Mindfulness-based Cognitive Therapy for the Chronic Pain-depression Co-morbidity Among Older Black Adults in the Community; The Quiet Focus Open Pilot

The goal of this clinical trial is to pilot an adaptation of mindfulness-based cognitive therapy 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?

Study Overview

• Status: Completed
• Conditions: Depression; Chronic Pain
• Intervention / Treatment: Behavioral: Quiet Focus

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Quiet Focus	Behavioral: Quiet Focus; Mindfulness-based cognitive therapy adapted for older adults at-risk for chronic pain and depression.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Credibility and Expectancy Questionnaire	This scale measures participant expectations around the study's positive outcomes, with measures ranging from 0 (not at all expected) to 9 (extremely expected). A higher score indicate greater trust in the study design and an openness to potential benefits.	From enrollment to 3 months from the end of treatment at 8 weeks
Modified Patient Global Impression of Change	Measures participant impressions of overall change with one being very much improved and eight being very much worse. Lower scores indicate improvement.	At end of 8 week program (post test) and again at 3 month follow up visit.
The Client Satisfaction Questionnaire	Three item scale measuring patient satisfaction with the program. Scores for each item range from 1 (unsatisfied) to 4 (very satisfied).	Administered at the end of treatment at 8 weeks and at the three month follow up visit.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PROMIS Depression	The PROMIS Depression raw score is calculated by summing item responses, each rated on a 5-point Likert scale where 1 = "Never" and 5 = "Always," with higher scores indicating more severe depressive symptoms. This raw score is converted to a T-score using a standardized table, where 50 represents the average level in the general population and 10 is the standard deviation.	From enrollment to 3 months from the end of treatment at 8 weeks
PROMIS Anxiety	The PROMIS Anxiety raw score is calculated by summing item responses, each rated on a 5-point Likert scale where 1 = "Never" and 5 = "Always," with higher scores reflecting greater anxiety symptoms. The raw score is then converted to a T-score using a standardized scoring table, with 50 representing the population average and 10 as the standard deviation.	From enrollment to 3 months from the end of treatment at 8 weeks
Measure of Current Status Part A	The Measure of Current Status Part A (MOCS-A) is a self-report questionnaire that measures ability to manage stress. The score is calculated by summing responses to each item, rated on a 5-point Likert scale where 0 = "I cannot do this at all" and 4 = "I can do this extremely well," with higher scores reflecting greater confidence in coping skills. The scale measures current perceived ability to manage stress across areas like relaxation, awareness of tension, assertiveness, and coping confidence.	From enrollment to 3 months from the end of treatment at 8 weeks
Chronic Pain Acceptance Questionnaire	The Chronic Pain Acceptance Questionnaire (CPAQ)*= raw score is calculated by summing responses to each item, rated on a 7-point Likert scale where 0 = "Never true" and 6 = "Always true," with higher scores indicating greater acceptance of chronic pain. The scale assesses two key areas: pain willingness(the ability to experience pain without trying to control or avoid it) and activity engagement (continuing meaningful activities despite pain).	From enrollment to 3 months from the end of treatment at 8 weeks
Pain Self-Efficacy Questionnaire	The Pain Self-Efficacy Questionnaire (PSEQ) measures confidence in engaging in activities despite chronic pain. Higher scores indicate greater confidence (6 = complete confidence) and lower scores indicate lower confidence (0 = not at all confident).	From enrollment to 3 months from the end of treatment at 8 weeks
Pain Catastrophizing Scale	The Pain Catastrophizing Scale (PCS) score is calculated by summing responses to each item, rated on a 5-point Likert scale where 0 = "Not at all" and 4 = "All the time," with higher scores indicating greater levels of catastrophic thinking related to pain. The scale measures three components of pain catastrophizing: rumination, magnification, and helplessness.	From enrollment to 3 months from the end of treatment at 8 weeks
Tampa Kinesiophobia Scale	The Tampa Kinesiophobia Scale (TKS) measures fear of movement and is calculated by summing responses to each item, rated on a 4-point Likert scale where 1 = "Strongly disagree" and 4 = "Strongly agree," with higher scores indicating greater fear of movement or reinjury due to physical activity.	From enrollment to 3 months from the end of treatment at 8 weeks
Numerical Rating Scale	Numerical rating of pain with lower scores indicating less pain overall (0 = no pain) and higher scores indicating more pain (10 = worst ever pain) over the past week.	From enrollment to 3 months from the end of treatment at 8 weeks.
PROMIS Physical Function	The PROMIS Depression raw score is calculated by summing item responses, each rated on a 5-point Likert scale where 1 = "Never" and 5 = "Always," with higher scores indicating more severe depressive symptoms. This raw score is converted to a T-score using a standardized table, where 50 represents the average level in the general population and 10 is the standard deviation.	From enrollment to 3 months from the end of treatment at 8 weeks
PROMIS Emotional Support	The PROMIS Emotional Support raw score is calculated by summing item responses, each rated on a 5-point Likert scale where 1 = "Never" and 5 = "Always," with higher scores indicating greater perceived emotional support. This raw score is converted to a T-score using a standardized table, where 50 represents the average for the general population and 10 is the standard deviation.	From enrollment to 3 months from the end of treatment at 8 weeks.
Cognitive and Affective Mindfulness Scale-Revised	Description: The Cognitive and Affective Mindfulness Scale - Revised (CAMS-R) measures percieved ability to complete mindfulness tasks such as meditation, with a 0 being rarely/not at all and a 3 being almost always. Higher scores indicate greater ability to practice mindfulness skills.	From enrollment to 3 months from the end of treatment at 8 weeks

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: National Center for Complementary and Integrative Health (NCCIH)
• Investigators: Principal Investigator: Tony V Pham, MD, MScGH, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2024
• Primary Completion (Actual): July 22, 2025
• Study Completion (Actual): July 22, 2025

Study Registration Dates

• First Submitted: January 8, 2026
• First Submitted That Met QC Criteria: January 10, 2026
• First Posted (Actual): January 13, 2026

Study Record Updates

• Last Update Posted (Actual): January 13, 2026
• Last Update Submitted That Met QC Criteria: January 10, 2026
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: chronic pain; depression; mind-body; older adult; mindfulness-based cognitive therapy
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Behavioral Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Chronic Pain; Depression
• Other Study ID Numbers: 2024P001995; K23AT012363 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All IPD collected throughout the trial.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No