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

Not Applicable

Recruiting

• Conditions: Chronic Pain
• Interventions: Behavioral: Low Dose Mindfulness Training; Behavioral: Our Whole Lives (OWL)

• Registration Number: NCT06515925
• Lead Sponsor: Cambridge Health Alliance

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.

Study Timeline

• Study First Submitted: 2024-07-17
• Study First Submitted QC: 2024-07-17
• Study First Posted: 2024-07-23
• Study Start: 2024-08-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-12
• Last Update Posted: 2025-03-13
• Primary Completion: 2025-09-01
• Study Completion: 2025-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 212

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low Dose Mindfulness Training	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.
Our Whole Lives (OWL)	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).

Primary Outcome Measures

Name	Time	Method
Reduced pain impact (based on PROMIS 29)	up to 24 weeks	The primary trial aim is to reduce pain impact.

Secondary Outcome Measures

Name	Time	Method
Timeline Follow-Back (TLFB)	up to 24 weeks	Use of pain meds in the previous 7 days, including opioid use.
The Patient-Reported Outcomes Measurement Information System (PROMIS 29)	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.
Pain Self- Efficacy Scale (PSEQ)	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.

Trial Locations

Locations (1)

Cambridge Health Alliance Center for Mindfulness and Compassion; 🇺🇸 Malden, Massachusetts, United States