RECRUITING Not applicable ClinicalTrials.gov

Mindfulness-based Cognitive Therapy vs the Health Enhancement Program for Chronic Pain and Depression; The Quiet Focus Study

Sponsor: Massachusetts General Hospital • ClinicalTrials.gov ID: NCT07118722

Registry updated: 2026-08-25

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Description

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?

Interventions

Quiet Focus (Behavioral)
Mindfulness-based cognitive therapy adapted for older adults at-risk for chronic pain and depression
Health Enhancement Program (Behavioral)
Time- and dose-matched control for Quiet Focus.

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

Conditions

Chronic Pain Depression

Locations

Massachusetts General Hospital — Boston, Massachusetts, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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