{ "FullStudy":{ "Rank":217649, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01518647", "OrgStudyIdInfo":{ "OrgStudyId":"M-20110265" }, "Organization":{ "OrgFullName":"University of Aarhus", "OrgClass":"OTHER" }, "BriefTitle":"Acceptance and Commitment Therapy for Patients With Multi-organ Bodily Distress Syndrome (Stress-4)", "OfficialTitle":"Treatment of Multi-organ Bodily Distress Syndrome. A Randomized Controlled Trial of the Effects of Acceptance and Commitment Therapy Given as Group Therapy or Workshop Compared to Standard Treatment (Stress-4)", "Acronym":"Stress-4" }, "StatusModule":{ "StatusVerifiedDate":"May 2017", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"January 25, 2012", "StartDateType":"Actual" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"August 25, 2015", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"February 9, 2016", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 13, 2012", "StudyFirstSubmitQCDate":"January 25, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 26, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"May 8, 2017", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"May 9, 2017", "LastUpdatePostDateType":"Actual" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"University of Aarhus", "LeadSponsorClass":"OTHER" } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"The aim of this study is to test the effect of Acceptance and Commitment Therapy (ACT) in patients with long lasting health problems with no known medical explanation, defined as multi-organ Bodily distress syndrome (BDS). ACT treatment is given as two different types of treatment, a 9-session group therapy and a 1-day workshop followed by an individual consultation, and both are compared to standard treatment, which is one single advisory consultation. The study includes 180 patients.", "DetailedDescription":"The aim of this study is to test the effect of Acceptance and Commitment Therapy (ACT) in patients with multi-organ Bodily distress syndrome (BDS). BDS is a unifying diagnosis that encompasses a group of closely related conditions such as somatization disorder, fibromyalgia, irritable bowel syndrome and chronic fatigue syndrome. The project consists of a three-armed randomized controlled trial of ACT treatment given as a supplement to standard treatment as either 9-session group therapy or as a 1-day workshop followed by an individual consultation, compared to standard treatment, which is one single advisory consultation.\n\nPrimary outcome is patient-rated improvement measured by Clinical Global Improvement Scale (CGI-I). Secondary outcome is functional level (physical, mental and social) measured by the SF-36 Physical Component Summary (PCS). The study includes 180 participants." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Somatisation Disorder", "Somatoform Disorders" ] }, "KeywordList":{ "Keyword":[ "Bodily Distress Syndrome", "Medically unexplained symptoms", "Functional somatic symptoms", "Functional somatic syndromes", "Treatment", "Acceptance and Commitment Therapy" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Not Applicable" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"180", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Group Therapy", "ArmGroupType":"Experimental", "ArmGroupDescription":"ACT given as conventional group therapy in groups of 7-8 patients 3,5 hours each session, 9 sessions during 3 month", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Behavioral: Acceptance and Commitment Therapy" ] } },{ "ArmGroupLabel":"Workshop", "ArmGroupType":"Experimental", "ArmGroupDescription":"ACT given as a one-day workshop with 15 patients with a following individual consultation", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Behavioral: Acceptance and Commitment Therapy" ] } },{ "ArmGroupLabel":"Standard treatment", "ArmGroupType":"Active Comparator", "ArmGroupDescription":"Standard treatment is one single advisory consultation given 2 weeks after randomization", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Behavioral: Acceptance and Commitment Therapy" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Behavioral", "InterventionName":"Acceptance and Commitment Therapy", "InterventionDescription":"Acceptance and Commitment Therapy is a new third wawe cognitive therapy with the key treatment elements: acceptance, personal values and goals", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Group Therapy", "Standard treatment", "Workshop" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Global Clinical Improvement Scale", "PrimaryOutcomeDescription":"Questionnaire, patient-rated improvement of health since the beginning of the study.", "PrimaryOutcomeTimeFrame":"14 month after randomization" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"SF-36", "SecondaryOutcomeDescription":"Questionnaire, patient-rated. Assessment of physical, social and mental functioning", "SecondaryOutcomeTimeFrame":"Before randomization, and at 6, 14 and 20 months after randomization" },{ "SecondaryOutcomeMeasure":"Visual Analogue Scale for pain and worst symptom", "SecondaryOutcomeTimeFrame":"Before randomization, and at 6, 14 and 20 month after randomization" },{ "SecondaryOutcomeMeasure":"Symptom Checklist (SCL)", "SecondaryOutcomeDescription":"Questionnaire, patient-rated. Assessment of physical, social and mental functioning", "SecondaryOutcomeTimeFrame":"Before randomization, and at 6, 14 and 20 month after randomization" },{ "SecondaryOutcomeMeasure":"WHODAS II", "SecondaryOutcomeDescription":"Questionnaire, patient-rated. Assessment of physical, social and mental functioning", "SecondaryOutcomeTimeFrame":"Before randomization, and at 6, 14 and 20 month after randomization" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nFirst time refered patients fulfilling diagnostic criteria for BDS multi-organ type with symptoms for more than 3 of 4 symptom categories\nModerate or severe impact on daily life\nSymptoms lasting for at least 2 years\nAge 20-50 years\nBorn in Denmark or have Danish parents. The patient understands, speaks, writes and read Danish.\n\nExclusion Criteria:\n\nPresence og other physical of psychiatric condition, if the symptoms of this condition can not clearly be separated from symptoms of BDS\nPatients with treatment demanding psychiatric disease as dominating problem\nA lifetime-diagnosis of psychoses, mania or depression with psychotic symptoms (ICD-10: F20-29, F30-31, F32.3, F33.3)\nAbuse of alcohol, narcotics or drugs\nPregnancy at time of inclusion", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"20 Years", "MaximumAge":"50 Years", "StdAgeList":{ "StdAge":[ "Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Johanne L Agger, MD", "OverallOfficialAffiliation":"Research Clinic for Functional Disorders, Aarhus University Hospital", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Research Clinic for Functional Disorders", "LocationCity":"Aarhus", "LocationZip":"8000", "LocationCountry":"Denmark" } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000004194", "ConditionMeshTerm":"Disease" },{ "ConditionMeshId":"D000013577", "ConditionMeshTerm":"Syndrome" },{ "ConditionMeshId":"D000013001", "ConditionMeshTerm":"Somatoform Disorders" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000010335", "ConditionAncestorTerm":"Pathologic Processes" },{ "ConditionAncestorId":"D000001523", "ConditionAncestorTerm":"Mental Disorders" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M14938", "ConditionBrowseLeafName":"Syndrome", "ConditionBrowseLeafAsFound":"Syndrome", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M885", "ConditionBrowseLeafName":"Medically Unexplained Symptoms", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M14386", "ConditionBrowseLeafName":"Somatoform Disorders", "ConditionBrowseLeafAsFound":"Somatoform Disorders", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M3396", "ConditionBrowseLeafName":"Mental Disorders", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M13056", "ConditionBrowseLeafName":"Psychotic Disorders", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC23", "ConditionBrowseBranchName":"Symptoms and General Pathology" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" },{ "ConditionBrowseBranchAbbrev":"BXM", "ConditionBrowseBranchName":"Behaviors and Mental Disorders" } ] } } } } } }