[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100555733":3},{"organization":4,"outcomesModule":7,"designInfo":24,"detailedDescription":34,"studyPopulation":23,"armGroups":35,"interventions":48,"overallOfficials":58,"centralContacts":68,"locations":78,"responsibleParty":96,"collaborators":98,"id":104,"slug":23,"hasResults":105,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":23,"eligibilityCriteria":109,"healthyVolunteers":105,"sex":110,"minAge":111,"maxAge":23,"enrollmentInfo":112,"targetDuration":23,"studyType":115,"phases":116,"briefSummary":118,"conditions":119,"keywords":23,"overallStatus":81,"whyStopped":23,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":130},{"fullName":5,"class":6},"Cambridge Health Alliance","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":23},[9],{"measure":10,"description":11,"timeFrame":12},"Reduced pain impact (based on PROMIS 29)","The primary trial aim is to reduce pain impact.","up to 24 weeks",[14,17,20],{"measure":15,"description":16,"timeFrame":12},"The Patient-Reported Outcomes Measurement Information System (PROMIS 29)","Depression and Anxiety in the past 7 days. Fatigue in the past 7 days. Sleep disturbance in the past 7 days. Ability to Participate in Social roles, and activities. Each item within is measured on a 5-point scale, 1 (minimum) to 5(maximum). Higher T-scores in some domains indicate better health; in others, they indicate worse symptoms.",{"measure":18,"description":19,"timeFrame":12},"Pain Self- Efficacy Scale (PSEQ)","Self-efficacy beliefs for pain management. 10 items measured on a 6-point scale, 0 (minimum) to 6(maximum). Higher scores indicate greater pain self-efficacy.",{"measure":21,"description":22,"timeFrame":12},"Timeline Follow-Back (TLFB)","Use of pain meds in the previous 7 days, including opioid use.",null,{"allocation":25,"interventionModel":26,"interventionModelDescription":23,"primaryPurpose":27,"observationalModel":23,"timePerspective":23,"maskingInfo":28},"RANDOMIZED","PARALLEL","SUPPORTIVE_CARE",{"masking":29,"maskingDescription":23,"whoMasked":30},"TRIPLE",[31,32,33],"PARTICIPANT","INVESTIGATOR","OUTCOMES_ASSESSOR","This study has 6 mandatory components and 1 optional component:\n\n* Recruitment Screening Call\n* Informed Consent Session\n* Baseline Survey Session\n* Intervention: Engagement with the Our Whole Lives (OWL) an e-health platform: For 9 weeks, participants will all have access to a mindfulness program within OWL, optimized for people with chronic pain.\n* Live-Online Mindfulness Group weekly\n* Control: Low dose engagement with OWL with no group engagement.\n* Follow-Up Survey Sessions at Week 10, Week 16, and Week 24.\n* Online Focus Group\u002FIndividual Interview. Participants will be asked to participate in an OPTIONAL individual interview, or a one-hour focus group with other participants in the study who used the OWL website as well.\n\nResearchers will compare two groups that will be using the web-based platform. Each group will have different engagement content from the web-based platform and investigators will see if it affects overall chronic pain and pain management.",[36,42],{"label":37,"type":38,"description":39,"interventionNames":40},"Our Whole Lives (OWL)","EXPERIMENTAL","Our Whole Lives (OWL) is a 9-week online curriculum on the GEMINI platform. OWL is a nine-session, web-accessible, self-paced mindfulness curriculum that has interactive components of self-monitoring and social support (online community).",[41],"Behavioral: Our Whole Lives (OWL)",{"label":43,"type":44,"description":45,"interventionNames":46},"Low Dose Mindfulness Training","ACTIVE_COMPARATOR","The GEMINI platform will facilitate the delivery of a low-dose mindfulness version of Our Whole Lives program. Participants will interface with the GEMINI platform's static content.",[47],"Behavioral: Low Dose Mindfulness Training",[49,53],{"type":50,"name":37,"description":51,"armGroupLabels":52,"otherNames":23},"BEHAVIORAL","OWL is a nine-session, web-accessible, self-paced mindfulness curriculum that has interactive components of self-monitoring and social support (online community). Our Whole Lives (OWL) online curriculum of self-management topics such as mindfulness, mind-body practices, education about chronic pain therapies, stress reduction, sleep, and nutrition.\n\nOnce a week for 9 weeks participants will attend a 1.5 -2-hour online group session via Zoom or Google Meets, accessing it through GEMINI platform.",[37],{"type":50,"name":43,"description":54,"armGroupLabels":55,"otherNames":56},"The GEMINI platform will facilitate the delivery of a low-dose version of Our Whole Lives program. OWL in this arm is a nine-session, web-accessible, self-paced curriculum, self-monitoring. Participants will interface with the GEMINI platform's static content.",[43],[57],"Low dose comparator",[59,62,65],{"name":60,"affiliation":5,"role":61},"Zev Schuman-Olivier, MD","STUDY_DIRECTOR",{"name":63,"affiliation":5,"role":64},"Paula Gardiner, MD, MPH","PRINCIPAL_INVESTIGATOR",{"name":66,"affiliation":67,"role":64},"Niina Haas, PHD","BrightOutcome",[69,74],{"name":70,"role":71,"phone":72,"phoneExt":23,"email":73},"Paula Gardiner","CONTACT","617 806 8735","pgardiner@challiance.org",{"name":75,"role":71,"phone":76,"phoneExt":23,"email":77},"Alexandra Comeau","617-806-8735","acomeau@challiance.org",[79],{"facility":80,"status":81,"city":82,"state":83,"zip":84,"country":85,"countryCode":86,"cosmosGeoPoint":87,"geoPoint":92,"contacts":93},"Cambridge Health Alliance Center for Mindfulness and Compassion","RECRUITING","Malden","Massachusetts","02458","United States","US",{"type":88,"coordinates":89},"Point",[90,91],-71.06616,42.4251,{"lat":91,"lon":90},[94,95],{"name":70,"role":71,"phone":23,"phoneExt":23,"email":73},{"name":75,"role":71,"phone":76,"phoneExt":23,"email":77},{"type":97,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR",[99,102],{"name":100,"class":101},"National Center for Complementary and Integrative Health (NCCIH)","NIH",{"name":67,"class":103},"INDUSTRY","100555733",false,"NCT06515925","Our Whole Lives Gemini: Virtual Integrative Medical Group Visits for Managing Chronic Pain","Phase II: GEMINI: Virtual Integrative Medical Group Visits for Managing Chronic Pain","Inclusion Criteria:\n\n* English-speaking adults\n* Over the age of 18\n* Experiencing chronic musculoskeletal pain. (Pain may have more than one source; Pain must be non-malignant; Participant must have an average pain intensity of ≥ 4 (1 out of 10) in the past 7 days; Participant must meet the chronic criteria of a pain problem that has persisted at least 3 months, and has resulted in pain on at least half the days in the past 6 months)\n\nExclusion Criteria:\n\n* Inability to understand English at a level necessary for informed consent and understanding participation instructions, and participating in the group;\n* Serious underlying systemic or co-morbid conditions or life event that precludes physical or cognitive ability to participate in the study.\n* Severe depression\n* Current mania or psychosis;\n* Active heroin or cocaine use in the past 3 months\n* Heavy alcohol use\n* Known or planned pregnancy","ALL","18 Years",{"count":113,"type":114},212,"ESTIMATED","INTERVENTIONAL",[117],"NA","The goal of this research study is to test the efficacy of a non-prescription medicine, web-based platform solution for patients with chronic pain, to improve pain self-management and related outcomes. The main question investigators aim to answer is; would the use of this web-based intervention plus an online group visit compared to control result in better pain-related outcomes and improved pain impact?",[120],"Chronic Pain","2025-03-12",{"date":123,"type":124},"2025-03-13","ACTUAL",{"date":126,"type":124},"2024-08-01",{"date":128,"type":114},"2025-11-30",{"name":5,"class":6},1]