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

NCT06515925 | Recruiting DMC

• 2 other identifiers: CHA-IRB-23-24-2601R44AT012302-01A1
• Study Type: interventional
• Target: 212
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Reduced pain impact (based on PROMIS 29)

  The primary trial aim is to reduce pain impact.

  up to 24 weeks

Secondary Outcomes (3)

• The Patient-Reported Outcomes Measurement Information System (PROMIS 29)

  up to 24 weeks

• Pain Self- Efficacy Scale (PSEQ)

  up to 24 weeks

• Timeline Follow-Back (TLFB)

  up to 24 weeks

Study Arms (2)

Our Whole Lives (OWL)

EXPERIMENTAL

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).

Behavioral: Our Whole Lives (OWL)

Low Dose Mindfulness Training

ACTIVE COMPARATOR

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.

Behavioral: Low Dose Mindfulness Training

Interventions

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.

Our Whole Lives (OWL)

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.

Also known as: Low dose comparator

Low Dose Mindfulness Training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Cambridge Health Alliance: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator
• BrightOutcome: collaborator

Study Sites (1)

Cambridge Health Alliance Center for Mindfulness and Compassion

Malden, Massachusetts, 02458, United States

RECRUITING

Related Publications (5)

• Deyo RA, Dworkin SF, Amtmann D, Andersson G, Borenstein D, Carragee E, Carrino J, Chou R, Cook K, DeLitto A, Goertz C, Khalsa P, Loeser J, Mackey S, Panagis J, Rainville J, Tosteson T, Turk D, Von Korff M, Weiner DK. Report of the NIH Task Force on research standards for chronic low back pain. J Pain. 2014 Jun;15(6):569-85. doi: 10.1016/j.jpain.2014.03.005. Epub 2014 Apr 29.

  PMID: 24787228 BACKGROUND

• 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.

  PMID: 26814279 BACKGROUND

• Nicholas MK. The pain self-efficacy questionnaire: Taking pain into account. Eur J Pain. 2007 Feb;11(2):153-63. doi: 10.1016/j.ejpain.2005.12.008. Epub 2006 Jan 30.

  PMID: 16446108 BACKGROUND

• Sobell LC, Sobell MB. Timeline follow-back. Measuring alcohol consumption. Springer;1992:41-72.

  BACKGROUND

• 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.

  PMID: 10710848 BACKGROUND

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Zev Schuman-Olivier, MD

  Cambridge Health Alliance

  STUDY DIRECTOR

• Paula Gardiner, MD, MPH

  Cambridge Health Alliance

  PRINCIPAL INVESTIGATOR

• Niina Haas, PHD

  BrightOutcome

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paula Gardiner

CONTACT

617 806 8735; pgardiner@challiance.org

Alexandra Comeau

CONTACT

617-806-8735; acomeau@challiance.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2024
• First Posted: July 23, 2024
• Study Start: August 1, 2024
• Primary Completion: September 1, 2025
• Study Completion: November 30, 2025
• Last Updated: March 13, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)