Our Whole Lives Gemini: Virtual Integrative Medical Group Visits for Managing Chronic Pain
ConditionChronic Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCambridge Health Alliance
About this trial
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?
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
Our Whole Lives (OWL)
BehavioralOWL 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
BehavioralThe 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.
Treatment groups
212 Participants
are divided into 2 treatment groupsGroup A: Our Whole Lives (OWL)Experimental treatment 1 intervention
Group B: Low Dose Mindfulness TrainingActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Reduced pain impact (based on PROMIS 29)
The primary trial aim is to reduce pain impact.
Time frame
up to 24 weeksSecondary outcomes
1
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.
Time frame
up to 24 weeks2
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.
Time frame
up to 24 weeks3
Timeline Follow-Back (TLFB)
Use of pain meds in the previous 7 days, including opioid use.
Time frame
up to 24 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Cambridge Health Alliance
Lead sponsor
National Center for Complementary and Integrative Health (NCCIH)
Collaborator
BrightOutcome
Collaborator
Source ClinicalTrials.gov