[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100509686":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":65,"collaborators":67,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":76,"sex":82,"minAge":83,"maxAge":84,"enrollmentInfo":85,"targetDuration":26,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":94,"overallStatus":40,"whyStopped":26,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"Radboud University Medical Center","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention (LOS training) + care as usual (intervention group)","EXPERIMENTAL","Intervention group: mindfulness (LOS) training + CAU",[13,14],"Behavioral: Learning to Offset Stress (LOS) (in Dutch: Leren Omgaan met Stress) training","Behavioral: Care as usual",{"label":16,"type":17,"description":18,"interventionNames":19},"Care-as-usual (CAU)-only (control group)","ACTIVE_COMPARATOR","Control group: CAU-only",[14],[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BEHAVIORAL","Learning to Offset Stress (LOS) (in Dutch: Leren Omgaan met Stress) training","The investigational treatment is the LOS training, which is an adaptation of two previously validated mindfulness-based programs: Mindfulness-Based Cognitive Therapy (MBCT) developed by Segal, Williams, and Teasdale (2002) and the Mindful2Work (M2W) program developed by de Bruin, Formsma, and Bögels (2018). The M2W program combines mindful physical activity, yoga, and mindfulness meditation to target stress symptoms and burn-out in adults. The LOS training was adapted from these programs to meet the needs of youth with internalizing problems. The training consists of 8 weekly 2-hour sessions that each comprise three elements: mindful physical activity (15-20 minutes), yoga (15-20 minutes), and mindfulness meditation exercises (80-90 minutes). In addition to attending group sessions, participants are invited to practice at home on a daily basis. Home practice consists of daily mindfulness practices comprising mindfulness exercises, yoga and mindful physical activity.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Care as usual","Youth who seek help for internalizing problems from a primary mental health practitioner, including student psychologists or mental health nurse practioners, but do not (yet) meet criteria for (major) mental illness are typically offered supportive counselling, aimed primarily at helping people feel understood and supported. Supportive counselling may also include instructions on behavioral activation, particularly when individuals report reduced activity and behavioral avoidance including social withdrawal. In addition, mental health practitioners commonly employ a \"watchful waiting\" policy for people with symptoms in the milder range, where they check-in with clients on a regular basis and refer for more intensive treatment if and when symptoms worsen.",[16,9],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Guusje Collin, MD, PhD","CONTACT","+31 24 30 98988","guusje.collin@radboudumc.nl",[38,58],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Radboud university medical center (Radboudumc)","RECRUITING","Nijmegen","Gelderland","6500 HB","Netherlands","NL",{"type":47,"coordinates":48},"Point",[49,50],5.85278,51.8425,{"lat":50,"lon":49},[53,54],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},{"name":55,"role":34,"phone":56,"phoneExt":26,"email":57},"Paul Lagerweij, MSc","+31 6 50008497","paul.lagerweij@radboudumc.nl",{"facility":59,"status":60,"city":41,"state":42,"zip":61,"country":44,"countryCode":45,"cosmosGeoPoint":62,"geoPoint":64,"contacts":26},"Donders Centre for Cognitive Neuroimaging (DCCN)","ACTIVE_NOT_RECRUITING","6525 EN",{"type":47,"coordinates":63},[49,50],{"lat":50,"lon":49},{"type":66,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[68,70,72],{"name":69,"class":6},"Donders Centre for Cognitive Neuroimaging",{"name":71,"class":6},"ZonMw: The Netherlands Organisation for Health Research and Development",{"name":73,"class":6},"Brain & Behavior Research Foundation","100509686","promoting-resilience-in-youth-through-mindfulness-meditation-100509686",false,"NCT05916651","Promoting Resilience in Youth Through Mindfulness mEditation","The PRYME Study: Promoting Resilience in Youth Through Mindfulness mEditation.","PRYME","Inclusion Criteria:\n\n1. Youth between 16 and 25 years of age\n2. Provide written informed consent\n3. Adequate mastery of Dutch language\n\nExclusion Criteria:\n\n1. Lifetime diagnosis of severe major depression, bipolar disorder, schizophrenia spectrum disorder, personality disorder, and post-traumatic stress disorder\n2. History of major medical illness or neurological illness\n3. Participation in a mindfulness programme in the past year\n4. Current participation in another intervention study\n5. Moderate to severe substance use disorders (i.e., we will allow for mild substance use)\n6. Current active suicidality, current psychotic symptoms above clinical cut-off for psychosis, or current trauma-related complaints above clinical cut-off for PTSD.\n7. Diagnosed or suspected (mild) intellectual disability (estimated IQ \\\u003C 75)","ALL","16 Years","25 Years",{"count":86,"type":87},155,"ESTIMATED","INTERVENTIONAL",[90],"NA","The aim of this randomized controlled trial (RCT) is to assess whether mindfulness training reduces early stage internalizing problems such as anxiety, worrying, and low mood in help-seeking youth.\n\nParticipants will be randomly assigned to one of two groups: 1) mindfulness + care-as-usual (CAU) or 2) CAU-only. The mindfulness program was developed specifically for youth with internalizing problems. The 8-week training program consists of weekly 2-hour sessions, with mindfulness, yoga, and mindful active movement in each session. In addition, participants are invited to practice at home in between sessions for around 20 minutes per day.\n\nData will be collected at baseline (T0), end-of-treatment (T1) (or 2-3 months after baseline for the CAU-only group), and at 2 months follow-up (T2) and 6 months follow-up (T3).\n\nMeasurements will include:\n\n* Self-report questionnaires (T0, T1, T2, T3)\n* Psychiatric diagnostic interview (T0, T3)\n* MRI scans (T0, T1)\n* Cognitive tasks (T0, T1)\n\nThe primary outcome parameter is the total number of internalizing problems measured with the Adult Self Report (ASR) at end-of-treatment. The effect of mindfulness training (mindfulness + CAU vs. CAU-only) on internalizing problems at T1 will be assessed using a linear-mixed effects model.",[93],"Internalizing Problems",[95,96,97,98,99,100],"mindfulness","internalizing problems","self-referential processing","youth","help-seeking","resilience","2024-12-09",{"date":103,"type":104},"2024-12-13","ACTUAL",{"date":106,"type":104},"2023-07-07",{"date":108,"type":87},"2026-07-01",{"name":5,"class":6},2]