{ "FullStudy":{ "Rank":218202, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01511406", "OrgStudyIdInfo":{ "OrgStudyId":"CBT2011" }, "Organization":{ "OrgFullName":"Oslo University Hospital", "OrgClass":"OTHER" }, "BriefTitle":"Cognitive Behavioral Therapy for Patients With an Early Psychosis", "OfficialTitle":"Does Cognitive Behavioral Therapy Improve Depressive Symptoms and Self-Esteem in Patients With a First Episode Psychosis? A Randomized Controlled Study" }, "StatusModule":{ "StatusVerifiedDate":"October 2014", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"January 2011" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"October 2014", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"October 2014", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"December 27, 2011", "StudyFirstSubmitQCDate":"January 17, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 18, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"October 22, 2014", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"October 23, 2014", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Oslo University Hospital", "LeadSponsorClass":"OTHER" }, "CollaboratorList":{ "Collaborator":[ { "CollaboratorName":"Stiftelsen Helse og Rehabilitering", "CollaboratorClass":"OTHER" } ] } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"The purpose of the present study is to examine whether cognitive behavior therapy will reduce depressive symptoms and increase self-esteem for patients with a first episode psychosis.", "DetailedDescription":"A growing body of evidence supports the use of Cognitive Behavioural Therapy (CBT) for the treatment of schizophrenia. The strength of evidence is especially strong for patients with persistent hallucinations and delusions. As it comes to the effect of CBT for patients with a first episode psychosis the picture is more unclear. The main reason is probably that the CBT interventions to a less extent have been adjusted to fit first episode psychosis patients. The main problems for patients with a first episode psychosis (FEP) is rarely persistent hallucinations and delusions but they struggle with social anxiety, depression, alcohol and drug abuse and low self esteem. Forthcoming studies examining the effect of CBT for patients with a first episode psychosis should aim to have a focus on these symptoms.\n\nThe main aim of the present study is to examine whether CBT has any effect on depressive symptoms and self-esteem in patients with a FEP.\n\nThe study will include patients with a first episode psychosis with Axis-I DSM IV diagnosis of schizophrenia, schizoaffective disorder, delusional disorder, and psychosis not otherwise specified. To be included in the study the patients should meet the criteria of an affective episode the last year or have a score on Calgary Depression of Schizophrenia Scale above four. Patients are randomly selected to either a treatment group or a control (placebo) group. The aim is to include 30 patients in each group. Patients in the treatment group will receive a manual-based CBT intervention comprising up to 26 sessions during a six months period. The control group will receive treatment as usual (TAU).\n\nThe patients are assessed before the entry of the study and after 6 months (end of treatment). Moreover they will be assessed after 9 months of ending therapy.\n\nHypothesis:\n\nIn this study we hypothesize that\n\npatients receiving CBT will have less depressive symptoms than TAU-patients at the and of treatment and at six months follow up\nCBT-patients will demonstrate a better improvement in their self-esteem than TAU-patients at the end of treatment and at six months follow up.\n\nTo our knowledge, no previous studies have examined outcome after CBT treatment with regards to depressive symptoms and self-esteem. Furthermore, this is the first randomized controlled study in Norway of CBT among patients with a FEP." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Psychosis", "Schizophrenia", "Depressive Symptoms", "Self-esteem" ] }, "KeywordList":{ "Keyword":[ "Psychosis", "Schizophrenia", "Cognitive behavioral therapy", "Self esteem", "Depression" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 2" ] }, "DesignInfo":{ "DesignInterventionModel":"Single Group Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"Single", "DesignWhoMaskedList":{ "DesignWhoMasked":[ "Outcomes Assessor" ] } } }, "EnrollmentInfo":{ "EnrollmentCount":"60", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"cognitive behavioral therapy", "ArmGroupType":"Experimental", "ArmGroupDescription":"Cognitive behavioral therapy up to 26 sessions", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Behavioral: cognitive behavioral therapy" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Behavioral", "InterventionName":"cognitive behavioral therapy", "InterventionDescription":"Patients allocated to the treatment arm will receive up to 26 sessions of cognitive behavioral therapy", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "cognitive behavioral therapy" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "CBT" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Calgary Depression rating Scale for Schizophrenia (CDSS)", "PrimaryOutcomeDescription":"Measure depressive symptoms for patients with a psychosis", "PrimaryOutcomeTimeFrame":"up to nine months after end of intervention" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Rosenberg Self Esteem Scale", "SecondaryOutcomeDescription":"Measure the level of self esteem among patients with a psychosis", "SecondaryOutcomeTimeFrame":"up to nine months after end of intervention" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nParticipants are eligible for the study if they are diagnosed with a psychotic disorder or bipolar disorder with psychosis according to DSM-IV (i.e. schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder or psychosis NOS\nAged between 18-65 years\nAre capable of giving a written consent to participate in the study.\n\nExclusion Criteria:\n\nA history of head injury, neurological disorders, developmental disorders, and all episodes of psychosis being judged as substance-induced rather than a primary episode of a psychotic disorder.\nBeing in treatment for more than five years", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"18 Years", "MaximumAge":"65 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Jan I Røssberg, MD, PhD", "OverallOfficialAffiliation":"Oslo University Hospital", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Oslo University Hospital", "LocationCity":"Oslo", "LocationZip":"0407", "LocationCountry":"Norway" } ] } }, "ReferencesModule":{ "ReferenceList":{ "Reference":[ { "ReferencePMID":"31935529", "ReferenceType":"derived", "ReferenceCitation":"Sönmez N, Romm KL, Østefjells T, Grande M, Jensen LH, Hummelen B, Tesli M, Melle I, Røssberg JI. Cognitive behavior therapy in early psychosis with a focus on depression and low self-esteem: A randomized controlled trial. Compr Psychiatry. 2020 Feb;97:152157. doi: 10.1016/j.comppsych.2019.152157. Epub 2019 Dec 26." } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000012559", "ConditionMeshTerm":"Schizophrenia" },{ "ConditionMeshId":"D000011618", "ConditionMeshTerm":"Psychotic Disorders" },{ "ConditionMeshId":"D000001523", "ConditionMeshTerm":"Mental Disorders" },{ "ConditionMeshId":"D000003863", "ConditionMeshTerm":"Depression" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000019967", "ConditionAncestorTerm":"Schizophrenia Spectrum and Other Psychotic Disorders" },{ "ConditionAncestorId":"D000001526", "ConditionAncestorTerm":"Behavioral Symptoms" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M3396", "ConditionBrowseLeafName":"Mental Disorders", "ConditionBrowseLeafAsFound":"Psychosis", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M5641", "ConditionBrowseLeafName":"Depression", "ConditionBrowseLeafAsFound":"Depressive Symptoms", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M5644", "ConditionBrowseLeafName":"Depressive Disorder", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M13959", "ConditionBrowseLeafName":"Schizophrenia", "ConditionBrowseLeafAsFound":"Schizophrenia", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M13056", "ConditionBrowseLeafName":"Psychotic Disorders", "ConditionBrowseLeafAsFound":"Psychosis", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M20422", "ConditionBrowseLeafName":"Schizophrenia Spectrum and Other 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" } ] } } } } } }