NCT06515925NARecruiting

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

Cambridge Health Alliance

Start Date

8/1/2024

Completion Date

11/30/2025

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.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * English-speaking adults * 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: * Inability to understand English at a level necessary for informed consent and understanding participation instructions, and participating in the group; * 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

Interventions

BEHAVIORAL

Our Whole Lives (OWL)

BEHAVIORAL

Low Dose Mindfulness Training

Interested in This Trial?

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Conditions

Chronic Pain

Locations

Cambridge Health Alliance Center for Mindfulness and Compassion

Malden, Massachusetts 02458

United States