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

NCT ID: NCT07118722

Last Updated: 2025-10-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2027-06-30

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?

Detailed Description

Co-morbid chronic pain-depression is common among older Black adults and this co-morbidity worsens physical and emotional function. Access to evidence based non-pharmacological management is limited. Mindfulness based cognitive therapy (MBCT) is an evidence-based, non-pharmacological intervention that could address the chronic pain-depression co-morbidity among older Black adults, but it requires tailoring. The proposed study will establish the feasibility, acceptability and credibility of Quiet Focus, a cultural adaptation of MBCT aimed at the chronic pain-depression co-morbidity among older Black adults in the community.

Conditions

Chronic Pain; Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Quiet Focus

Group Type: EXPERIMENTAL

Quiet Focus

Intervention Type: BEHAVIORAL

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

Health Enhancement Program

Group Type: ACTIVE_COMPARATOR

Health Enhancement Program

Intervention Type: BEHAVIORAL

Time- and dose-matched control for Quiet Focus.

Interventions

Quiet Focus

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

Intervention Type: BEHAVIORAL

Health Enhancement Program

Time- and dose-matched control for Quiet Focus.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Tony V. Pham, MD

Principal Investigator and Psychiatrist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tony V Pham

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Tony V Pham

Role: CONTACT

tonyvpham@mgh.harvard.edu

617-800-9988

Tony V Pham

Role: CONTACT

Facility Contacts

Kelly Horan

Role: primary

khoran@mgb.org

617-726-2000

Other Identifiers

K23AT012363

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2025P001670

Identifier Type: -

Identifier Source: org_study_id