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NCT Number: NCT06515925

Our Whole Lives 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?

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cambridge Health Alliance Center for Mindfulness and Compassion

Malden, Massachusetts, 02458, United States

Location status: Recruiting

Location contact

Alexandra Comeau

CONTACT

[email protected]

617-806-8735

Paula Gardiner

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Our Whole Lives (OWL)

Behavioral

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.

Low Dose Mindfulness Training

Behavioral

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

Primary outcomes

  1. Reduced pain impact (based on PROMIS 29)

    Time frame: up to 24 weeks

    The primary trial aim is to reduce pain impact.

Secondary outcomes

  1. 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.

  2. 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.

  3. Timeline Follow-Back (TLFB)

    Time frame: up to 24 weeks

    Use of pain meds in the previous 7 days, including opioid use.

Study contacts

Contact information is provided by the study sponsor or research team.

Alexandra Comeau

CONTACT

[email protected]

617-806-8735

Paula Gardiner

CONTACT

[email protected]

617 806 8735

Sponsors and collaborators

Lead sponsor

Cambridge Health Alliance

Other

Collaborators

  • BrightOutcome
  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 23, 2024
Registry last updated
Mar 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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