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

March 12, 2025 updated by: Cambridge Health Alliance

Phase II: GEMINI: Virtual Integrative Medical Group Visits for Managing Chronic Pain

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?

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

212

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Our Whole Lives (OWL)
Our Whole Lives (OWL) is a 9-week online curriculum on the GEMINI platform. OWL is a nine-session, web-accessible, self-paced mindfulness curriculum that has interactive components of self-monitoring and social support (online community).
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.
Active Comparator: Low Dose Mindfulness Training
The GEMINI platform will facilitate the delivery of a low-dose mindfulness version of Our Whole Lives program. Participants will interface with the GEMINI platform's static content.
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.
Other Names:
  • Low dose comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduced pain impact (based on PROMIS 29)
Time Frame: up to 24 weeks
The primary trial aim is to reduce pain impact.
up to 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Timeline Follow-Back (TLFB)
Time Frame: up to 24 weeks
Use of pain meds in the previous 7 days, including opioid use.
up to 24 weeks
The Patient-Reported Outcomes Measurement Information System (PROMIS 29)
Time Frame: up to 24 weeks
Depression and Anxiety in the past 7 days. Fatigue in the past 7 days. Sleep disturbance in the past 7 days. Ability to Participate in Social roles, and activities. Each item within is measured on a 5-point scale, 1 (minimum) to 5(maximum). Higher T-scores in some domains indicate better health; in others, they indicate worse symptoms.
up to 24 weeks
Pain Self- Efficacy Scale (PSEQ)
Time Frame: up to 24 weeks
Self-efficacy beliefs for pain management. 10 items measured on a 6-point scale, 0 (minimum) to 6(maximum). Higher scores indicate greater pain self-efficacy.
up to 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cambridge Health Alliance

Collaborators

National Center for Complementary and Integrative Health (NCCIH)
BrightOutcome

Investigators

  • Study Director: Zev Schuman-Olivier, MD, Cambridge Health Alliance
  • Principal Investigator: Paula Gardiner, MD, MPH, Cambridge Health Alliance
  • Principal Investigator: Niina Haas, PHD, BrightOutcome

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2024

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

November 30, 2025

Study Registration Dates

First Submitted

July 17, 2024

First Submitted That Met QC Criteria

July 17, 2024

First Posted (Actual)

July 23, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 12, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHA-IRB-23-24-260
  • 1R44AT012302-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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