NCT07118722 Mindfulness-based Cognitive Therapy vs the Health Enhancement Program for Chronic Pain and Depression; The Quiet Focus Study
| NCT ID | NCT07118722 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Massachusetts General Hospital |
| Condition | Chronic Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-09-01 |
| Primary Completion | 2026-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2025-09-01 with a primary completion date of 2026-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to pilot a randomized controlled trial comparing an adaptation of mindfulness-based cognitive therapy to the health enhancement program for chronic pain and depression. The main questions it aims to answer in a later fully powered randomized controlled trial are: * Is an adaptation of mindfulness-based cognitive therapy for older Black adults able to improve quality of life? * Will an adapted mindfulness based cognitive therapy reduce pain interference to a greater degree than a traditional health enhancement program?
Eligibility 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
Contact & Investigator
Tony V Pham
PRINCIPAL INVESTIGATOR
Massachusetts General Hospital
Frequently Asked Questions
Who can join the NCT07118722 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, up to 120 Years, studying Chronic Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07118722 currently recruiting?
Yes, NCT07118722 is actively recruiting participants. Contact the research team at tonyvpham@mgh.harvard.edu for enrollment information.
Where is the NCT07118722 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT07118722 clinical trial?
NCT07118722 is sponsored by Massachusetts General Hospital. The principal investigator is Tony V Pham at Massachusetts General Hospital. The trial plans to enroll 60 participants.
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