Nctid:
NCT00000370
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-17"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000010698", "term"=>"Phobic Disorders"}, {"id"=>"D000072861", "term"=>"Phobia, Social"}], "ancestors"=>[{"id"=>"D000001008", "term"=>"Anxiety Disorders"}, {"id"=>"D000001523", "term"=>"Mental Disorders"}], "browseLeaves"=>[{"id"=>"M4324", "name"=>"Anxiety Disorders", "relevance"=>"LOW"}, {"id"=>"M1117", "name"=>"Phobia, Social", "asFound"=>"Social Phobia", "relevance"=>"HIGH"}, {"id"=>"M13603", "name"=>"Phobic Disorders", "asFound"=>"Phobic Disorders", "relevance"=>"HIGH"}, {"id"=>"M4815", "name"=>"Mental Disorders", "relevance"=>"LOW"}, {"id"=>"M14473", "name"=>"Psychotic Disorders", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Behaviors and Mental Disorders", "abbrev"=>"BXM"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"primaryPurpose"=>"TREATMENT"}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"1998-05"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2018-01", "completionDateStruct"=>{"date"=>"2003-02"}, "lastUpdateSubmitDate"=>"2018-01-16", "studyFirstSubmitDate"=>"1999-11-02", "studyFirstSubmitQcDate"=>"1999-11-02", "lastUpdatePostDateStruct"=>{"date"=>"2018-01-18", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"1999-11-03", "type"=>"ESTIMATED"}}, "conditionsModule"=>{"keywords"=>["Cognitive Therapy", "Cost of Illness", "Female", "Human", "Male", "Phobic Disorders", "Phobic Disorders -- *therapy", "Phobic Disorders -- pathology"], "conditions"=>["Phobic Disorders", "Social Phobia", "Public Speaking Anxiety"]}, "descriptionModule"=>{"briefSummary"=>"Social phobia is a very common and debilitating disorder, with public speaking anxiety being the most common fear. Psychologists have found that treating patients for their fear of public speaking, through cognitive-behavioral treatment (talk-based therapy) or exposure treatment (where participants participate in actual public speaking sessions), not only helps patients overcome this fear but also helps them overcome their more general social fears. However, little is known about how this change occurs during therapy. This study tries to identify the factors that contribute most to successful therapy.\n\nPatients are assigned randomly (like tossing a coin) to 1 of 3 groups. Group 1 will receive cognitive-behavioral treatment and Group 2 will receive exposure treatment. Group 3 will not receive treatment. Study leaders will monitor patient response to treatment through behavioral tests and assessments.\n\nAn individual may be eligible for this study if he/she:\n\nHas social phobia with public speaking anxiety.", "detailedDescription"=>"The primary goal of the present study is to identify the mediators and moderators of change in the treatment of social phobia and, in so doing suggest a common mechanism of action for all brief psychosocial interventions. Perceived self-efficacy of social behavior, negative cognitive appraisal (estimated social costs), and perceived emotional control will be considered as potential mediators; avoidant personality disorder and the generalized subtype of social phobia will be considered as potential predictors for poor treatment outcome.\n\nSocial phobia is a very prevalent and debilitating disorder, with public speaking anxiety being the most common fear among socially phobic individuals. Although there are a number of effective psychosocial treatments for social phobia (e.g., cognitive-behavioral treatments and exposure therapy) very little is known about the underlying mechanism of therapeutic change (i.e., the mediators of change), and the variables that are predictive of treatment outcome (i.e., the moderators of change). Furthermore, it is unclear why treating individuals for their public speaking anxiety can generalize to other untreated social fears.\n\nPatients are randomly assigned to either a comprehensive cognitive-behavioral treatment for social phobia (n=43), a performance-based exposure treatment for public speaking anxiety without cognitive intervention (n=43), or a waitlist control group (n=43). Clinician ratings, behavioral tests, cognitive assessments, subjective ratings, and physiological measures are employed to determine the degree of therapeutic gains in various social phobia domains. The main hypothesis is that perceived emotional control will mediate treatment outcome and generality of effectiveness independent of the specific treatment condition."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n-\n\nPatients must have:\n\nSocial phobia with public speaking anxiety."}, "identificationModule"=>{"nctId"=>"NCT00000370", "briefTitle"=>"Treatment of Social Phobia", "organization"=>{"class"=>"OTHER", "fullName"=>"Boston University Charles River Campus"}, "officialTitle"=>"Treatment of Social Phobia: Mediators And Moderators", "orgStudyIdInfo"=>{"id"=>"R29MH057326", "link"=>"https://reporter.nih.gov/quickSearch/R29MH057326", "type"=>"NIH"}, "secondaryIdInfos"=>[{"id"=>"R29MH057326", "link"=>"https://reporter.nih.gov/quickSearch/R29MH057326", "type"=>"NIH"}, {"id"=>"DSIR AT-AS"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Cognitive behavior therapy", "type"=>"BEHAVIORAL"}, {"name"=>"Performance-based exposure therapy", "type"=>"BEHAVIORAL"}, {"name"=>"Psychosocial intervention", "type"=>"BEHAVIORAL"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"02215", "city"=>"Boston", "state"=>"Massachusetts", "country"=>"United States", "facility"=>"Center for Anxiety and Related Disorders at Boston University", "geoPoint"=>{"lat"=>42.35843, "lon"=>-71.05977}}], "overallOfficials"=>[{"name"=>"Stefan Hofmann, PhD", "role"=>"PRINCIPAL_INVESTIGATOR"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Boston University Charles River Campus", "class"=>"OTHER"}, "collaborators"=>[{"name"=>"National Institute of Mental Health (NIMH)", "class"=>"NIH"}], "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Professor of Psychology", "investigatorFullName"=>"Stefan G. Hofmann", "investigatorAffiliation"=>"Boston University Charles River Campus"}}}}
