Chronic Pain
Conditions
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?
Detailed description
This study has 6 mandatory components and 1 optional component: * Recruitment Screening Call * Informed Consent Session * Baseline Survey Session * Intervention: Engagement with the Our Whole Lives (OWL) an e-health platform: For 9 weeks, participants will all have access to a mindfulness program within OWL, optimized for people with chronic pain. * Live-Online Mindfulness Group weekly * Control: Low dose engagement with OWL with no group engagement. * Follow-Up Survey Sessions at Week 10, Week 16, and Week 24. * Online Focus Group/Individual Interview. Participants will be asked to participate in an OPTIONAL individual interview, or a one-hour focus group with other participants in the study who used the OWL website as well. 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.
Interventions
BEHAVIORALOur Whole Lives (OWL)
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.
BEHAVIORALLow Dose Mindfulness Training
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.
Sponsors
National Center for Complementary and Integrative Health (NCCIH)
BrightOutcome
Cambridge Health Alliance
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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)
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduced pain impact (based on PROMIS 29) | up to 24 weeks | The primary trial aim is to reduce pain impact. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Patient-Reported Outcomes Measurement Information System (PROMIS 29) | 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. |
| Pain Self- Efficacy Scale (PSEQ) | 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. |
| Timeline Follow-Back (TLFB) | up to 24 weeks | Use of pain meds in the previous 7 days, including opioid use. |
Countries
United States
Contacts
Primary ContactPaula Gardiner
Backup ContactAlexandra Comeau
Outcome results
None listed