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

Mass General Brigham

Status: Enrolling

Conditions: Chronic Pain; Depression

Treatments: Behavioral: Quiet Focus; Behavioral: Health Enhancement Program

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07118722

2025P001670

K23AT012363 (U.S. NIH Grant/Contract)

Details and patient eligibility

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?

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 50 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Quiet Focus

Experimental group

Treatment:

Behavioral: Quiet Focus

Health Enhancement Program

Active Comparator group

Treatment:

Behavioral: Health Enhancement Program