Cambridge Health Alliance Center for Mindfulness and Compassion
Malden, Massachusetts, 02458, United States
Location status: Recruiting
NCT Number: NCT06515925
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?
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Malden, Massachusetts, 02458, United States
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Other names: Low dose comparator
Time frame: up to 24 weeks
The primary trial aim is to reduce pain impact.
Time frame: 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.
Time frame: 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.
Time frame: up to 24 weeks
Use of pain meds in the previous 7 days, including opioid use.
Contact information is provided by the study sponsor or research team.
Alexandra Comeau
CONTACT
Paula Gardiner
CONTACT
Cambridge Health Alliance
Other
Phase II: GEMINI: Virtual Integrative Medical Group Visits for Managing Chronic Pain
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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