Actively Recruiting

Phase Not Applicable
Age: 50Years - 120Years
All Genders
NCT07118722

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

Led by Massachusetts General Hospital · Updated on 2025-10-02

60

Participants Needed

1

Research Sites

95 weeks

Total Duration

On this page

Sponsors

M

Massachusetts General Hospital

Lead Sponsor

N

National Center for Complementary and Integrative Health (NCCIH)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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?

CONDITIONS

Official Title

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

Who Can Participate

Age: 50Years - 120Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Older adult aged 50 years or older
  • Identify with one or more Black racial groups of Africa
  • Have muscle, joint, bone, or soft tissue pain lasting more than 3 months with severity over 4 on the NRS
  • Mild to moderate depression with PHQ-9 score between 5 and 14
  • Fluent and literate in English
  • Able and willing to participate in-person and via video
  • No changes in antidepressant medication type or dose for at least 6 weeks before screening
  • Willing to provide informed consent and follow the study protocol
Not Eligible

You will not qualify if you...

  • Severe depressive symptoms with PHQ-9 score of 15 or higher
  • Current substance abuse or dependence
  • Significant cognitive impairment
  • More than 8 previous cognitive-behavioral therapy sessions
  • Previous mindfulness training or counseling more than once a month
  • History or current diagnosis of psychosis
  • Active suicidal thoughts or self-harm within the past 90 days
  • Currently participating in another behavioral clinical trial

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Actively Recruiting

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Research Team

T

Tony V Pham

CONTACT

T

Tony V Pham

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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