[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100562675":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":40,"responsibleParty":92,"collaborators":95,"id":99,"slug":100,"hasResults":101,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":105,"eligibilityCriteria":106,"healthyVolunteers":107,"sex":108,"minAge":109,"maxAge":30,"enrollmentInfo":110,"targetDuration":30,"studyType":113,"phases":114,"briefSummary":116,"conditions":117,"keywords":122,"overallStatus":63,"whyStopped":30,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":136},{"fullName":5,"class":6},"University of Padova","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Self-Help Plus (SH+)","EXPERIMENTAL","The intervention is available in its individual online self-help version called \"Doing What Matters in Time of Stress\". It composed of an illustrate guide, divided into sessions, and pre-recorded audio.\n\nParticipants will be required to access an online platform for attending the sessions. A total of 5 sessions of approximately an hour each are planned. Participants will be guided by facilitators with minimal qualifications and skills in providing psychosocial support. They will receive regular reminders and instructions from helpers at the beginning of the program and before any sessions via phone call, teleconferencing meeting, or message. Facilitators will receive brief training from specialized mental health professionals trained by WHO.",[13],"Behavioral: Self-Help Plus (SH+)",{"label":15,"type":16,"description":17,"interventionNames":18},"Psychological First Aid (PFA)","ACTIVE_COMPARATOR","Psychological First Aid will also be delivered by facilitators through a phone call or teleconferencing meeting, for an approximate ranging from 20 to 45 minutes. Participants will also receive an information sheet with details about mental health services available for students experiencing distress at each of the centers.",[19],"Behavioral: Psychological First Aid (PFA)",[21,27],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"BEHAVIORAL","Self-Help Plus is a novel, brief, low-intensity intervention, recently developed by the World Health Organization (WHO) and intended to help people with and without mental disorders cope with distress stemming from diverse types of adversity.The key components of the program are based on acceptance and commitment therapy (ACT), a distinct form of cognitive-behavioural therapy. SH+ draws on ACT techniques of coping with stress, compassion and acceptance toward oneself and others, and living following one's values.\n\nAn online version called \"Doing what matters in times of stress\" is available as an illustrated guide and pre-recorded audio.",[9],[26],"Doing what matters in times of stress",{"type":22,"name":15,"description":28,"armGroupLabels":29,"otherNames":30},"Psychological First Aid (PFA) is also developed by the WHO and is a general supportive intervention, aimed at listening and understanding the needs and concerns of people, providing support without pressuring them to talk.",[15],null,[32],{"name":33,"affiliation":5,"role":34},"Ioana Cristea, PhD","PRINCIPAL_INVESTIGATOR",[36],{"name":33,"role":37,"phone":38,"phoneExt":30,"email":39},"CONTACT","390498276595","ioanaalina.cristea@unipd.it",[41,62,77],{"facility":42,"status":43,"city":44,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"University of Bari \"Aldo Moro\"","NOT_YET_RECRUITING","Bari","70121","Italy","IT",{"type":49,"coordinates":50},"Point",[51,52],16.86982,41.12066,{"lat":52,"lon":51},[55,59],{"name":56,"role":37,"phone":57,"phoneExt":30,"email":58},"Emilia Matera, Ph.D.","0805595258","emilia.matera@uniba.it",{"name":60,"role":61,"phone":30,"phoneExt":30,"email":30},"Lucia Margari, MD","SUB_INVESTIGATOR",{"facility":5,"status":63,"city":64,"state":30,"zip":65,"country":46,"countryCode":47,"cosmosGeoPoint":66,"geoPoint":70,"contacts":71},"RECRUITING","Padova","35131",{"type":49,"coordinates":67},[68,69],11.14261,44.38225,{"lat":69,"lon":68},[72,76],{"name":73,"role":37,"phone":74,"phoneExt":30,"email":75},"Marcella Lucente, PhD","+390498276595","marcella.lucente@unipd.it",{"name":33,"role":34,"phone":30,"phoneExt":30,"email":30},{"facility":78,"status":63,"city":79,"state":30,"zip":30,"country":46,"countryCode":47,"cosmosGeoPoint":80,"geoPoint":84,"contacts":85},"Universita di Verona","Verona",{"type":49,"coordinates":81},[82,83],10.9938,45.43854,{"lat":83,"lon":82},[86,90],{"name":87,"role":37,"phone":88,"phoneExt":30,"email":89},"Federica Patania, MSc","+039045 8124884","federica.patania@univr.it",{"name":91,"role":34,"phone":30,"phoneExt":30,"email":30},"Marianna Purgato, PhD",{"type":34,"investigatorFullName":93,"investigatorTitle":94,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"CRISTEA IOANA ALINA","Associate Professor",[96,97],{"name":78,"class":6},{"name":98,"class":6},"University of Bari Aldo Moro","100562675","self-help-plus-for-distress-in-university-students-100562675",false,"NCT06606249","Self-Help Plus for Distress in University Students","Randomized Trial of a Brief, Transdiagnostic, Guided Self-help Intervention for University Students Who Are Behind on Their Coursework and Experience Distress","SSH+","Inclusion Criteria:\n\n* University students across all years of higher education (i.e., bachelor and masters), enrolled in any degree course, starting from the second semester of the 1st year\n* Currently behind coursework by at least 3 exams, including: exams failed, for which the obtained grade was not confirmed by the student (i.e., confirming the grade is mandatory in the Italian academic system), or postponed (i.e., not taken in the regularly scheduled period).\n* Experience significant distress as assessed by the Kessler psychological distress scale (K-10) ≥ 16.\n\nExclusion Criteria:\n\n• None",true,"ALL","18 Years",{"count":111,"type":112},210,"ESTIMATED","INTERVENTIONAL",[115],"NA","Prrospective, multi-center, randomized controlled trial of a brief, transdiagnostic, guided self-help intervention (Self-Help Plus) for university students who experience significant distress and are behind on their coursework. The intervention will be tested in terms of efficacy and feasibility for outcomes related to distress, anxiety, depression and well-being, assessed immediately after the intervention and at 3-months follow-up.",[118,119,120,121],"Psychological Distress","Psychological Well-Being","Depression","Anxiety",[123,124,125,126],"prevention","university students","academic deceit","emotion regulation","2026-03-11",{"date":129,"type":130},"2026-03-13","ACTUAL",{"date":132,"type":130},"2025-03-10",{"date":134,"type":112},"2027-01",{"name":5,"class":6},3]