RecruitingNot ApplicableNCT07118722

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

Mindfulness-Based Cognitive Therapy Adapted for Older Adults At-Risk for the Chronic Pain-Depression Co-Morbidity; The Quiet Focus Pilot Randomized Controlled Trial


Sponsor

Massachusetts General Hospital

Enrollment

60 participants

Start Date

Sep 1, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 50 YearsMax Age: 120 Years

Inclusion Criteria8

  • Older adult (age ≥ 50)
  • All individuals who identify with one or more nationalities or ethnic groups originating in any of the Black racial groups of Africa
  • Pain in muscles, joints, bones, or associated soft tissues (NRS\>4) lasting longer than 3 months
  • Depressed (PHQ-9 score of 5-14)
  • English fluency/literacy
  • Ability and willingness to participate via in-person and video
  • No change to type or dose of antidepressant medications for at least 6 weeks prior to screening
  • Willing to provide informed consent and comply with all aspects of the protocol

Exclusion Criteria8

  • Moderately severe or severe depressive symptoms (PHQ-9 ≥ 15)
  • Current substance abuse/dependence
  • Significant cognitive impairment
  • History of more than 8 sessions of cognitive-behavioral therapy
  • History of previous training in mindfulness or undergoing counseling more than once a month
  • History of or current diagnosis of psychosis
  • Active suicidal ideation (PHQ-9 item #9 or otherwise reported during screening) or self-harm within the past 90 days
  • Current participation in another behavioral clinical trial

Interventions

BEHAVIORALQuiet Focus

Mindfulness-based cognitive therapy adapted for older adults at-risk for chronic pain and depression

BEHAVIORALHealth Enhancement Program

Time- and dose-matched control for Quiet Focus.


Locations(1)

Massachusetts General Hospital

Boston, Massachusetts, United States

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NCT07118722


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