[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100592224":3},{"organization":4,"outcomesModule":7,"designInfo":33,"detailedDescription":42,"studyPopulation":32,"armGroups":43,"interventions":56,"overallOfficials":32,"centralContacts":64,"locations":32,"responsibleParty":70,"collaborators":74,"id":77,"slug":32,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":45,"eligibilityCriteria":82,"healthyVolunteers":78,"sex":83,"minAge":84,"maxAge":85,"enrollmentInfo":86,"targetDuration":32,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":96,"overallStatus":101,"whyStopped":32,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":32},{"fullName":5,"class":6},"University of Coimbra","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":22,"otherOutcomes":32},[9,13,16,19],{"measure":10,"description":11,"timeFrame":12},"Pain intensity","\\- The Numeric Rating Scale (NRS)","From enrollment to the end of treatment at 8 weeks",{"measure":14,"description":15,"timeFrame":12},"Pain Impact","\\- Pain Disability Index (PDI)",{"measure":17,"description":18,"timeFrame":12},"Mental Health","Mental Health:\n\n\\- Depression Anxiety and Stress Scale (DASS-21)",{"measure":20,"description":21,"timeFrame":12},"Psychological and Physical Quality of Life","\\- World Health Organization Quality of Life - Bref (WHOQOL- Bref)",[23,26,29],{"measure":24,"description":25,"timeFrame":12},"Mindful Awareness","Mindful Awareness:\n\n\\- Mindful Attention Awareness Scale (MAAS)",{"measure":27,"description":28,"timeFrame":12},"Emotional Regulation","Emotional Regulation:\n\n\\- Difficulties in Emotion Regulation Scale - Short Form (DERS-SF)",{"measure":30,"description":31,"timeFrame":12},"Psychological Flexibility","Psychological Flexibility:\n\n\\- Comprehensive Assessment of Acceptance and Commitment Therapy Processes (CompACT)",null,{"allocation":34,"interventionModel":35,"interventionModelDescription":32,"primaryPurpose":36,"observationalModel":32,"timePerspective":32,"maskingInfo":37},"RANDOMIZED","PARALLEL","SUPPORTIVE_CARE",{"masking":38,"maskingDescription":32,"whoMasked":39},"DOUBLE",[40,41],"PARTICIPANT","OUTCOMES_ASSESSOR","This project has three objectives: O1) to develop and test the feasibility and acceptability of a 8-week VR ACT program (VR-ACT) in a sample of CPSP patients; O2) to pilot test the efficacy of VR-ACT in improving pain, mental health, and adaptive psychological processes and skills, and in reducing the functional connectivity of the Triple Network (DMN, SN, and FPN); O3) To examine the cost-effectiveness of the VR-ACT. The current project will conduct a parallel group design Randomized Controlled Trial (RCT) and will follow a multi-method approach (qualitative and quantitative assessment).",[44,50],{"label":45,"type":46,"description":47,"interventionNames":48},"VR-ACT","EXPERIMENTAL","8 modules of 3D immersive skills training (2 targeting awareness regulation skills; 3 promoting acceptance; 3 focused on behavioral change and commitment to valued action)",[49],"Behavioral: VR-ACT",{"label":51,"type":52,"description":53,"interventionNames":54},"Sham-VR","SHAM_COMPARATOR","8 2D non-immersive distracting video animations delivered through a VR headset",[55],"Behavioral: Sham-VR",[57,61],{"type":58,"name":45,"description":59,"armGroupLabels":60,"otherNames":32},"BEHAVIORAL","8 MODULES OF 3D VIRTUAL REALITY Modules 1 \\& 2: Awareness Regulation Skills Modules 3, 4 \\& 5: Acceptance of Pain and Internal Experiences Modules 6, 7 \\& 8: Behavior Change and Valued Action",[45],{"type":58,"name":51,"description":62,"armGroupLabels":63,"otherNames":32},"8 2D non-immersive distracting video-animations delivered through a VR headset.",[51],[65],{"name":66,"role":67,"phone":68,"phoneExt":32,"email":69},"Sérgio A Carvalho, PhD","CONTACT","+351 239 851 450","sergiocarvalho@fpce.uc.pt",{"type":71,"investigatorFullName":72,"investigatorTitle":73,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"PRINCIPAL_INVESTIGATOR","Sérgio Andrade Carvalho","Doctor",[75],{"name":76,"class":6},"Unidade Local de Saúde de Coimbra, EPE","100592224",false,"NCT06990646","VR-ACT After Stroke: a Feasibility Study","VR-ACT After Stroke: a Feasibility RCT of a Virtual Reality Delivery of ACT for Pain Management and Mental Health in Patients With Chronic Post-Stroke Pain","Inclusion Criteria:\n\n* medical diagnosis of CPSP;\n* age between 18 and 80;\n* implicit de facto internet and computer literacy;\n* willingness to comply with the study procedures.\n\nExclusion Criteria:\n\n* currently with active malignancy; -\n* severe cognitive impairment;\n* currently undergoing any psychological intervention or VR-delivered pain management program;\n* current severe psychiatric symptoms (i.e., psychosis; severe depression; non-suicidal self-injury; suicide attempt in the last month);\n* language impairment with severe comprehension deficit;\n* history of photosensitive epilepsy or previous experience of severe simulator sickness;\n* other neurological conditions (e.g., dementia; Parkinson´s).","ALL","18 Years","80 Years",{"count":87,"type":88},30,"ESTIMATED","INTERVENTIONAL",[91],"NA","This exploratory project aims to develop and pilot test, in a parallel group randomized controlled trial (RCT) design, the feasibility, acceptability, and preliminary efficacy of a self-management virtual reality (VR) 8-week program for pain management and mental health in patients with chronic post-stroke pain (CPSP), in two assessment moments (pre- to post-intervention).",[94,95],"Chronic Pain","Stroke",[97,98,99,100],"chronic post-stroke pain","contextual-behavioral approaches","virtual reality","acceptance and commitment therapy","NOT_YET_RECRUITING","2025-05-21",{"date":104,"type":105},"2025-05-25","ACTUAL",{"date":107,"type":88},"2025-11",{"date":109,"type":88},"2026-07",{"name":5,"class":6}]