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

Last updated: March 12, 2025
Sponsor: Cambridge Health Alliance
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pain

Chronic Pain

Treatment

Our Whole Lives (OWL)

Low Dose Mindfulness Training

Clinical Study ID

NCT06515925
CHA-IRB-23-24-260
1R44AT012302-01A1
  • Ages > 18
  • All Genders

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?

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • English-speaking adults

  • Over the age of 18

  • Experiencing chronic musculoskeletal pain. (Pain may have more than one source; Painmust be non-malignant; Participant must have an average pain intensity of ≥ 4 (1 outof 10) in the past 7 days; Participant must meet the chronic criteria of a painproblem that has persisted at least 3 months, and has resulted in pain on at leasthalf the days in the past 6 months)

Exclusion

Exclusion Criteria:

  • Inability to understand English at a level necessary for informed consent andunderstanding participation instructions, and participating in the group;

  • Serious underlying systemic or co-morbid conditions or life event that precludesphysical 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

Study Design

Total Participants: 212
Treatment Group(s): 2
Primary Treatment: Our Whole Lives (OWL)
Phase:
Study Start date:
August 01, 2024
Estimated Completion Date:
November 30, 2025

Study 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.

Connect with a study center

  • Cambridge Health Alliance Center for Mindfulness and Compassion

    Malden, Massachusetts 02458
    United States

    Active - Recruiting

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