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| ID | Type | Description | Link |
|---|---|---|---|
| 1R44AT012302-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
| BrightOutcome | INDUSTRY |
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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?
This study has 6 mandatory components and 1 optional component:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Reduced pain impact (based on PROMIS 29) | The primary trial aim is to reduce pain impact. | up to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The Patient-Reported Outcomes Measurement Information System (PROMIS 29) | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Paula Gardiner | Contact | 617 806 8735 | pgardiner@challiance.org | |
| Alexandra Comeau | Contact | 617-806-8735 | acomeau@challiance.org |
| Name | Affiliation | Role |
|---|---|---|
| Zev Schuman-Olivier, MD | Cambridge Health Alliance | Study Director |
| Paula Gardiner, MD, MPH | Cambridge Health Alliance | Principal Investigator |
| Niina Haas, PHD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cambridge Health Alliance Center for Mindfulness and Compassion | Recruiting | Malden | Massachusetts | 02458 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24787228 | Background | 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. | |
| 26814279 | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jul 3, 2024 | Jul 15, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 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. |
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| up to 24 weeks |
| Pain Self- Efficacy Scale (PSEQ) | 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. | up to 24 weeks |
| Timeline Follow-Back (TLFB) | Use of pain meds in the previous 7 days, including opioid use. | up to 24 weeks |
| BrightOutcome |
| Principal Investigator |
| 16446108 | 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. |
| Background | Sobell LC, Sobell MB. Timeline follow-back. Measuring alcohol consumption. Springer;1992:41-72. |
| 10710848 | 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. |