[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100575764":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":29,"centralContacts":34,"locations":39,"responsibleParty":54,"collaborators":56,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":69,"maxAge":22,"enrollmentInfo":70,"targetDuration":22,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":82,"overallStatus":41,"whyStopped":22,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"University of Zurich","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention group","EXPERIMENTAL","The participants who are assigned to the intervention group will receive five sessions of PM+, a psychological intervention which has been developed by the WHO. PM+ is a short, transdiagnostic (i.e., not specifically aimed at treating a certain mental disorder) program aiming to reduce common mental health symptoms and improve psychosocial functioning. In addition, participants will receive three telephone booster sessions and are provided with handouts and homework reminders.",[13],"Behavioral: Problem Management Plus",{"label":15,"type":6,"description":16,"interventionNames":17},"waitlist control group","The control group will receive the augmented PM+ intervention 12 months after the baseline assessment.",[13],{"label":19,"type":20,"description":21,"interventionNames":22},"observational control group","NO_INTERVENTION","Participants who scored below 20 on the K10 will will only be part of the baseline assessments and receive no intervention.",null,[24],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":22},"BEHAVIORAL","Problem Management Plus","Problem Management Plus (PM+) is a brief, psychological intervention program based on CBT techniques that are empirically supported and formally recommended by the WHO. 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 plus stress management, behavioural activation, and accessing social support. These elements have been recommended in recent WHO guidelines.\n\nAdditionally, the original five PM+ sessions will be augmented in two ways. First, the participants will receive three 30-45-minutes telephone booster sessions 10, 22, and 34 weeks after the final original PM+ session. The second augmentation strategy involves handouts and homework reminders.",[9,15],[30],{"name":31,"affiliation":32,"role":33},"Naser Morina, PD Dr.","Klinik für Konsiliarpsychiatrie und Psychosomatik","PRINCIPAL_INVESTIGATOR",[35],{"name":31,"role":36,"phone":37,"phoneExt":22,"email":38},"CONTACT","+41 44 255 5280","naser.morina@usz.ch",[40],{"facility":32,"status":41,"city":42,"state":22,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"RECRUITING","Zurich","8091","Switzerland","CH",{"type":47,"coordinates":48},"Point",[49,50],8.55,47.36667,{"lat":50,"lon":49},[53],{"name":31,"role":36,"phone":37,"phoneExt":22,"email":38},{"type":55,"investigatorFullName":22,"investigatorTitle":22,"investigatorAffiliation":22,"oldNameTitle":22,"oldOrganization":22},"SPONSOR",[57,59],{"name":58,"class":6},"ETH Zurich",{"name":60,"class":6},"The University of New South Wales","100575764","boosting-refugee-integration-through-psychological-intervention-100575764",false,"NCT06776523","Boosting Refugee Integration Through Psychological Intervention","BRIGHT","The inclusion criteria for participating in the study are:\n\n* refugees and asylum seekers (RAS) aged 16 or older;\n* residing in one of the participating local sites (Swiss municipalities, namely, Gemeinden, and transitional asylum centers, namely, Durchgangszentren) where PM+ is offered and which gave their consent for participation in the RCT;\n* speaking at least one of the following 12 languages: German, English, French, Arabic, Farsi, Kurdish, Tigrinya, Turkish, Ukrainian, Russian, Tamil, and Pashto;\n* obtaining a score of 20 or higher on the Kessler Psychological Distress Scale (K10; Kessler et al., 2002), a brief clinically validated screening questionnaire that assesses general psychological distress in the past 30 days. A score equal to or higher than 20 is used as an indication of moderate to high levels of psychological distress.\n\nThe exclusion criteria for participating in the study are:\n\n* significant cognitive or neurological impairment measured through specific tools developed by the WHO and integrated into the PM+ manual (impairment questionnaire);\n* acute medical conditions or severe mental disorders (e.g., psychotic or substance-abuse disorders) measured through specific tools developed by the WHO and integrated into the PM+ manual (impairment questionnaire);\n* acute risk of suicide as measured by the Suicidal Ideation Attribution Scale (SIDAS; van Spijker et al., 2014) and the Thoughts of Suicide Questionnaire (World Health Organization WHO, 2016).","ALL","16 Years",{"count":71,"type":72},1200,"ESTIMATED","INTERVENTIONAL",[75],"NA","Refugees and asylum seekers (RAS) face numerous stressors and adversities which put them at risk for developing mental health problems. However, access to adequate mental health care in host countries is limited. To address this problem, the World Health Organization (WHO) introduced Problem Management Plus (PM+), a short, low-intensity psychological intervention administered by non-professionals, aiming to alleviate common mental disorders among crisis-affected communities.\n\nThe present study aims at expanding the existing PM+ intervention by providing additional booster sessions and homework reminders while evaluating its effectiveness and implementation in the public health system.",[78,79,80,81],"Psychological Distress","PTSD","Trauma","Common Mental Health Problems",[26,78,83,84],"Mental Health Care","Refugees","2026-04-21",{"date":87,"type":88},"2026-04-27","ACTUAL",{"date":90,"type":88},"2025-01-16",{"date":92,"type":72},"2027-09",{"name":5,"class":6},1]