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

Mass General Brigham

Status: Completed

Conditions: Early Cognitive Decline; Chronic Pain

Treatments: Behavioral: Quiet Focus

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07210398

2024P002081

UM1TR004408 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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?

Full 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.

Enrollment: 9 patients

Sex: All

Ages: 50 to 120 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 1 patient group

Feeling of Being

Experimental group

Treatment:

Behavioral: Quiet Focus