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

NCT07118722 | Recruiting DMC

• 2 other identifiers: 2025P001670K23AT012363
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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?

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

  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

• 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

• 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

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 Depression

  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 Emotional Support

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

Study Arms (2)

Quiet Focus

EXPERIMENTAL

Behavioral: Quiet Focus

Health Enhancement Program

ACTIVE COMPARATOR

Behavioral: Health Enhancement Program

Interventions

Quiet Focus BEHAVIORAL

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

Quiet Focus

Health Enhancement Program BEHAVIORAL

Time- and dose-matched control for Quiet Focus.

Health Enhancement Program

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

RECRUITING

MeSH Terms

Conditions

Chronic Pain; Depression

Condition Hierarchy (Ancestors)

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

Study Officials

• Tony V Pham

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tony V Pham

CONTACT

617-800-9988; tonyvpham@mgh.harvard.edu

Tony V Pham

CONTACT

Study Design

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

Study Record Dates

• First Submitted: July 31, 2025
• First Posted: August 12, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: October 2, 2025

Record last verified: 2025-09

Data Sharing

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

Locations

US (1)