Nctid:
NCT06617143
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000001249", "term"=>"Asthma"}, {"id"=>"D000004417", "term"=>"Dyspnea"}, {"id"=>"D000003863", "term"=>"Depression"}], "ancestors"=>[{"id"=>"D000001526", "term"=>"Behavioral Symptoms"}, {"id"=>"D000001982", "term"=>"Bronchial Diseases"}, {"id"=>"D000012140", "term"=>"Respiratory Tract Diseases"}, {"id"=>"D000008173", "term"=>"Lung Diseases, Obstructive"}, {"id"=>"D000008171", "term"=>"Lung Diseases"}, {"id"=>"D000012130", "term"=>"Respiratory Hypersensitivity"}, {"id"=>"D000006969", "term"=>"Hypersensitivity, Immediate"}, {"id"=>"D000006967", "term"=>"Hypersensitivity"}, {"id"=>"D000007154", "term"=>"Immune System Diseases"}, {"id"=>"D000012120", "term"=>"Respiration Disorders"}, {"id"=>"D000012818", "term"=>"Signs and Symptoms, Respiratory"}], "browseLeaves"=>[{"id"=>"M7058", "name"=>"Depression", "asFound"=>"Depression", "relevance"=>"HIGH"}, {"id"=>"M7061", "name"=>"Depressive Disorder", "relevance"=>"LOW"}, {"id"=>"M4324", "name"=>"Anxiety Disorders", "relevance"=>"LOW"}, {"id"=>"M4556", "name"=>"Asthma", "asFound"=>"Asthma", "relevance"=>"HIGH"}, {"id"=>"M7591", "name"=>"Dyspnea", "asFound"=>"Dyspnea", "relevance"=>"HIGH"}, {"id"=>"M4818", "name"=>"Behavioral Symptoms", "relevance"=>"LOW"}, {"id"=>"M5258", "name"=>"Bronchial Diseases", "relevance"=>"LOW"}, {"id"=>"M14977", "name"=>"Respiratory Tract Diseases", "relevance"=>"LOW"}, {"id"=>"M11168", "name"=>"Lung Diseases", "relevance"=>"LOW"}, {"id"=>"M11170", "name"=>"Lung Diseases, Obstructive", "relevance"=>"LOW"}, {"id"=>"M10018", "name"=>"Hypersensitivity", "relevance"=>"LOW"}, {"id"=>"M14967", "name"=>"Respiratory Hypersensitivity", "relevance"=>"LOW"}, {"id"=>"M10020", "name"=>"Hypersensitivity, Immediate", "relevance"=>"LOW"}, {"id"=>"M10200", "name"=>"Immune System Diseases", "relevance"=>"LOW"}, {"id"=>"M14957", "name"=>"Respiration Disorders", "relevance"=>"LOW"}, {"id"=>"M15623", "name"=>"Signs and Symptoms, Respiratory", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Behaviors and Mental Disorders", "abbrev"=>"BXM"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Respiratory Tract (Lung and Bronchial) Diseases", "abbrev"=>"BC08"}, {"name"=>"Immune System Diseases", "abbrev"=>"BC20"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"NON_RANDOMIZED", "maskingInfo"=>{"masking"=>"SINGLE", "whoMasked"=>["OUTCOMES_ASSESSOR"], "maskingDescription"=>"Participants and researchers could not be blinded due to the natural course of the study and only the statistician was blinded."}, "primaryPurpose"=>"OTHER", "interventionModel"=>"PARALLEL", "interventionModelDescription"=>"pre-test post-test quasi-experimental design"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>48}}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-10-01", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2025-02-15", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-09-25", "studyFirstSubmitDate"=>"2024-09-25", "studyFirstSubmitQcDate"=>"2024-09-25", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-27", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-27", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-12-31", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Anxiety", "timeFrame"=>"Average of 1 week after completion of the intervention", "description"=>"It will be evaluated with the Hospital Anxiety and Depression Scale."}, {"measure"=>"Depression", "timeFrame"=>"Average of 1 week after completion of the intervention", "description"=>"It will be evaluated with the Hospital Anxiety and Depression Scale."}, {"measure"=>"Dyspnea", "timeFrame"=>"Average of 1 week after completion of the intervention", "description"=>"It will be assessed with the Modified Medical Research Council (mMRC) Dyspnoea Questionnaire."}]}, "oversightModule"=>{"oversightHasDmc"=>true, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["asthma", "mindfulness-based cognitive therapy", "anxiety", "depression", "dyspnea"], "conditions"=>["Asthma", "Mindfulness"]}, "referencesModule"=>{"references"=>[{"pmid"=>"13003946", "type"=>"BACKGROUND", "citation"=>"FLETCHER CM. The clinical diagnosis of pulmonary emphysema; an experimental study. Proc R Soc Med. 1952 Sep;45(9):577-84. No abstract available."}, {"pmid"=>"6723384", "type"=>"BACKGROUND", "citation"=>"Mahler DA, Weinberg DH, Wells CK, Feinstein AR. The measurement of dyspnea. Contents, interobserver agreement, and physiologic correlates of two new clinical indexes. Chest. 1984 Jun;85(6):751-8. doi: 10.1378/chest.85.6.751."}, {"pmid"=>"6880820", "type"=>"BACKGROUND", "citation"=>"Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x."}]}, "descriptionModule"=>{"briefSummary"=>"In this study, short-term MBCT will be applied to asthmatic patients receiving hospital treatment and its effects on anxiety, depression and dyspnea will be determined. A quasi-experimental study was planned for this purpose.", "detailedDescription"=>"In the study, cognitive behavioral therapy will be applied to the intervention group, which is determined as the experimental group, and a group of asthma patients who did not receive any application during the same periods will be included and the dyspnea, anxiety and depression levels of the patients in these two groups will be compared."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria:\n\nOver 18 years old, Inpatient treatment in the chest ward volunteer participants with no communication problems\n\nExclusion Criteria:\n\nUnder 18 years old, with communication problems, not willing to participate hospitalized with diseases other than asthma"}, "identificationModule"=>{"nctId"=>"NCT06617143", "acronym"=>"MBCT", "briefTitle"=>"Effect of MBCT Applied to Asthma Patients on Anxiety, Depressıon and Dyspnea", "organization"=>{"class"=>"OTHER", "fullName"=>"Ardahan University"}, "officialTitle"=>"Effects of Short-Term Conscious Awareness-Based Cognitıve Therapy Applied to Asthma Patients on Anxiety, Depression and Dyspnea", "orgStudyIdInfo"=>{"id"=>"ArdahanU-Şimsekli-DS-03"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Experimental group", "description"=>"In this study, it is planned to apply MBCT to asthmatic inpatients in the patient room in groups of 2 or 3. This application is planned to continue for one hour.", "interventionNames"=>["Other: mindfulness-based cognitive therapy"]}, {"type"=>"ACTIVE_COMPARATOR", "label"=>"Control group", "description"=>"No application will be made to the patients in the control group.", "interventionNames"=>["Other: routine treatment and care"]}], "interventions"=>[{"name"=>"mindfulness-based cognitive therapy", "type"=>"OTHER", "description"=>"In this study, it is planned to apply MBCT to asthmatic inpatients in the patient room in groups of 2 or 3. This application is planned to continue for one hour.", "armGroupLabels"=>["Experimental group"]}, {"name"=>"routine treatment and care", "type"=>"OTHER", "description"=>"routine treatment and care", "armGroupLabels"=>["Control group"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"75100", "city"=>"Ardahan", "country"=>"Turkey", "facility"=>"Ardahan University", "geoPoint"=>{"lat"=>41.10871, "lon"=>42.70222}}], "centralContacts"=>[{"name"=>"Derya Ş ŞİMŞEKLİ, PhD", "role"=>"CONTACT", "email"=>"deryasimsekli95@gmail.com", "phone"=>"05545965789", "phoneExt"=>"+90"}, {"name"=>"Birsen Güngör Kaya, Msc", "role"=>"CONTACT", "email"=>"birsenkaya@ardahan.edu.tr"}], "overallOfficials"=>[{"name"=>"Derya ŞİMŞEKLİ, PhD", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Ardahan University"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Ardahan University", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
