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NCT07785648
Mindfulness-Based Cognitive Therapy Vs. the Health Enhancement Program for Chronic Pain and Early Cognitive Decline; The Feeling of Being Pilot RCT
Conditions: Chronic Pain, Mild Cognitive Impairment
Sex: All
Ages: 50 Years – 120 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 60
Sponsor: Massachusetts General Hospital
Location: Massachusetts General Hospital Boston Massachusetts
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?
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
Source: ClinicalTrials.gov (NCT07785648). StuddyBuddy aggregates publicly available trial information.