computer-assisted live supervision"
                  ]
                },
                "InterventionOtherNameList":{
                  "InterventionOtherName":[
                    "\"bug-in-the-eye\" (BITE) supervision",
                    "video-based live supervision",
                    "monitor-based live supervision"
                  ]
                }
              },{
                "InterventionType":"Behavioral",
                "InterventionName":"Delayed video-based supervision",
                "InterventionDescription":"12 video-based sessions (each 50 minutes) during treatment of 2 patients",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Delayed video-based supervision"
                  ]
                },
                "InterventionOtherNameList":{
                  "InterventionOtherName":[
                    "videotape supervision"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Supervisory Questionnaire (SQ)",
                "PrimaryOutcomeDescription":"self-report measure that assesses nondisclosure of the supervisee during supervision",
                "PrimaryOutcomeTimeFrame":"participants will be followed for the duration of psychotherapy, an expected average of 30 weeks"
              },{
                "PrimaryOutcomeMeasure":"Supervisee Levels Questionnaire (SLQ-R)",
                "PrimaryOutcomeDescription":"self-report measure that assesses self awareness, motivation and dependency- autonomy of supervisees",
                "PrimaryOutcomeTimeFrame":"participants will be followed for the duration of psychotherapy, an expected average of 30 weeks"
              },{
                "PrimaryOutcomeMeasure":"Counseling Self-Estimate Inventory (COSE)",
                "PrimaryOutcomeDescription":"self-report measure that assesses self efficacy of the supervisee",
                "PrimaryOutcomeTimeFrame":"participants will be followed for the duration of psychotherapy, an expected average of 30 weeks"
              },{
                "PrimaryOutcomeMeasure":"Fragebogen zur Psychotherapie-Supervision Kurzform (FSPT-K)",
                "PrimaryOutcomeDescription":"self-report measure that assesses level of development and supervision needs of the therapist",
                "PrimaryOutcomeTimeFrame":"participants will be followed for the duration of psychotherapy, an expected average of 30 weeks"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Helping Alliance Questionnaire (HAQ)",
                "SecondaryOutcomeDescription":"self-report measure that assesses the therapeutic alliance",
                "SecondaryOutcomeTimeFrame":"participants will be followed for the duration of psychotherapy, an expected average of 30 weeks"
              },{
                "SecondaryOutcomeMeasure":"Supervisory Working Alliance Inventory (SWAI)",
                "SecondaryOutcomeDescription":"self-report measure that assesses the supervisory relationship",
                "SecondaryOutcomeTimeFrame":"participants will be followed for the duration of psychotherapy, an expected average of 30 weeks"
              },{
                "SecondaryOutcomeMeasure":"Beck-Depression Inventory II (BDI-II)",
                "SecondaryOutcomeDescription":"self-report measure that assesses depressive symptoms",
                "SecondaryOutcomeTimeFrame":"participants will be followed for the duration of psychotherapy, an expected average of 30 weeks"
              },{
                "SecondaryOutcomeMeasure":"Beck Anxiety Inventory II (BAI)",
                "SecondaryOutcomeDescription":"self-report measure that asessses anxiety symptoms",
                "SecondaryOutcomeTimeFrame":"participants will be followed for the duration of psychotherapy, an expected average of 30 weeks"
              },{
                "SecondaryOutcomeMeasure":"Brief Symptom Inventory (BSI)",
                "SecondaryOutcomeDescription":"self-report measure that assesses aspects of general psychopathology",
                "SecondaryOutcomeTimeFrame":"participants will be followed for the duration of psychotherapy, an expected average of 30 weeks"
              },{
                "SecondaryOutcomeMeasure":"Health-related quality of life (SF-12)",
                "SecondaryOutcomeDescription":"self-report measure that assesses the health-related quality of life",
                "SecondaryOutcomeTimeFrame":"participants will be followed for the duration of psychotherapy, an expected average of 30 weeks"
              },{
                "SecondaryOutcomeMeasure":"Client Satisfaction Questionnaire (CSQ8)",
                "SecondaryOutcomeDescription":"self-report measure that assesses satisfaction with therapy",
                "SecondaryOutcomeTimeFrame":"participants will be followed for the duration of psychotherapy, an expected average of 30 weeks"
              },{
                "SecondaryOutcomeMeasure":"Stundenbogen zur Supervisionsbeurteilung (STEP SV)",
                "SecondaryOutcomeDescription":"self-report measure that assesses satisfaction with supervision",
                "SecondaryOutcomeTimeFrame":"participants will be followed for the duration of psychotherapy, an expected average of 30 weeks"
              },{
                "SecondaryOutcomeMeasure":"Cognitive Therapy Scale (CTS)",
                "SecondaryOutcomeDescription":"clinician-rated measure that assesses psychotherapeutic competencies",
                "SecondaryOutcomeTimeFrame":"participants will be followed for the duration of psychotherapy, an expected average of 30 weeks"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Supervisees\n\nInclusion Criteria:\n\nHaving successfully completed the interim audit\nHaving started to treat ambulant patients under supervision\n\nExclusion Criteria:\n\n-\n\nPatients\n\nInclusion Criteria:\n\nMeeting ICD 10 criteria for a mental disorder\nInformed consent\n\nExclusion Criteria:\n\nCurrently in psychotherapy\nSuicidal tendency\nClinical diagnosis of alcohol or drug addiction, acute schizophrenia, schizoaffective disorder or bipolar disorder",
          "HealthyVolunteers":"Accepts Healthy Volunteers",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "MaximumAge":"65 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Florian Weck, PhD",
                "OverallOfficialAffiliation":"Goethe University",
                "OverallOfficialRole":"Principal Investigator"
              },{
                "OverallOfficialName":"Martin Bohus, MD",
                "OverallOfficialAffiliation":"Central Institute of Mental Health",
                "OverallOfficialRole":"Study Director"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Department of Clinical Psychology and Psychotherapy of the Wolfgang Goethe University",
                "LocationCity":"Frankfurt",
                "LocationState":"Hessen",
                "LocationZip":"D-60486",
                "LocationCountry":"Germany"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000001523",
                "ConditionMeshTerm":"Mental Disorders"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M3396",
                "ConditionBrowseLeafName":"Mental Disorders",
                "ConditionBrowseLeafAsFound":"Mental Disorders",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M13056",
                "ConditionBrowseLeafName":"Psychotic Disorders",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BXM",
                "ConditionBrowseBranchName":"Behaviors and Mental Disorders"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              }
            ]
          }
        }
      }
    }
  }
}