[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100577950":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":34,"locations":40,"responsibleParty":59,"collaborators":62,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":68,"sex":74,"minAge":75,"maxAge":25,"enrollmentInfo":76,"targetDuration":25,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":85,"overallStatus":43,"whyStopped":25,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Karolinska Institutet","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Online transdiagnostic CBT","EXPERIMENTAL","Participants randomized to this arm will receive the intervention online transdiagnostic CBT (see Interventions).",[13],"Behavioral: Online transdiagnostic CBT",{"label":15,"type":16,"description":17,"interventionNames":18},"Primary care as usual","ACTIVE_COMPARATOR","Patients randomized to this study condition will receive health care services as usual in primary care.",[19],"Other: Primary care as usual",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"BEHAVIORAL","This treatment is provided through a secure web platform in which psychoeducation, worksheets, and exercises are presented in online modules similar to chapters in a book. Participants will receive weekly written feedback on their work and progress by a therapist who gives gradual access to the treatment modules. The lion's share of the contact between the therapist and the patient thus takes place through messages (similar to email) in the online treatment platform. It is however allowed to also have one to three face-to-face sessions on-site or through video calls to provide technical assistance and therapeutic support in accordance with the treatment model. Core components are: (a) psychoeducation about emotions and CBT, (b) functional analysis, (c) mindfulness practice, (d) breaking dysfunctional emotion-driven behaviors, and (e) exposure exercises.",[9],null,{"type":6,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"It is mandatory for primary care services in Stockholm, Sweden, to have staff with adequate competence in the assessment and treatment of common mental disorders. Typically, these patients are handled by general practitioners, psychologists, nurses, or social workers. As this comparator is intended to reflect real routine primary care, the interventions will not be controlled by the research project. We expect that participants allocated to this condition will receive an active treatment.",[15],[30],{"name":31,"affiliation":32,"role":33},"Erik Hedman-Lagerlöf, PhD, professor","Region Stockholm and Karolinska Institutet","PRINCIPAL_INVESTIGATOR",[35],{"name":36,"role":37,"phone":38,"phoneExt":25,"email":39},"Mari von Bahr Bentzer, MSc.","CONTACT","+46 8 123 395 50","mari.vonbahr-bentzer@regionstockholm.se",[41],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Region Stockholm, Gustavsberg Primary Care Center","RECRUITING","Gustavsberg","Stockholm County","134 40","Sweden","SE",{"type":50,"coordinates":51},"Point",[52,53],18.38975,59.32684,{"lat":53,"lon":52},[56],{"name":57,"role":37,"phone":38,"phoneExt":25,"email":58},"Erik Hedman-Lagerlöf, Phd, Professor","erik.hedman-lagerlof@ki.se",{"type":33,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Erik Hedman","Professor, PhD",[63],{"name":64,"class":65},"Region Stockholm","OTHER_GOV","100577950","transdiagnostic-online-cbt-vs-care-as-usual-for-primary-care-patients-with-subsyndromal-mental-ill-health--primarita-2--100577950",false,"NCT06804954","Transdiagnostic Online CBT Vs. Care As Usual for Primary Care Patients with Subsyndromal Mental Ill-health ( PRIMARITA-2 )","Internet-based Transdiagnostic Cognitive Behavior Therapy and Care As Usual for Primary Care Patients with Mental Ill-health (RCT-2: Subsyndromal Mental Ill-health)","PRIMARITA-2","Inclusion Criteria:\n\nTo be included patients have to:\n\n1. To be included patients have to: (a) have a subsyndromal mental health problem concerning anxiety, depressive symptoms, or stress-related ill-health that warrants treatment,\n2. be at least 18 years old,\n3. have regular access to a device with an Internet connection,\n4. be able to read and write in Swedish,\n5. have no severe psychiatric disorder that requires specialized psychiatric care, such as psychosis, bipolar disorder, or anorexia nervosa,\n6. if on medication with monoamine agonist, have stable dosage in the past month,\n7. have no on-going psychological treatment, and\n8. provide written informed consent for participation and complete baseline assessment\n\nExclusion criteria:\n\nAs the targeted population in this trial is primary care patients with subsyndromal mental ill-health that do not have a manifest specific common mental disorder, patients will be excluded if they meet diagnostic criteria for an anxiety disorder (social phobia, panic disorder, agoraphobia, general anxiety disorder, or specific phobia), a health anxiety disorder (hypochondriasis or illness anxiety disorder), obsessive-compulsive disorder, depression (depression or dysthymia), or a stress-related disorder (exhaustion disorder, adjustment disorder, or post-traumatic stress disorder). Note that meeting diagnostic criteria for not otherwise specified disorders (e.g., anxiety not otherwise specified), mixed anxiety and depressive disorder, or disorders subsumed under \"other\" categories is not a reason for exclusion.","ALL","18 Years",{"count":77,"type":78},500,"ESTIMATED","INTERVENTIONAL",[81],"NA","The goal of this randomized controlled trial is to investigate if online transdiagnostic cognitive behavior therapy (CBT) can be effective in the treatment of subsyndromal mental ill-health in adult primary care patients. The main aim is to investigate:\n\nif online transdiagnostic CBT yields superior symptomatic improvement compared to care-as-usual when given in a primary care context to patients with mental ill-health.\n\nResearchers will compare online transdiagnostic CBT to primary care as usual to see if psychiatric symptoms can be reduced.\n\nParticipants will be randomized to online transdiagnostic CBT or primary care as usual. Participants in online transdiagnostic CBT will receive a cognitive behavioral treatment provided through a secure web platform in which psychoeducation, worksheets, and exercises are presented in online modules similar to chapters in a book. Participants will receive weekly written feedback on their work and progress by a therapist who gives gradual access to the treatment modules. The lion's share of the contact between the therapist and the patient thus takes place through messages (similar to email) in the online treatment platform.\n\nParticipants randomized to care as usual will receive health care services as usual in primary care. As this comparator is intended to reflect real routine primary care, the interventions will not be controlled by the research project, but the investigators expect that participants will receive an active treatment.",[84],"Mental Ill-health",[86,87,88,89],"Primary Care","Transdiagnostic CBT","Online treatment","Subsyndromal mental ill-health","2025-03-05",{"date":92,"type":93},"2025-03-07","ACTUAL",{"date":95,"type":93},"2025-02-25",{"date":97,"type":78},"2029-02-06",{"name":5,"class":6},1]