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: Mindfulness-based cognitive therapy

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: Mindfulness-based cognitive therapy

Behavioral: Mindfulness-based cognitive therapy; The delivered intervention is mindfulness-based cognitive therapy adapted for the chronic pain and depression among older Black adults. Mindfulness-based cognitive therapy (MBCT) is a structured psychotherapy that integrates mindfulness practices with cognitive behavioral therapy techniques. This adapted MBCT is delivered as an 8-week group-based program with each weekly session lasting about 1 hour. Sessions occur once per week, supplemented by daily home practice of 40-60 minutes, 6 days a week, involving guided meditations, body scans, and mindful activities to reinforce skills.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Client Satisfaction Questionnaire	The 3-item version of the Client Satisfaction Questionnaire (CSQ-3) is scored by summing responses from its three core items. It consists of empirically selected items measuring key aspects of service satisfaction, each rated on a 4-point Likert scale (1 = lowest satisfaction to 4 = highest, with directionality adjusted as needed). Total scores range from 3 to 12, with higher values indicating greater satisfaction; no reverse scoring or subscales are required.	Administered at the end of treatment at 8 weeks.
The Credibility and Expectancy Questionnaire	The Credibility/Expectancy Questionnaire (CEQ) is a 6-item self-report measure assessing treatment credibility (items 1-3) and expectancy (items 4-6). Items 1-3 and 5 are rated 0 (not at all credible/logical) to 9 (extremely credible/logical), while items 4 and 6 are rated 0% to 100%; subscale scores are standardized and summed (credibility: 3-27 raw equivalent; expectancy similar), with total scores ranging 6-54 after standardization, where higher scores indicate greater credibility and positive outcome expectancy (better outcome).	Baseline (at enrollment, prior to intervention initiation).
Modified Patient Global Impression of Change	The Modified Patient Global Impression of Change (mPGIC) adapts the standard single-item Patient Global Impression of Change (PGIC), a validated patient-reported outcome measure of overall perceived change since intervention, by assessing change across six specific domains. Each domain uses a single ordinal item rated on a 7-point scale, coded from 1 = Very Much Improved to 7 = Very Much Worse. Lower scores indicate greater perceived improvement. Domains include coping strategies, physical activity, social activity, level of stress, memory and thinking, and pain, and are analyzed separately.	At end of 8 week program (post test) and again at 3 month follow up visit.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numerical Rating Scale	The Numerical Rating Scale (NRS) for pain intensity is an 11-point scale from 0 (no pain) to 10 (worst imaginable pain), assessing average pain over the past week. Higher scores indicate greater pain intensity (worse outcome), lower scores less pain (better); single-item total score.	From enrollment to 3 months from the end of treatment at 8 weeks.
PROMIS Anxiety	The PROMIS Short Form V1.0 - Emotional Distress Anxiety 8a (PROMIS Anxiety SF 8a v1.0) is an 8-item patient-reported outcome measure assessing self-reported anxiety symptoms over the past 7 days, including fear, nervousness, worry, dread, and feeling tense or restless. It uses a 5-point Likert response scale per item: Never (1), Rarely (2), Sometimes (3), Often (4), or Always (5). Raw total scores range from 8 (minimal anxiety, best outcome) to 40 (severe anxiety, worst outcome); these convert via scoring tables to T-scores (mean=50, SD=10 in U.S. population), where higher T-scores indicate greater anxiety severity. No subscales are computed; the total score reflects overall anxiety distress. T-score range: 28-82 for the 8a short form.	From enrollment to 3 months from the end of treatment at 8 weeks
PROMIS Physical Function	The PROMIS Short Form V2.0 - Physical Function 8B (PROMIS PF 8B v2.0) is an 8-item patient-reported outcome measure assessing self-reported capability in physical activities, including upper extremity function (e.g., hand/arm tasks), lower extremity function (e.g., walking), central body function, and daily activities. It uses a 5-point Likert response scale per item: Without any difficulty (5), With little difficulty (4), With some difficulty (3), With much difficulty (2), or Unable to do/Cannot do (1). Raw total scores range from 8 (severe difficulty, worst outcome) to 40 (no difficulty, best outcome); these convert via scoring tables to T-scores (mean=50, SD=10 in U.S. population), where higher T-scores indicate better physical function. No subscales are computed; the total score reflects overall physical function. The T-score range for the PROMIS SF V1.2 is 10-65.	From enrollment to 3 months from the end of treatment at 8 weeks
PROMIS Depression	The PROMIS Short Form V1.0 - Emotional Distress Depression 8b (PROMIS Depression SF 8b v1.0) is an 8-item patient-reported outcome measure assessing self-reported depressive symptoms over the past 7 days, including feelings of worthlessness, helplessness, sadness, failure, depression, unhappiness, and hopelessness. It uses a 5-point Likert response scale per item: Never (1), Rarely (2), Sometimes (3), Often (4), or Always (5). Raw total scores range from 8 (minimal depression, best outcome) to 40 (severe depression, worst outcome); these convert via scoring tables to T-scores (mean=50, SD=10 in U.S. population), where higher T-scores indicate greater depression severity. No subscales are computed; the total score reflects overall depressive distress. T-score range: 42-84.	From enrollment to 3 months from the end of treatment at 8 weeks
PROMIS Emotional Support	The PROMIS Short Form V2.0 - Emotional Support 8a (PROMIS Emotional Support SF 8a v2.0) is an 8-item patient-reported outcome measure assessing perceived availability of supportive interpersonal relationships over the past 7 days, including listening, confiding, appreciation, understanding, and trust. It uses a 5-point Likert response scale per item: Never (1), Rarely (2), Sometimes (3), Often (4), or Always (5). Raw total scores range from 8 (minimal support, worst outcome) to 40 (strong support, best outcome); these convert via scoring tables to T-scores (mean=50, SD=10 in U.S. population), where higher T-scores indicate greater emotional support. No subscales are computed; the total score reflects overall perceived support. T-score range: 25-75 for the 8a short form.	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 Measure of Current Status Part A (MOCS-A) comprises 13 items rated 0 (cannot do at all) to 4 (extremely well), summed for total score 0-52, with four subscales: relaxation, tension awareness, assertiveness, coping confidence (higher total/subscale scores indicate better stress management ability, better outcome). Each item is 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.	From enrollment to 3 months from the end of treatment at 8 weeks
Cognitive and Affective Mindfulness Scale-Revised	The Cognitive and Affective Mindfulness Scale-Revised (CAMS-R) is a 12-item scale rated 1 (rarely/not at all) to 4 (almost always), total score summed 12-48 (higher scores indicate greater mindfulness ability, better outcome); unidimensional total score. Scoring: Items 2, 6, and 7 are reverse-scored. After appropriate reversals, sum values for items 1-12. Higher values reflect greater mindful qualities.	From enrollment to 3 months from the end of treatment at 8 weeks
Chronic Pain Acceptance Questionnaire	The Chronic Pain Acceptance Questionnaire (CPAQ) sums 20 items rated 0 (never true) to 6 (always true) for total raw score 0-120, with two subscales: Activity Engagement (0-66) and Pain Willingness (0-54), both/totals higher indicating greater pain acceptance (better outcome).	From enrollment to 3 months from the end of treatment at 8 weeks
Pain Self-Efficacy Questionnaire	The Pain Self-Efficacy Questionnaire (PSEQ) consists of 10 items rated 0 (not at all confident) to 6 (completely confident), summed for total 0-60. Higher scores indicate greater self-efficacy despite pain (better outcome); single total score.	From enrollment to 3 months from the end of treatment at 8 weeks
Pain Catastrophizing Scale	The Pain Catastrophizing Scale (PCS) sums 13 items rated 0 (not at all) to 4 (all the time) for total 0-52, with subscales: Rumination (0-16), Magnification (0-12), Helplessness (0-24); higher scores indicate greater catastrophizing (worse outcome).	From enrollment to 3 months from the end of treatment at 8 weeks
Tampa Kinesiophobia Scale	The Tampa Scale of Kinesiophobia (TSK-17) sums 17 items rated 1 (strongly disagree) to 4 (strongly agree), with reverse on items 4, 8, 12, and 16. Total score range: 17-68 (higher scores greater kinesiophobia/fear of movement, worse outcome).	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): August 19, 2026
• Last Update Submitted That Met QC Criteria: August 16, 2026
• Last Verified: August 1, 2026

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; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Cognitive Behavioral Therapy; Mindfulness; Mindfulness-Based Cognitive Therapy
• 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