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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 212 (estimated)
• Sponsor: Cambridge Health Alliance · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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?

Detailed description

This study has 6 mandatory components and 1 optional component: * 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

• Chronic Pain

Interventions

Type	Name	Description
BEHAVIORAL	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.
BEHAVIORAL	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.

Timeline

• Start date: 2024-08-01
• Primary completion: 2025-09-01
• Completion: 2025-11-30
• First posted: 2024-07-23
• Last updated: 2025-03-13

Locations

1 site across 1 country: United States