Our Whole Lives Gemini: Virtual Integrative Medical Group Visits for Managing Chronic Pain

Part of paid clinical trials in Malden, Massachusetts.

Sponsor
Cambridge Health Alliance
Study ID
NCT06515925
Status
Recruiting
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Conditions

  • Chronic Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Our Whole Lives (OWL) — 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. 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 — BEHAVIORAL
    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.

Study Details

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?

Key Dates

Start date
Aug 1, 2024
Status verified
Mar 2025
Primary completion
Sep 1, 2025
Completion
Nov 30, 2025

Study Design

Enrollment
212 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: 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).
  • Active Comparator: 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.

Primary Outcome Measure

Reduced pain impact (based on PROMIS 29) [ Time Frame: up to 24 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cambridge Health Alliance Center for Mindfulness and CompassionMaldenMassachusetts02458
Paula Gardiner
[email protected]
Alexandra Comeau
[email protected]
617-806-8735

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By research site
Cambridge Health Alliance Center for Mindfulness and Compassion· Malden, MA

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