[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100431588":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":42,"centralContacts":47,"locations":54,"responsibleParty":112,"collaborators":115,"id":122,"slug":123,"hasResults":124,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":128,"eligibilityCriteria":129,"healthyVolunteers":124,"sex":130,"minAge":131,"maxAge":52,"enrollmentInfo":132,"targetDuration":52,"studyType":135,"phases":136,"briefSummary":138,"conditions":139,"keywords":52,"overallStatus":74,"whyStopped":52,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":162},{"fullName":5,"class":6},"Linnaeus University","OTHER",[8,14,20,24],{"label":9,"type":10,"description":11,"interventionNames":12},"Diagnostic Assessment - Given self-help CBT","EXPERIMENTAL","The diagnostic assessment includes screening instruments, a structured interpretation of the screening instruments, a structured interview (MINI - International Neuropsychiatric Interview) and a medical anamnesis. If deemed appropriate, the patient can be offered treatment with guided self help. If the patient's problem is not deemed appropriate for this type of care or if the patient is not interested in guided self-help, they are offered brief interventions (BI).\n\nIn the primary analysis, only patients receiving treatment with self-help CBT are included.",[13],"Behavioral: Self-help CBT",{"label":15,"type":16,"description":17,"interventionNames":18},"Contextual Assessment - Suitable for self-help CBT but given brief interventions","ACTIVE_COMPARATOR","The contextual assessment includes screening instruments and a contextual interview. Patients in this arm will always be treated with brief interventions.\n\nIn the primary analysis, only patients suitable for self-help CBT are included. This is decided by an algorithm based on data from their screening, which takes into account symptom severity and type, patient preference and known variables that make self-help CBT a worse fit.",[19],"Behavioral: Brief interventions",{"label":21,"type":10,"description":22,"interventionNames":23},"Diagnostic Assessment - All patients","Same as the other arm marked as \"Experimental\", but for the purpose of a secondary analysis all patients randomised to Diagnostic Assessment are included, regardless if they receive treatment with self-help CBT or brief interventions.",[19,13],{"label":25,"type":16,"description":26,"interventionNames":27},"Contextual Assessment - All patients","Same as the other arm marked as \"Experimental\", but for the purpose of a secondary analysis all patients randomised to Diagnostic Assessment are included, regardless if they are deemed suitable for self-help CBT or not.",[19],[29,36],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"BEHAVIORAL","Brief interventions","'Brief Interventions' (BI) is a generic term for a multitude of tools and interventions used in patient visits within PCBH. BI start immediately at the initial consultation, which ends with a personally tailored and evidence-informed plan adjusted to the patient's context. As such, there is no separation between assessment and intervention. The interventions within BI often have their foundation in CBT, ACT or Motivational Interviewing (MI). The common theme is that they are principle-based rather than manual-based and focus on behavioural change in relation to a problem, rather than focusing on a specific diagnosis. Follow-up appointments are scheduled flexibly depending on the patient's perceived need. A BI treatment usually consists of 1-4 appointments with several weeks apart and has an open ending, where the patient easily can schedule a new appointment. Clinicians delivering brief interventions will have had 3 days of training as well as regular supervision.",[25,15,21],[35],"Focused CBT, focused ACT, Focused Cognitive Behavioural Therapy, Focused Acceptance and Commitment Therapy",{"type":30,"name":37,"description":38,"armGroupLabels":39,"otherNames":40},"Self-help CBT","The patient receives a previously scientifically evaluated CBT-based self-help book for one of the following conditions: depression, generalized anxiety disorder, panic disorder, social anxiety, health anxiety, insomnia, or stress\u002Fburnout. The therapist support consists of 3-6 contacts throughout the 6-12 weeks long intervention period as decided by the clinician and patient together, as long as at least one and not more than three are physical visits at the center and the rest via phone, video conferencing, or secure internet messages. Clinicians delivering self-help CBT will need four days of reading and two days of training as well as regular supervision to be able to make initial assessments and problem profiling and use the self-help books.",[21,9],[41],"Bibliotherapy, iCBT, Internet-Based Cognitive Behavioural Therapy, Blended Treatment, Self-help books",[43],{"name":44,"affiliation":45,"role":46},"Viktor Kaldo, Professor","Linnaeus University, Karolinska Institutet","PRINCIPAL_INVESTIGATOR",[48],{"name":49,"role":50,"phone":51,"phoneExt":52,"email":53},"Anneli Farnsworth von Cederwald","CONTACT","+46722372300",null,"anneli.farnsworthvoncederwald@lnu.se",[55,72,86,99],{"facility":56,"status":57,"city":58,"state":59,"zip":52,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":68},"Vårdcentralen Västra Vall","NOT_YET_RECRUITING","Varberg","Halland County","Sweden","SE",{"type":63,"coordinates":64},"Point",[65,66],12.25078,57.10557,{"lat":66,"lon":65},[69],{"name":70,"role":50,"phone":52,"phoneExt":52,"email":71},"Filip Axell","filip.axell@regionhalland.se",{"facility":73,"status":74,"city":75,"state":76,"zip":52,"country":60,"countryCode":61,"cosmosGeoPoint":77,"geoPoint":81,"contacts":82},"Capio Citykliniken Västra Hamnen","RECRUITING","Malmö","Skåne County",{"type":63,"coordinates":78},[79,80],13.00073,55.60587,{"lat":80,"lon":79},[83],{"name":84,"role":50,"phone":52,"phoneExt":52,"email":85},"Marit Bengtson","marit.bengtson@capio.se",{"facility":87,"status":57,"city":88,"state":89,"zip":52,"country":60,"countryCode":61,"cosmosGeoPoint":90,"geoPoint":94,"contacts":95},"Boo vårdcentral","Stockholm","Stockholm County",{"type":63,"coordinates":91},[92,93],18.06871,59.32938,{"lat":93,"lon":92},[96],{"name":97,"role":50,"phone":52,"phoneExt":52,"email":98},"Katrin Hagskog Engel","katrin.hagskog-engel@sll.se",{"facility":100,"status":74,"city":101,"state":102,"zip":52,"country":60,"countryCode":61,"cosmosGeoPoint":103,"geoPoint":107,"contacts":108},"Capio Vårdcentral Sävja","Uppsala","Uppsala County",{"type":63,"coordinates":104},[105,106],17.63889,59.85882,{"lat":106,"lon":105},[109],{"name":110,"role":50,"phone":52,"phoneExt":52,"email":111},"Linnea Fällström","linnea.fallstrom@capio.se",{"type":46,"investigatorFullName":113,"investigatorTitle":114,"investigatorAffiliation":5,"oldNameTitle":52,"oldOrganization":52},"Viktor Kaldo","Professor",[116,118,120],{"name":117,"class":6},"The Kamprad Family Foundation for Entrepreneurship, Research & Charity",{"name":119,"class":6},"Capio Group",{"name":121,"class":6},"Karolinska Institutet","100431588","evaluation-of-primary-care-behavioral-health-pcbh-with-the-addition-of-self-help-cbt---a-randomized-multicenter-trial-100431588",false,"NCT04900064","Evaluation of Primary Care Behavioral Health (PCBH) With the Addition of Self-help CBT - A Randomized Multicenter Trial","Evaluation of Primary Care Behavioral Health (PCBH) With the Addition of Self-help CBT - A Randomized Multicenter Trial for Superiority and Non-superiority Comparisons of Effects on Patients' Everyday Function, Symptoms, and Experiences","KAIROS","Inclusion Criteria:\n\n* All patients from age 18 who seek care at the PCC, who are deemed to be suitable for Behavioural Health interventions and booked to the mental health professionals at the PCC, according to screening methods and\u002For clinical assessments made by health care personnel at the PCC, will be included. This broad criteria reflects the naturalistic setting where decisions of clinicians, rather than highly standardized criteria, are the basis for inclusion.\n\nExclusion Criteria:\n\n* Does not speak Swedish well enough to fill out questionnaires or to receive self-help CBT in Swedish.\n* Is in need of emergency type care, like with suicidal ideation or behaviours, ongoing psychosis or mania.","ALL","18 Years",{"count":133,"type":134},1242,"ESTIMATED","INTERVENTIONAL",[137],"NA","In this multicenter study, the investigators want to find out if an addition of an diagnostic assessment and possibility of treatment with guided self-help CBT can increase the treatment effects of PCBH on patient functioning and symptoms, compared to standard PCBH which uses contextual assessment and brief interventions. In addition to this, the study will investigate the overall effect of PCBH on both patient and organisation level outcomes.",[140,141,142,143,144,145,146,147,148,149,150,151,152],"Panic Disorder","Social Anxiety Disorder","Depression","Hypochondriasis","Insomnia","Generalized Anxiety Disorder","Burnout","Adjustment Disorders","Stress, Psychological","Obsessive-Compulsive Disorder","Life Stress","Life Style Induced Illness","Psychological Distress","2025-04-08",{"date":155,"type":156},"2025-04-11","ACTUAL",{"date":158,"type":156},"2021-06-14",{"date":160,"type":134},"2026-12-31",{"name":5,"class":6},4]