NCT06515925 · Cambridge Health Alliance
Our Whole Lives Gemini: Virtual Integrative Medical Group Visits for Managing Chronic Pain
What this study is about
The goal of this research study is to test the effectiveness of a non-prescription medicine, web-based platform solution for patients with chronic pain, to improve pain self-management and related outcomes.
View original scientific description
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.
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.
Primary outcome measures
Reduced pain impact (based on PROMIS 29)
Time frame: up to 24 weeks
The primary trial aim is to reduce pain impact.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Malden, Massachusetts
Collaborators
National Center for Complementary and Integrative Health (NCCIH), BrightOutcome
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 13, 2025 · Source of record for eligibility and locations