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Search / Trial NCT07118722

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

Launched by MASSACHUSETTS GENERAL HOSPITAL · Aug 7, 2025

Trial Information

Current as of August 19, 2025

Not yet recruiting

Keywords

Mindfulness Based Cognitive Therapy Mind Body Chronic Pain Depression Older Adult

ClinConnect Summary

This clinical trial is studying two different types of programs to help older Black adults who are living with both chronic pain and mild to moderate depression. One program uses a type of mindfulness-based cognitive therapy, which combines mindfulness skills with thinking strategies to improve mental well-being. The other program is a traditional health enhancement program, which focuses on general health activities. The study wants to see if the mindfulness-based therapy can improve quality of life and reduce how much pain interferes with daily activities better than the health enhancement program.

To join the study, participants need to be 50 years or older, identify as Black or of African descent, have ongoing pain in muscles, joints, or bones for more than three months, and have mild to moderate depression (not severe). Participants should be able to understand and speak English and be willing to take part in sessions either in person or online. People with very severe depression, certain mental health conditions, recent substance abuse, or extensive previous therapy experience may not be eligible. Those who join will be randomly assigned to one of the two programs and will take part in regular sessions designed to support their pain and mood. This study is not yet recruiting but aims to find better ways to help older Black adults manage chronic pain and depression in the future.

Gender

ALL

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

About Massachusetts General Hospital

Massachusetts General Hospital (MGH) is a leading academic medical center located in Boston, Massachusetts, renowned for its commitment to advancing medical research and patient care. As a prominent teaching hospital affiliated with Harvard Medical School, MGH plays a pivotal role in clinical trials across a wide range of disciplines, including cardiology, oncology, neurology, and more. The institution is dedicated to fostering innovative research that translates into effective therapies and improved health outcomes. MGH's Clinical Trials Office provides comprehensive support to facilitate the design, implementation, and management of clinical studies, ensuring adherence to the highest ethical standards and regulatory compliance. With a focus on collaboration and patient-centered care, MGH strives to enhance medical knowledge and contribute to the future of healthcare.

Locations

Patients applied

0 patients applied

Trial Officials

Ana-Maria Vranceanu

Principal Investigator

MGH

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported