Mindfulness-based Cognitive Therapy for the Chronic Pain-early Cognitive Decline Co-morbidity Among Older Black Individuals in the Community; The Feeling of Being Open Pilot

NCT ID: NCT07210398

Last Updated: 2025-10-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-05
• Study Completion Date: 2025-07-22

Brief Summary

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

Detailed Description

Co-morbid chronic pain and early cognitive decline is common among older Black adults and this co-morbidity worsens physical and cognitive 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 and early cognitive decline co-morbidity among older Black adults, but it requires tailoring. The proposed study will establish the feasibility, acceptability and credibility of Feeling of Being, a cultural adaptation of MBCT aimed at the chronic pain and early cognitive decline co-morbidity among older Black adults in the community.

Conditions

Chronic Pain; Early Cognitive Decline

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Feeling of Being

Group Type: EXPERIMENTAL

Quiet Focus

Intervention Type: BEHAVIORAL

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

Interventions

Quiet Focus

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Center for Advancing Translational Sciences (NCATS)

NIH

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Tony V. Pham, MD

Principal Investigator and Psychiatrist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tony V Pham

Role: PRINCIPAL_INVESTIGATOR

MGH

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

UM1TR004408

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2024P002081

Identifier Type: -

Identifier Source: org_study_id