Recruiting

Integrative Medical Group Visits

Sponsor:

Cambridge Health Alliance

Code:

NCT06515925

Conditions

Chronic Pain

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Our Whole Lives (OWL)

Low Dose Mindfulness Training

Study Details

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?

Conditions

Chronic Pain

Study ID

NCT06515925

Start date

Aug 1, 2024

Status verified date

Mar, 2025

Completion date

Nov 30, 2025

Anticipated

Primary completion date

Sep 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

212 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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).

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.

Interventions

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.

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.

Primary outcome measure

  • Reduced pain impact (based on PROMIS 29) [ Time Frame: up to 24 weeks ]

Central Contacts and Locations

Central contacts

Paula Gardiner

617 806 8735pgardiner@challiance.org

Alexandra Comeau

617-806-8735acomeau@challiance.org

Locations

Cambridge Health Alliance Center for Mindfulness and Compassion

Recruiting

Malden, Massachusetts, United States, 02458

Contacts

Paula Gardiner

pgardiner@challiance.org

Alexandra Comeau

617-806-8735acomeau@challiance.org

More Information

Sponsor

Cambridge Health Alliance

Last update posted

Mar 13, 2025

Last verified

Mar, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Cambridge Health Alliance on 2025-03-13.