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?
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
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
Parallel
Quiet Focus
BehavioralMindfulness-based cognitive therapy adapted for older adults at-risk for chronic pain and depression
Health Enhancement Program
BehavioralTime- and dose-matched control for Quiet Focus.
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.
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).
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.
Numerical Rating Scale
Numerical rating of pain with lower scores indicating less pain overall (0 = no pain) and higher scores indicating more pain (10 = worst ever pain) over the past week.
PROMIS Physical Function
The PROMIS Physical Function raw score is calculated by summing item responses, each rated on a 5-point Likert scale where 1 = "Unable to do" and 5 = "Without any difficulty," with higher scores indicating better function. This raw score is then converted to a T-score using a standardized table, where 50 represents the average in the general population and 10 is the standard deviation.
PROMIS Depression
The PROMIS Depression raw score is calculated by summing item responses, each rated on a 5-point Likert scale where 1 = "Never" and 5 = "Always," with higher scores indicating more severe depressive symptoms. This raw score is converted to a T-score using a standardized table, where 50 represents the average level in the general population and 10 is the standard deviation.
PROMIS Anxiety
The PROMIS Anxiety raw score is calculated by summing item responses, each rated on a 5-point Likert scale where 1 = "Never" and 5 = "Always," with higher scores reflecting greater anxiety symptoms. The raw score is then converted to a T-score using a standardized scoring table, with 50 representing the population average and 10 as the standard deviation.
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Massachusetts General Hospital
Lead sponsor
National Center for Complementary and Integrative Health (NCCIH)
Collaborator