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Behavioral Intervention

Virtual Integrative Group Visits for Chronic Pain

N/A

Recruiting

Led By Paula Gardiner, MD, MPH

Research Sponsored by Cambridge Health Alliance

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

English-speaking adults

Be older than 18 years old

Must not have

Current mania or psychosis

Severe depression

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 weeks

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to see if a non-prescription web-based program can help people with chronic pain manage their pain better. Researchers want to find out if using this program along with an online group visit can

Who is the study for?

This trial is for individuals experiencing chronic pain. Participants should be comfortable using web-based platforms and engaging in online group sessions. Specific eligibility criteria are not provided, but typically participants must meet certain health conditions to join.

What is being tested?

The study tests a non-prescription, web-based program called Our Whole Lives (OWL) combined with Low Dose Mindfulness Training against a control group to see if it improves self-management of chronic pain and its impact on daily life.

What are the potential side effects?

Since the interventions involve non-medical treatments like mindfulness training and use of a web platform, side effects may be minimal or psychological such as increased anxiety or frustration if the technology is challenging to use.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am an adult who speaks English.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not experiencing mania or psychosis.

Select...

I have been diagnosed with severe depression.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Reduced pain impact (based on PROMIS 29)

Secondary study objectives

Pain Self- Efficacy Scale (PSEQ)

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

Timeline Follow-Back (TLFB)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Our Whole Lives (OWL)Experimental Treatment1 Intervention

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).

Group II: Low Dose Mindfulness TrainingActive Control1 Intervention

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.

0 / 3Eligibility criteria met