An interventional study of Feeling of Being and Health Enhancement Program in Chronic Pain and Mild Cognitive Impairment, sponsored by Massachusetts General Hospital. Not yet recruiting at 1 site in United States. Open to participants aged 50 Years to 120 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-25.
Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Other
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:
Co-morbid chronic pain and early cognitive decline 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.
Exclusion Criteria:
Behavioral: Feeling of Being
Behavioral: Health Enhancement Program
Mindfulness-based cognitive therapy adapted for older adults at-risk for chronic pain and early cognitive decline
Time- and dose-matched control for Feeling of Being.
The Client Satisfaction Questionnaire
The 3-item version of the Client Satisfaction Questionnaire (CSQ-3) is scored by summing responses from its three core items. It consists of empirically selected items measuring key aspects of service satisfaction, each rated on a 4-point Likert scale (1 = lowest satisfaction to 4 = highest, with directionality adjusted as needed). Total scores range from 3 to 12, with higher values indicating greater satisfaction; no reverse scoring or subscales are required.
Time frame: Administered at the end of treatment at 8 weeks.
The Credibility and Expectancy Questionnaire
The Credibility/Expectancy Questionnaire (CEQ) is a 6-item self-report measure assessing treatment credibility (items 1-3) and expectancy (items 4-6). Items 1-3 and 5 are rated 0 (not at all credible/logical) to 9 (extremely credible/logical), while items 4 and 6 are rated 0% to 100%; subscale scores are standardized and summed (credibility: 3-27 raw equivalent; expectancy similar), with total scores ranging 6-54 after standardization, where higher scores indicate greater credibility and positive outcome expectancy (better outcome).
Time frame: At enrollment
Modified Patient Global Impression of Change
The Modified Patient Global Impression of Change (mPGIC) adapts the standard single-item Patient Global Impression of Change (PGIC), a validated patient-reported outcome measure of overall perceived change since intervention, by assessing change across six specific domains. Each domain uses a single ordinal item rated on a 7-point scale: Very Much Improved (coded 1), Much Improved (2), Minimally Improved (3), No Change (4), Minimally Worse (5), Much Worse (6) or Very Much Worse (7). The range per domain is 0 (worst, Much Worse) to 5 (best, Very Much Improved), with higher scores indicating greater perceived improvement. Domains are analyzed individually as mean scores (no total computed), where values \<4 reflect net positive change. Domains include coping strategies, physical activity, social activity, level of stress, memory and thinking, and pain.
Time frame: At end of 8 week program (post test) and again at 3 month follow up visit.
Numerical Rating Scale
The Numerical Rating Scale (NRS) for pain intensity is an 11-point scale from 0 (no pain) to 10 (worst imaginable pain), assessing average pain over the past week. Higher scores indicate greater pain intensity (worse outcome), lower scores less pain (better); single-item total score.
Time frame: From enrollment to 3 months from the end of treatment at 8 weeks.
PROMIS Physical Function
The PROMIS Short Form V2.0 - Physical Function 8B (PROMIS PF 8B v2.0) is an 8-item patient-reported outcome measure assessing self-reported capability in physical activities, including upper extremity function (e.g., hand/arm tasks), lower extremity function (e.g., walking), central body function, and daily activities. It uses a 5-point Likert response scale per item: Without any difficulty (5), With little difficulty (4), With some difficulty (3), With much difficulty (2), or Unable to do/Cannot do (1). Raw total scores range from 8 (severe difficulty, worst outcome) to 40 (no difficulty, best outcome); these convert via scoring tables to T-scores (mean=50, SD=10 in U.S. population), where higher T-scores indicate better physical function. No subscales are computed; the total score reflects overall physical function. The T-score range for the PROMIS SF V1.2 is 10-65.
Time frame: From enrollment to 3 months from the end of treatment at 8 weeks.
PROMIS Anxiety
From enrollment to 3 months from the end of treatment at 8 weeks
Time frame: The PROMIS Short Form V1.0 - Emotional Distress Anxiety 8a (PROMIS Anxiety SF 8a v1.0) is an 8-item patient-reported outcome measure assessing self-reported anxiety symptoms over the past 7 days, including fear, nervousness, worry, dread, and feeling ten
PROMIS Emotional Support
The PROMIS Short Form V2.0 - Emotional Support 8a (PROMIS Emotional Support SF 8a v2.0) is an 8-item patient-reported outcome measure assessing perceived availability of supportive interpersonal relationships over the past 7 days, including listening, confiding, appreciation, understanding, and trust. It uses a 5-point Likert response scale per item: Never (1), Rarely (2), Sometimes (3), Often (4), or Always (5). Raw total scores range from 8 (minimal support, worst outcome) to 40 (strong support, best outcome); these convert via scoring tables to T-scores (mean=50, SD=10 in U.S. population), where higher T-scores indicate greater emotional support. No subscales are computed; the total score reflects overall perceived support. T-score range: 25-75 for the 8a short form.
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 Measure of Current Status Part A (MOCS-A) comprises 13 items rated 0 (cannot do at all) to 4 (extremely well), summed for total score 0-52, with four subscales: relaxation, tension awareness, assertiveness, coping confidence (higher total/subscale scores indicate better stress management ability, better outcome). Each item is 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.
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) is a 12-item scale rated 1 (rarely/not at all) to 4 (almost always), total score summed 12-48 (higher scores indicate greater mindfulness ability, better outcome); unidimensional total score. Scoring: Items 2, 6, and 7 are reverse-scored. After appropriate reversals, sum values for items 1-12. Higher values reflect greater mindful qualities.
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) sums 20 items rated 0 (never true) to 6 (always true) for total raw score 0-120, with two subscales: Activity Engagement (0-66) and Pain Willingness (0-54), both/totals higher indicating greater pain acceptance (better outcome).
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) consists of 10 items rated 0 (not at all confident) to 6 (completely confident), summed for total 0-60. Higher scores indicate greater self-efficacy despite pain (better outcome); single total score.
Time frame: From enrollment to 3 months from the end of treatment at 8 weeks
Pain Catastrophizing Scale
The Pain Catastrophizing Scale (PCS) sums 13 items rated 0 (not at all) to 4 (all the time) for total 0-52, with subscales: Rumination (0-16), Magnification (0-12), Helplessness (0-24); higher scores indicate greater catastrophizing (worse outcome).
Time frame: From enrollment to 3 months from the end of treatment at 8 weeks.
Tampa Kinesiophobia Scale
The Tampa Scale of Kinesiophobia (TSK-11) sums 11 items rated 1 (strongly disagree) to 4 (strongly agree), with no reverse-coded items. Total score range: 11-44 (higher scores greater kinesiophobia/fear of movement, worse outcome).
Time frame: From enrollment to 3 months from the end of treatment at 8 weeks
PROMIS Depression
The PROMIS Short Form V1.0 - Emotional Distress Depression 8b (PROMIS Depression SF 8b v1.0) is an 8-item patient-reported outcome measure assessing self-reported depressive symptoms over the past 7 days, including feelings of worthlessness, helplessness, sadness, failure, depression, unhappiness, and hopelessness. It uses a 5-point Likert response scale per item: Never (1), Rarely (2), Sometimes (3), Often (4), or Always (5). Raw total scores range from 8 (minimal depression, best outcome) to 40 (severe depression, worst outcome); these convert via scoring tables to T-scores (mean=50, SD=10 in U.S. population), where higher T-scores indicate greater depression severity. No subscales are computed; the total score reflects overall depressive distress. T-score range: 42-84.
Time frame: From enrollment to 3 months from the end of treatment at 8 weeks.
Telephone Interview for Cognitive Status (41-point version)
The Telephone Interview for Cognitive Status (41-point version) sums 11 items (e.g., orientation, memory, attention) for total score 0-41, with higher scores indicating better global cognitive function (better outcome).
Time frame: From enrollment to 3 months from the end of treatment at 8 weeks.
The Everyday Cognition Scale (12-item version)
The Everyday Cognition Scale (ECog-12) is a 12-item informant-rated questionnaire assessing self-reported changes in everyday cognitive and functional abilities, sensitive to early decline in domains like memory, executive function, and organization. Each item uses a 4-point ordinal scale: 1 = No change (better or same), 2 = Occasionally worse, 3 = Consistently worse, 4 = Much worse. Higher ratings indicate greater perceived decline; "don't know" responses are typically prorated or handled per study protocol. The total score is the mean (average) of the 12 item scores, accounting for any missing data by dividing the sum by completed items. Scores range from 1.0 (no decline) to 4.0 (maximum impairment), with means around 1.5-2.0 in cognitively unimpaired participants.
Time frame: From enrollment to 3 months from the end of treatment at 8 weeks.
Plan to share: Yes — An IPD collected throughout the trial.
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
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Massachusetts General Hospital