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?
Co-morbid chronic pain-depression is common among older Black adults and this co-morbidity worsens physical and emotional 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-depression co-morbidity among older Black adults, but it requires tailoring. The proposed study will establish the feasibility, acceptability and credibility of Quiet Focus, a cultural adaptation of MBCT aimed at the chronic pain-depression co-morbidity among older Black adults in the community.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
60
Mindfulness-based cognitive therapy adapted for older adults at-risk for chronic pain and depression
Time- and dose-matched control for Quiet Focus.
Massachusetts General Hospital
Boston, Massachusetts, United States
RECRUITINGThe 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.
Time frame: From enrollment to 3 months from the end of treatment at 8 weeks
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).
Time frame: Administered at the end of treatment at 8 weeks and at the three month follow up visit
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.
Time frame: At end of 8 week program (post test) and again at 3 month follow up visit
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.
Time frame: From enrollment to 3 months from the end of treatment at 8 weeks
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.
Time frame: From enrollment to 3 months from the end of treatment at 8 weeks
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.
Time frame: From enrollment to 3 months from the end of treatment at 8 weeks
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.
Time frame: From enrollment to 3 months from the end of treatment at 8 weeks
PROMIS Emotional Support
The PROMIS Emotional Support 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 greater perceived emotional support. This raw score is converted to a T-score using a standardized table, where 50 represents the average for the general population and 10 is the standard deviation.
Time frame: From enrollment to 3 months from the end of treatment at 8 weeks
Measure of Current Status Part A
The Measure of Current Status Part A (MOCS-A) is a self-report questionnaire that measures ability to manage stress. The score is calculated by summing responses to each item, rated on a 5-point Likert scale where 0 = "I cannot do this at all" and 4 = "I can do this extremely well," with higher scores reflecting greater confidence in coping skills. The scale measures current perceived ability to manage stress across areas like relaxation, awareness of tension, assertiveness, and coping confidence.
Time frame: From enrollment to 3 months from the end of treatment at 8 weeks
Cognitive and Affective Mindfulness Scale-Revised
The Cognitive and Affective Mindfulness Scale - Revised (CAMS-R) measures percieved ability to complete mindfulness tasks such as meditation, with a 0 being rarely/not at all and a 3 being almost always. Higher scores indicate greater ability to practice mindfulness skills.
Time frame: From enrollment to 3 months from the end of treatment at 8 weeks
Chronic Pain Acceptance Questionnaire
The Chronic Pain Acceptance Questionnaire (CPAQ)\*= raw score is calculated by summing responses to each item, rated on a 7-point Likert scale where 0 = "Never true" and 6 = "Always true," with higher scores indicating greater acceptance of chronic pain. The scale assesses two key areas: pain willingness(the ability to experience pain without trying to control or avoid it) and activity engagement (continuing meaningful activities despite pain).
Time frame: From enrollment to 3 months from the end of treatment at 8 weeks
Pain Self-Efficacy Questionnaire
The Pain Self-Efficacy Questionnaire (PSEQ) measures confidence in engaging in activities despite chronic pain. Higher scores indicate greater confidence (6 = complete confidence) and lower scores indicate lower confidence (0 = not at all confident).
Time frame: From enrollment to 3 months from the end of treatment at 8 weeks
Pain Catastrophizing Scale
The Pain Catastrophizing Scale (PCS) score is calculated by summing responses to each item, rated on a 5-point Likert scale where 0 = "Not at all" and 4 = "All the time," with higher scores indicating greater levels of catastrophic thinking related to pain. The scale measures three components of pain catastrophizing: rumination, magnification, and helplessness.
Time frame: From enrollment to 3 months from the end of treatment at 8 weeks
Tampa Kinesiophobia Scale
The Tampa Kinesiophobia Scale (TKS) measures fear of movement and is calculated by summing responses to each item, rated on a 4-point Likert scale where 1 = "Strongly disagree" and 4 = "Strongly agree," with higher scores indicating greater fear of movement or reinjury due to physical activity.
Time frame: From enrollment to 3 months from the end of treatment at 8 weeks
Tony V Pham
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