Our Whole Lives Gemini: Virtual Integrative Medical Group Visits for Managing Chronic Pain
NCT ID: NCT06515925
Last Updated: 2025-03-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
212 participants
INTERVENTIONAL
2024-08-01
2025-11-30
Brief Summary
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Detailed Description
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* Recruitment Screening Call
* Informed Consent Session
* Baseline Survey Session
* 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.
* Live-Online Mindfulness Group weekly
* Control: Low dose engagement with OWL with no group engagement.
* Follow-Up Survey Sessions at Week 10, Week 16, and Week 24.
* Online Focus Group/Individual 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.
Researchers 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
TRIPLE
Study Groups
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Our Whole Lives (OWL)
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).
Our Whole Lives (OWL)
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.
Once 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.
Low Dose Mindfulness Training
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.
Low Dose Mindfulness Training
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.
Interventions
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Our Whole Lives (OWL)
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.
Once 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.
Low Dose Mindfulness Training
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Over the age of 18
* 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)
Exclusion Criteria
* Serious underlying systemic or co-morbid conditions or life event that precludes physical or cognitive ability to participate in the study.
* Severe depression
* Current mania or psychosis;
* Active heroin or cocaine use in the past 3 months
* Heavy alcohol use
* Known or planned pregnancy
18 Years
ALL
No
Sponsors
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National Center for Complementary and Integrative Health (NCCIH)
NIH
BrightOutcome
INDUSTRY
Cambridge Health Alliance
OTHER
Responsible Party
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Principal Investigators
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Zev Schuman-Olivier, MD
Role: STUDY_DIRECTOR
Cambridge Health Alliance
Paula Gardiner, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Cambridge Health Alliance
Niina Haas, PHD
Role: PRINCIPAL_INVESTIGATOR
BrightOutcome
Locations
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Cambridge Health Alliance Center for Mindfulness and Compassion
Malden, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Deyo RA, Dworkin SF, Amtmann D, Andersson G, Borenstein D, Carragee E, Carrino J, Chou R, Cook K, DeLitto A, Goertz C, Khalsa P, Loeser J, Mackey S, Panagis J, Rainville J, Tosteson T, Turk D, Von Korff M, Weiner DK. Report of the NIH Task Force on research standards for chronic low back pain. J Pain. 2014 Jun;15(6):569-85. doi: 10.1016/j.jpain.2014.03.005. Epub 2014 Apr 29.
Deyo RA, Katrina Ramsey, Buckley DI, Michaels L, Kobus A, Eckstrom E, Forro V, Morris C. Performance of a Patient Reported Outcomes Measurement Information System (PROMIS) Short Form in Older Adults with Chronic Musculoskeletal Pain. Pain Med. 2016 Feb;17(2):314-24. doi: 10.1093/pm/pnv046.
Nicholas MK. The pain self-efficacy questionnaire: Taking pain into account. Eur J Pain. 2007 Feb;11(2):153-63. doi: 10.1016/j.ejpain.2005.12.008. Epub 2006 Jan 30.
Sobell LC, Sobell MB. Timeline follow-back. Measuring alcohol consumption. Springer;1992:41-72.
Fals-Stewart W, O'Farrell TJ, Freitas TT, McFarlin SK, Rutigliano P. The timeline followback reports of psychoactive substance use by drug-abusing patients: psychometric properties. J Consult Clin Psychol. 2000 Feb;68(1):134-44. doi: 10.1037//0022-006x.68.1.134.
Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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CHA-IRB-23-24-260
Identifier Type: -
Identifier Source: org_study_id
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