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

Cambridge Health Alliance

Status: Enrolling

Conditions: Chronic Pain

Treatments: Behavioral: Low Dose Mindfulness Training; Behavioral: Our Whole Lives (OWL)

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT06515925

1R44AT012302-01A1 (U.S. NIH Grant/Contract)

CHA-IRB-23-24-260

Details and patient eligibility

About

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?

Full 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.

Enrollment: 212 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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212 participants in 2 patient groups

Our Whole Lives (OWL)

Experimental group

Description:

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).

Treatment:

Behavioral: Our Whole Lives (OWL)

Low Dose Mindfulness Training

Active Comparator group

Description:

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.

Treatment:

Behavioral: Low Dose Mindfulness Training