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

NCT07336342 | Completed Results

• 2 other identifiers: 2024P001995K23AT012363
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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?

Conditions

Chronic Pain; Depression

Keywords

mindfulness-based cognitive therapy; mind-body; chronic pain; depression; older adult

Outcome Measures

Primary Outcomes (3)

• 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).

• 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.

• 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 Outcomes (11)

• Numerical Rating Scale

  From enrollment to 3 months from the end of treatment at 8 weeks.

• PROMIS Physical Function

  From enrollment to 3 months from the end of treatment at 8 weeks

• PROMIS Anxiety

  From enrollment to 3 months from the end of treatment at 8 weeks

• PROMIS Depression

  From enrollment to 3 months from the end of treatment at 8 weeks

• PROMIS Emotional Support

  From enrollment to 3 months from the end of treatment at 8 weeks.

Study Arms (1)

Mindfulness-based cognitive therapy

EXPERIMENTAL

Behavioral: Mindfulness-based cognitive therapy

Interventions

Mindfulness-based cognitive therapy BEHAVIORAL

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.

Mindfulness-based cognitive therapy

Eligibility Criteria

• Age: 50 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Older adult (age ≥ 50)
• All individuals who identify with one or more nationalities or ethnic groups originating in any of the Black racial groups of Africa
• Pain in muscles, joints, bones, or associated soft tissues (NRS\>4) lasting longer than 3 months
• Depressed (PHQ-9 score of 5-14)
• English fluency/literacy
• Ability and willingness to participate via in-person and video
• No change to type or dose of antidepressant medications for at least 6 weeks prior to screening
• Willing to provide informed consent and comply with all aspects of the protocol

You may not qualify if:

• Moderately severe or severe depressive symptoms (PHQ-9 ≥ 15)
• Current substance abuse/dependence
• Significant cognitive impairment
• History of more than 8 sessions of cognitive-behavioral therapy
• History of previous training in mindfulness or undergoing counseling more than once a month
• History of or current diagnosis of psychosis
• Active suicidal ideation (PHQ-9 item #9 or otherwise reported during screening) or self-harm within the past 90 days
• Current participation in another behavioral clinical trial

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Chronic Pain; Depression

Interventions

Mindfulness-Based Cognitive Therapy

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Tony V Pham
• Organization: Massachusetts General Hospital/Harvard Medical School

tvpham0@mgb.org

6177260469

Study Officials

• Tony V Pham, MD, MScGH

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator and Psychiatrist

Study Record Dates

• First Submitted: January 8, 2026
• First Posted: January 13, 2026
• Study Start: November 15, 2024
• Primary Completion: July 22, 2025
• Study Completion: July 22, 2025
• Last Updated: August 19, 2026
• Results First Posted: August 19, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

US (1)