Clinical trial NCT06515925: Our Whole Lives Gemini: Virtual Integrative Medical Group Visits for Managing Chronic Pain
Official title: Phase II: GEMINI: Virtual Integrative Medical Group Visits for Managing Chronic Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Pain
Lead sponsor: Cambridge Health Alliance
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
name: BrightOutcome
First posted: 2024-07-23
Enrollment: 212
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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: 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

Primary outcomes:
measure: Reduced pain impact (based on PROMIS 29)
timeFrame: up to 24 weeks
Secondary outcomes:
measure: The Patient-Reported Outcomes Measurement Information System (PROMIS 29)
timeFrame: up to 24 weeks
measure: Pain Self- Efficacy Scale (PSEQ)
timeFrame: up to 24 weeks
measure: Timeline Follow-Back (TLFB)
timeFrame: up to 24 weeks
Other outcomes:
Locations:
city: Malden
country: United States
facility: Cambridge Health Alliance Center for Mindfulness and Compassion
state: Massachusetts
Study officials:
affiliation: Cambridge Health Alliance
name: Zev Schuman-Olivier, MD
role: STUDY_DIRECTOR
affiliation: Cambridge Health Alliance
name: Paula Gardiner, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: BrightOutcome
name: Niina Haas, PHD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Deyo RA, Katrina Ramsey, Buckley DI, Michaels L, Kobus A, Eckstrom E, Forro V, Morris C. Performance of a Patient Reported Outcomes Measurement Information System (PROMIS) Short Form in Older Adults with Chronic Musculoskeletal Pain. Pain Med. 2016 Feb;17(2):314-24. doi: 10.1093/pm/pnv046.
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citation: Sobell LC, Sobell MB. Timeline follow-back. Measuring alcohol consumption. Springer;1992:41-72.
citation: Fals-Stewart W, O'Farrell TJ, Freitas TT, McFarlin SK, Rutigliano P. The timeline followback reports of psychoactive substance use by drug-abusing patients: psychometric properties. J Consult Clin Psychol. 2000 Feb;68(1):134-44. doi: 10.1037//0022-006x.68.1.134.