Mindfulness-based Cognitive Therapy versus a Health Enhancement Program for chronic pain and depression in older Black adults
Mindfulness-Based Cognitive Therapy Adapted for Older Adults At-Risk for the Chronic Pain-Depression Co-Morbidity; The Quiet Focus Pilot Randomized Controlled Trial
NA · Massachusetts General Hospital · NCT07118722
This pilot will see if Quiet Focus, a culturally adapted mindfulness-based cognitive therapy program, helps older Black adults with long-term pain and mild-to-moderate depression more than a general health program.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 50 Years to 120 Years |
| Sex | All |
| Sponsor | Massachusetts General Hospital (other) |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT07118722 on ClinicalTrials.gov |
What this trial studies
This randomized pilot compares Quiet Focus, an adaptation of mindfulness-based cognitive therapy (MBCT) tailored for older Black adults, to a Health Enhancement Program (a structurally matched active control). The trial enrolls community-dwelling adults age 50 and older with chronic musculoskeletal pain and mild-to-moderate depressive symptoms and uses in-person and video-delivered sessions. Primary aims are to establish feasibility, acceptability, and credibility of the adapted MBCT and to collect preliminary data on pain interference and quality of life outcomes. Findings will be used to design a later fully powered randomized controlled trial.
Who should consider this trial
Good fit: Ideal candidates are English-fluent adults age 50 or older who identify with Black racial/ethnic groups, have chronic musculoskeletal pain (NRS >4 for >3 months) and mild-to-moderate depressive symptoms (PHQ-9 score 5–14), and can attend in-person or video sessions without recent changes in antidepressant dosing.
Not a fit: Patients with moderately severe or severe depression (PHQ-9 ≥15), current substance dependence, significant cognitive impairment, active psychosis, extensive prior CBT or mindfulness training, or inability to participate in person or by video are unlikely to benefit from this pilot.
Why it matters
Potential benefit: If successful, Quiet Focus could improve quality of life and reduce pain-related interference and depressive symptoms in older Black adults using a culturally tailored, non-drug approach.
How similar studies have performed: MBCT has demonstrated benefit for depressive symptoms and some chronic pain outcomes in prior trials, but culturally adapted MBCT specifically for older Black adults is largely novel and not well tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Participant Inclusion Criteria 1. Older adult (age ≥ 50) 2. All individuals who identify with one or more nationalities or ethnic groups originating in any of the Black racial groups of Africa 3. Pain in muscles, joints, bones, or associated soft tissues (NRS\>4) lasting longer than 3 months 4. Depressed (PHQ-9 score of 5-14) 5. English fluency/literacy 6. Ability and willingness to participate via in-person and video 7. No change to type or dose of antidepressant medications for at least 6 weeks prior to screening 8. Willing to provide informed consent and comply with all aspects of the protocol Participant Exclusion Criteria 1. Moderately severe or severe depressive symptoms (PHQ-9 ≥ 15) 2. Current substance abuse/dependence 3. Significant cognitive impairment 4. History of more than 8 sessions of cognitive-behavioral therapy 5. History of previous training in mindfulness or undergoing counseling more than once a month 6. History of or current diagnosis of psychosis 7. Active suicidal ideation (PHQ-9 item #9 or otherwise reported during screening) or self-harm within the past 90 days 8. Current participation in another behavioral clinical trial
Where this trial is running
Boston, Massachusetts
- Massachusetts General Hospital — Boston, Massachusetts, United States (RECRUITING)
Study contacts
- Principal investigator: Tony V Pham — Massachusetts General Hospital
- Study coordinator: Tony V Pham
- Email: tonyvpham@mgh.harvard.edu
- Phone: 617-800-9988
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Chronic Pain, Depression, mindfulness-based cognitive therapy, mind-body, chronic pain, depression, older adult