Mindfulness-Based Cognitive Therapy Vs. the Health Enhancement Program for Chronic Pain and Early Cognitive Decline; The Feeling of Being Pilot RCT

NCT07785648 | Not Yet Recruiting DMC

• 1 other identifier: 2026P002003
• 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 early cognitive decline. 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; Mild Cognitive Impairment

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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).

  At enrollment

• 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: Very Much Improved (coded 1), Much Improved (2), Minimally Improved (3), No Change (4), Minimally Worse (5), Much Worse (6) or Very Much Worse (7). The range per domain is 0 (worst, Much Worse) to 5 (best, Very Much Improved), with higher scores indicating greater perceived improvement. Domains are analyzed individually as mean scores (no total computed), where values \<4 reflect net positive change. Domains include coping strategies, physical activity, social activity, level of stress, memory and thinking, and pain.

  At end of 8 week program (post test) and again at 3 month follow up visit.

Secondary Outcomes (13)

• 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

  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 ten

• PROMIS Emotional Support

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

• Measure of Current Status Part A

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

Study Arms (2)

Quiet Focus

EXPERIMENTAL

Behavioral: Feeling of Being

Health Enhancement Program

ACTIVE COMPARATOR

Behavioral: Health Enhancement Program

Interventions

Feeling of Being BEHAVIORAL

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

Quiet Focus

Health Enhancement Program BEHAVIORAL

Time- and dose-matched control for Feeling of Being.

Health Enhancement Program

Eligibility Criteria

• Age: 50 Years - 120 Years
• Sex: all
• Healthy Volunteers: Yes
• 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
• Early Cognitive Decline (subjective or MCI)
• Telephone Interview for Cognitive Status-41 score ≥ 26
• Functional Activities Questionnaire score \< 9
• English fluency/literacy
• Ability and willingness to participate via in-person and video
• Willing to provide informed consent and comply with all aspects of the protocol

You may not qualify if:

• 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 or self-harm within the past 90 days

Sponsors & Collaborators

• National Institute on Aging (NIA): collaborator
• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Chronic Pain; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Tony V Pham

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tony V Pham

CONTACT

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

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: August 21, 2026
• First Posted: August 25, 2026
• Study Start (Estimated): October 18, 2026
• Primary Completion (Estimated): November 18, 2027
• Study Completion (Estimated): September 17, 2028
• Last Updated: August 25, 2026

Record last verified: 2026-08

Data Sharing

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

Locations

US (1)