Virtual group visits for managing chronic pain
Phase II: GEMINI: Virtual Integrative Medical Group Visits for Managing Chronic Pain
This study tests whether a new online program that includes mindfulness group sessions can help people with chronic pain manage their symptoms better than those who use it less.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 212 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Cambridge Health Alliance Academic / other |
| Locations | 1 site (Malden, Massachusetts) |
| Trial ID | NCT06515925 on ClinicalTrials.gov |
What this trial studies
This research aims to evaluate the effectiveness of a web-based platform designed for chronic pain management, focusing on mindfulness techniques. Participants will engage in a 9-week program that includes access to the Our Whole Lives (OWL) e-health platform and weekly live-online mindfulness group sessions. The study will compare outcomes between a group receiving full engagement with OWL and a control group with minimal engagement. Follow-up surveys and optional interviews will assess the impact of the intervention on pain management and related outcomes.
Who should consider this trial
Good fit: Ideal candidates are English-speaking adults over 18 experiencing chronic musculoskeletal pain with an average pain intensity of 4 or higher.
Not a fit: Patients with severe depression, active substance abuse, or serious underlying conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance self-management of chronic pain for patients.
How similar studies have performed: Other studies have shown promise in using mindfulness and web-based interventions for chronic pain management, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Malden, Massachusetts
- Cambridge Health Alliance Center for Mindfulness and Compassion — Malden, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Paula Gardiner, MD, MPH — Cambridge Health Alliance
- Study coordinator: Paula Gardiner
- Email: pgardiner@challiance.org
- Phone: 617 806 8735
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.