[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100543522":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":35,"centralContacts":72,"locations":78,"responsibleParty":106,"collaborators":109,"id":120,"slug":121,"hasResults":122,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":126,"eligibilityCriteria":127,"healthyVolunteers":128,"sex":129,"minAge":130,"maxAge":12,"enrollmentInfo":131,"targetDuration":12,"studyType":134,"phases":135,"briefSummary":137,"conditions":138,"keywords":140,"overallStatus":81,"whyStopped":12,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":148,"completionDateStruct":149,"leadSponsor":151,"locationsCount":152},{"fullName":5,"class":6},"University of Bergamo","OTHER",[8,13,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment as usual (TAU)","NO_INTERVENTION","TAU: therapists and patients proceed with psychotherapy as they normally would without receiving any initial training and using only Mindy as a simplified digital folder.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"OPM","ACTIVE_COMPARATOR","Process and outcome monitoring (OPM) in which patients will complete process and outcome measures with \"baseline\" feedback related to each psychotherapy session, but therapists will not receive support with clinical support tools on these measures, will not have specific training on Feedback Informed Therapy (FIT), and will not receive monthly supervision, but rather will use the Mindy platform as a medical record",[18],"Behavioral: Feedback and ROM (basic)",{"label":20,"type":21,"description":22,"interventionNames":23},"OPM-F","EXPERIMENTAL","Process and outcome monitoring with feedback (OPM-F) in which patients will complete process and outcome measures related to each session, and therapists will receive feedback on patient progress and patient experiences of the therapeutic alliance with specific training on feedback informed therapy (FIT) and use the Mindy platform with all information inherent to feedback and Clinical Support Tools, they will also receive monthly supervision\u002Fcoaching (for three months) designed to complete on-going training on FIT and ROM, with practical discussion of the most difficult clinical cases and possible solutions to be implemented in therapy.",[24,18],"Behavioral: (Feedback Informed Therapy) with Clinical Support Tools and ah hoc training",[26,31],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":12},"BEHAVIORAL","(Feedback Informed Therapy) with Clinical Support Tools and ah hoc training","Therapists in the condition (OPM-F) will receive specific training on the procedures and techniques inherent in feedback informed therapy (FIT); during the intervention phase (lasting 15 sessions) the Clinical Support System in FIT will guide them in the clinical application of the procedures. In addition, they will receive monthly supervision (for three months) apt to provide on-going clinical support on FIT and ROM, with practical discussion of the most difficult clinical cases and possible solutions to be implemented in therapy.",[20],{"type":27,"name":32,"description":33,"armGroupLabels":34,"otherNames":12},"Feedback and ROM (basic)","Process and outcome monitoring (OPM) in which patients will complete process and outcome measures related to each psychotherapy session but therapists will receive basic feedback on these measures",[14,20],[36,40,43,46,49,51,54,57,59,61,64,67,70],{"name":37,"affiliation":38,"role":39},"Gianluca Lo Coco, Full Professor","University of Palermo (Italy)","PRINCIPAL_INVESTIGATOR",{"name":41,"affiliation":42,"role":39},"Masella Cristina, Full Professor","\"Politecnico\" Milan (Italy)",{"name":44,"affiliation":45,"role":39},"Giorgio A. Tasca, Full Professor","School of Psychology, University of Ottawa (Canada)",{"name":47,"affiliation":48,"role":39},"Barbara Poletti, Professor","Scuola di Psicoterapia Integrata (Bergamo) Italy",{"name":50,"affiliation":48,"role":39},"Luca Pievani, Dr.",{"name":52,"affiliation":53,"role":39},"Antonino Carcione, Professor","Terzocentro di Psicoterapia Cognitiva (Roma) Italy",{"name":55,"affiliation":56,"role":39},"Antonino La Tona, Dr.","University of Bergamo (Italy)",{"name":58,"affiliation":42,"role":39},"Mattia V. Olive, Dr.",{"name":60,"affiliation":5,"role":39},"Agostino Brugnera, Assistant Professor",{"name":62,"affiliation":63,"role":39},"Gary M. Burlingame, Full Professor","Brigham Young University (Utah)",{"name":65,"affiliation":66,"role":39},"Kim De Jong, Full Professor","Leiden University",{"name":68,"affiliation":69,"role":39},"Michael Barkham, Full Professor","University of Sheffield",{"name":71,"affiliation":69,"role":39},"Jaime Delgadillo, Full Professor",[73],{"name":74,"role":75,"phone":76,"phoneExt":12,"email":77},"Angelo Compare, Full Professor","CONTACT","+39 0352052989","angelo.compare@unibg.it",[79,98],{"facility":80,"status":81,"city":82,"state":83,"zip":84,"country":85,"countryCode":86,"cosmosGeoPoint":87,"geoPoint":92,"contacts":93},"University of Bergamo (DSUS)","RECRUITING","Bergamo","Italia","24125","Italy","IT",{"type":88,"coordinates":89},"Point",[90,91],9.66721,45.69601,{"lat":91,"lon":90},[94,97],{"name":55,"role":75,"phone":95,"phoneExt":12,"email":96},"+39 3884445674","antonino.latona@unibg.it",{"name":55,"role":39,"phone":12,"phoneExt":12,"email":12},{"facility":5,"status":81,"city":82,"state":83,"zip":84,"country":85,"countryCode":86,"cosmosGeoPoint":99,"geoPoint":101,"contacts":102},{"type":88,"coordinates":100},[90,91],{"lat":91,"lon":90},[103],{"name":104,"role":75,"phone":105,"phoneExt":12,"email":96},"Antonino La Tona","3884445674",{"type":39,"investigatorFullName":107,"investigatorTitle":108,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"Angelo Compare","Prof. Angelo Compare",[110,112,113,115,116,118],{"name":111,"class":6},"Politecnico di Milano",{"name":66,"class":6},{"name":114,"class":6},"University of Ottawa",{"name":69,"class":6},{"name":117,"class":6},"Brigham Young University",{"name":119,"class":6},"University of Palermo","100543522","routine-outcome-monitoring-and-feedback-informed-therapy-in-italy-100543522",false,"NCT06356961","Routine Outcome Monitoring and Feedback Informed Therapy in Italy","Routine Outcome Monitoring and Feedback Informed Therapy in Italy: 1st Italian RCT Large Population Study (PRIN - Italian Minister of Universities and Research Project)","FIT-ITALY","Inclusion Criteria:\n\n* Terapists with a regular specialisation diploma in psychotherapy recognised by the MIUR (https:\u002F\u002Fwww.miur.it\u002FElencoSSPWeb\u002F), in activity; and\u002For specialising in psychotherapy at least in their third year will be selected.\n\nThere will be no restrictions on the type of psychotherapy used by the professionals who will be recruited (the only criterion for inclusion is that it must be psychotherapy for a mental health issue).\n\n* Patients: Approximately 1500 to 2000 patients will be recruited, 5 new patients per therapist.\n* New patients seen for less than 3 sessions.\n* Adult patients, 18 years of age or older.\n\nExclusion Criteria:\n\n* Patients: - No restrictions on diagnoses except for the following: Psychosis and neurocognitive disorders, because as pointed out by Barkham and colleagues when using ROM and FIT the clinical population and context must be considered.",true,"ALL","18 Years",{"count":132,"type":133},180,"ESTIMATED","INTERVENTIONAL",[136],"NA","The research project OutProFeed - Italy: Routine outcome monitoring and feedback informed therapy in Italy: 1st Italian RCT large population study, represents the first Italian randomised controlled trial (RCT) to evaluate the effectiveness of feedback-informed psychotherapy (FIT) to improve patients mental health outcomes and psychotherapy processes through the use of the digital platform Mindy.\n\nThe following project was awarded PRIN 2022 funding by the Ministry of University and Research (MUR). This project has the University of Bergamo as lead partner, with the auxiliary participation of the University of Palermo and the Polytechnic University of Milan.\n\nGiven the innovative-experimental nature of the following research project, a digital platform -Mindy- will be used, which allows the recruited professionals (once registered) an all-round management of all the professional activities inherent to the psychologist\u002Fpsychotherapist profession (informed consent, online therapy, administration of psychometric instruments, etc.) and which also facilitates the administration of psychometric instruments. ) and which also facilitates data collection, subsequent analysis and Routine Outcome Monitoring (ROM) and Feedback Informed Therapy (FIT) procedures with ad hoc charts and digital tools, in accordance with the guidelines dictated by the GDPR regulations on health and clinical data. Each therapist involved in the project, after having received guidance on the procedures and after having been instructed to use the platform will involve 5 new patients in the following project. The only inclusion criteria for patients are the following:\n\nI) Being of legal age II) Not having a diagnosis of psychosis and\u002For neurocognitive disorders III) Consent to participate in the following research project IV) Being a new patient (new or less than three sessions carried out) We will randomly assign the previously recruited psychotherapists and their patients to one of three conditions: (1) treatment as usual (TAU) in which therapists and patients proceed with psychotherapy as they normally would without receiving any initial training and using only Mindy as a simplified digital folder (2) process and outcome monitoring (OPM) in which patients will complete process and outcome measures related to each psychotherapy session therapists will receive basic feedback without Clinical Support Tools on these measures, they will use the Mindy platform as a medical record and will not receive specific training on FIT (3) process and outcome monitoring with feedback (OPM-F) where patients will complete process and outcome measures related to each session and therapists will receive feedback on the patient progress and experiences of the therapeutic alliance with specific training on feedback informed therapy (FIT) and will use the Mindy platform with all feedback and Clinical Support Tools information, They will also receive monthly supervision\u002Fcoaching (for three months) to complete the FIT and ROM training on-going, with practical discussion of the most difficult clinical cases and possible solutions to be implemented in therapy.\n\nRecruitment of therapists will take place with the strategic participation of a pool of MIUR-recognised Schools of Specialisation in Psychotherapy (https:\u002F\u002Fwww.miur.it\u002FElencoSSPWeb\u002F).\n\nProfessionals qualified to practise as psychologists who are in their third year of the Schools of Psychotherapy will be selected, as well as therapists who already have a regular diploma of specialisation in psychotherapy recognised by the MIUR (https:\u002F\u002Fwww.miur.it\u002FElencoSSPWeb\u002F), and who are in active practice. There will be no restrictions on the type of psychotherapy used by the professionals who will be recruited (the only criterion for inclusion is that it must be psychotherapy for a mental health issue). Therapists will not be aware of the randomisation procedure to reduce bias (Zelen design). Specifically, for the following research project we will use data from a maximum of 15 sessions (endpoints) carried out by all therapists of the 3 groups with the Clinical Support System only for the therapists of the group (OPM-F) who, as previously mentioned, will receive ad hoc training; furthermore, various instruments (described in the special section Instruments) will be compiled through the functional use of Mindy and in detail (cadence, purpose and research hypotheses) in the complete protocol in the next section. Finally, through the administration of special questionnaires, factors indicative of therapists aptitude and competences for the use of digital tools in professional practice will be collected in order to obtain statistical clusters that can be used as independent or control variables.",[139],"Feedback, Psychological",[141,142,143],"Routine outcome monitoring (ROM)","PRIN-Italy-OutProFeed.","Feedback informed therapy (FIT)","2025-03-25",{"date":146,"type":147},"2025-03-30","ACTUAL",{"date":144,"type":133},{"date":150,"type":133},"2025-10-05",{"name":5,"class":6},2]