Nctid:
NCT06230809
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D005715", "term"=>"Gambling"}], "ancestors"=>[{"id"=>"D007174", "term"=>"Disruptive, Impulse Control, and Conduct Disorders"}, {"id"=>"D001523", "term"=>"Mental Disorders"}], "browseLeaves"=>[{"id"=>"M8832", "name"=>"Gambling", "asFound"=>"Gambling", "relevance"=>"HIGH"}, {"id"=>"M10219", "name"=>"Disruptive, Impulse Control, and Conduct Disorders", "relevance"=>"LOW"}, {"id"=>"M21827", "name"=>"Conduct Disorder", "relevance"=>"LOW"}, {"id"=>"M14473", "name"=>"Psychotic Disorders", "relevance"=>"LOW"}, {"id"=>"M4815", "name"=>"Mental Disorders", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Behaviors and Mental Disorders", "abbrev"=>"BXM"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"SUPPORTIVE_CARE", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>170}}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-03-01", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2025-06-01", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-01-25", "studyFirstSubmitDate"=>"2023-10-02", "studyFirstSubmitQcDate"=>"2024-01-25", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-30", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-30", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-12-31", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Kessler-9", "timeFrame"=>"At baseline and post treatment (5-7 weeks after inclusion) and again 3, 6, and 12 months following treatment completion", "description"=>"Mental health"}], "secondaryOutcomes"=>[{"measure"=>"Patient Health Questionnaire-9", "timeFrame"=>"At baseline and post treatment (5-7 weeks after baseline) and again 3, 6, and 12 months following treatment completion", "description"=>"Depressive symptoms"}, {"measure"=>"Generalized Anxiety Disorder 7-item scale", "timeFrame"=>"At baseline and post treatment (5-7 weeks after inclusion), and again 3, 6, and 12 months following treatment completion", "description"=>"Anxiety symptoms"}, {"measure"=>"Relationship Assessment Scale", "timeFrame"=>"At baseline and post treatment (5-7 weeks after inclusion), and again 3, 6, and 12 months following treatment completion", "description"=>"Relationship satisfaction"}, {"measure"=>"Family Member Impact Scale", "timeFrame"=>"At baseline and post treatment (5-7 weeks after inclusion), and again 3, 6, and 12 months following treatment completion", "description"=>"Gambling-related family stress"}, {"measure"=>"Coping Questionnaire", "timeFrame"=>"At baseline and post treatment (5-7 weeks after inclusion), and again 3, 6, and 12 months following treatment completion", "description"=>"Coping"}, {"measure"=>"Brunnsviken Brief Quality of life quality scale", "timeFrame"=>"At baseline and post treatment (5-7 weeks after inclusion), and again 3, 6, and 12 months following treatment completion", "description"=>"Quality of life"}]}, "oversightModule"=>{"isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["concerned significant others"], "conditions"=>["Problem Gambling"]}, "descriptionModule"=>{"briefSummary"=>"The project aims to evaluate a brief online self-help intervention for Concerned Significant Others of individuals with Problem Gambling. The intervention consists of five modules with texts, films and exercises and is compared to a waiting list."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* No treatment related to the gambling during the past 3 months for the CSO\n* The CSO is at least 18 years old\n* The CSO can read and answer questions in Swedish.\n* The CSO is assessed as a non-problem gambler according to the Gambling Disorder Identification Test.\n\nExclusion Criteria:\n\n* Displaying symptoms of severe psychiatric disorders such as psychosis or bipolar disease deemed to needed other treatment options."}, "identificationModule"=>{"nctId"=>"NCT06230809", "briefTitle"=>"Internet Based Self-help for Problem Gambling Concerned Significant Others", "organization"=>{"class"=>"OTHER", "fullName"=>"Karolinska Institutet"}, "officialTitle"=>"Internet Based Self-help for Problem Gambling Concerned Significant Others", "orgStudyIdInfo"=>{"id"=>"2023-04225-01"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Intervention", "interventionNames"=>["Behavioral: Web-based self-help"]}, {"type"=>"NO_INTERVENTION", "label"=>"Waitlist", "description"=>"Waitlist, participants will be included after 8 weeks."}], "interventions"=>[{"name"=>"Web-based self-help", "type"=>"BEHAVIORAL", "description"=>"Web-based self-help with 5 modules, lasting 5 weeks.", "armGroupLabels"=>["Intervention"]}]}, "contactsLocationsModule"=>{"centralContacts"=>[{"name"=>"Anders Nilsson", "role"=>"CONTACT", "email"=>"anders.nilsson.2@ki.se", "phone"=>"+46702235492"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"YES", "description"=>"IPD will be shared upon reasonable request."}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Karolinska Institutet", "class"=>"OTHER"}, "collaborators"=>[{"name"=>"The National Gambling Helpline Sweden", "class"=>"UNKNOWN"}], "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"PhD", "investigatorFullName"=>"Anders Nilsson", "investigatorAffiliation"=>"Karolinska Institutet"}}}}
