[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100510557":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":39,"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":18,"enrollmentInfo":76,"targetDuration":18,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":87,"overallStatus":42,"whyStopped":18,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"VU University of Amsterdam","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Problem Management Plus and care-as-usual","EXPERIMENTAL","The five sessions of PM+ will be delivered by trained master students in clinical psychology on an individual basis. Care-as-usual will not be withheld.",[13],"Behavioral: Problem Management Plus (PM+)",{"label":15,"type":16,"description":17,"interventionNames":18},"Care-as-usual","NO_INTERVENTION","Care-as-usual includes all social, health, and mental health services already available for individuals detained in Dutch prisons.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"BEHAVIORAL","Problem Management Plus (PM+)","Problem Management Plus (PM+) is a brief, psychological intervention program based on cognitive behavioural therapy (CBT) techniques that are empirically supported and formally recommended by the WHO (Dua et al., 2011; Tol et al., 2013). The full protocol was developed by the WHO and the University of New South Wales, Australia. The manual involves the following empirically supported elements: problem-solving, stress management, behavioural activation, and accessing social support. PM+ has three core features. It is brief (five sessions given in five weeks), delivered by paraprofessionals (PM+ helpers) and transdiagnostic. The PM+ helpers will be supervised by mental health care specialists.",[9],[26],{"name":27,"affiliation":28,"role":29},"Marit EM Sijbrandij, PhD","Full professor - Vrije Universiteit Amsterdam","PRINCIPAL_INVESTIGATOR",[31,36],{"name":32,"role":33,"phone":34,"phoneExt":18,"email":35},"Mathilde JF van Oudenaren, MSc","CONTACT","+3120-5981272","M.J.F.van.Oudenaren@vu.nl",{"name":37,"role":33,"phone":18,"phoneExt":18,"email":38},"Anke B Witteveen, PhD","A.B.Witteveen@vu.nl",[40],{"facility":41,"status":42,"city":43,"state":18,"zip":18,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Vrije Universiteit Amsterdam","RECRUITING","Amsterdam","Netherlands","NL",{"type":47,"coordinates":48},"Point",[49,50],4.88969,52.37403,{"lat":50,"lon":49},[53,55,57],{"name":54,"role":33,"phone":34,"phoneExt":18,"email":35},"Mathilde JF van Oudenaren",{"name":56,"role":33,"phone":18,"phoneExt":18,"email":38},"Anke B Witteveen",{"name":58,"role":29,"phone":18,"phoneExt":18,"email":18},"Marit EM Sijbrandij, full professor",{"type":29,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Mathilde van Oudenaren","PhD-student",[63],{"name":64,"class":65},"Netherlands Institute for the Study of Crime and Law Enforcement (NSCR)","UNKNOWN","100510557","feasibility-and-acceptability-of-problem-management-plus-pm-for-prisoners-in-the-netherlands---a-pilot-rct-100510557",false,"NCT05927987","Feasibility and Acceptability of Problem Management Plus (PM+) for Prisoners in the Netherlands - a Pilot RCT","Feasibility and Acceptability of Problem Management Plus (PM+) for Prisoners in the Netherlands - a Pilot Randomised Controlled Trial","PROSPER","Inclusion Criteria:\n\n* 18 years old or above;\n* Imprisoned in a Dutch prison;\n* Held on remand;\n* Dutch-speaking;\n* Elevated levels of psychological distress (K10 \\>15);\n\nExclusion Criteria:\n\n* Enclosed in a penitentiary psychiatric centre;\n* Presents a potential security risk to the research team (PM+ helper and\u002For research team)\n* Acute medical condition;\n* Imminent suicide risk or expressed acute needs\u002Fprotection risks (e.g., someone who expresses that they are at acute risk of being assaulted or killed);\n* Severe mental disorder (psychotic disorders, substance dependence) ;\n* Severe cognitive impairment (e.g., severe intellectual disability or dementia);\n* Currently enrolled in a specialised psychological treatment program (e.g., EMDR, CBT);\n* Less than two months on a stable dose of psychotropic medication (if applicable).","ALL","18 Years",{"count":77,"type":78},60,"ESTIMATED","INTERVENTIONAL",[81],"NA","The goal of this pilot randomised controlled trial is to evaluate the feasibility and acceptability of the - specifically to the prison context adapted - World Health Organization's Problem Management Plus (PM+) intervention for individuals detained in Dutch remand prisons. The main question\\[s\\] it aims to answer are:\n\n* To what extent is the contextually adapted PM+ intervention feasible and acceptable for individuals detained in Dutch remand prisons?\n* To what extent are there preliminary indications of pre to post-effects of the PM+ intervention on, for example, anxiety and depression symptoms?\n\nResearchers will compare two groups to answer these questions. Participants will either receive the PM+ intervention and Care-as-Usual or only Care-as-Usual.",[84,85,86],"Anxiety Disorders","Psychological Distress","Depressive Disorder",[88,89,90,91,92,93,94,95,96,97,98,85,99,100,101,102],"Pilot Randomised Controlled Trial","Pilot RCT","Prisoner","Remand Prisoner","Remand custody","Prison","Dutch prison","Dutch prisons","PM+","Problem Management Plus","WHO intervention","Anxiety Disorder","Depressive disorder","Common Mental Health problems","Common Mental Health disorders","2024-12-03",{"date":105,"type":106},"2024-12-05","ACTUAL",{"date":108,"type":106},"2024-06-13",{"date":110,"type":78},"2025-12-31",{"name":5,"class":6},1]