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

NCT06515925 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 212

Last updated 2025-03-13

No results posted yet for this study

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?

Conditions

Interventions

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.

Sponsors & Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

    collaborator NIH

  • BrightOutcome

    collaborator INDUSTRY

  • Cambridge Health Alliance

    lead OTHER

Principal Investigators

  • Zev Schuman-Olivier, MD · Cambridge Health Alliance

  • Paula Gardiner, MD, MPH · Cambridge Health Alliance

  • Niina Haas, PHD · BrightOutcome

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-01
Primary Completion
2025-09-01
Completion
2025-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06515925 on ClinicalTrials.gov