Chronic Pain, Early Cognitive Decline
Conditions
Keywords
mindfulness-based cognitive therapy, mind-body, chronic pain, early cognitive decline, older adult
Brief summary
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?
Detailed 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.
Interventions
BEHAVIORALMindfulness-based cognitive therapy
The delivered intervention is mindfulness-based cognitive therapy adapted for the chronic pain and cognitive decline comorbidity among older Black adults. Mindfulness-based cognitive therapy (MBCT) is a structured psychotherapy that integrates mindfulness practices with cognitive behavioral therapy techniques. This adapted MBCT is delivered as an 8-week group-based program with each weekly session lasting about 1 hour. Sessions occur once per week, supplemented by daily home practice of 40-60 minutes, 6 days a week, involving guided meditations, body scans, and mindful activities to reinforce skills.
Sponsors
Massachusetts General Hospital
National Center for Advancing Translational Sciences (NCATS)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 120 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Credibility and Expectancy Questionnaire | At enrollment | 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). |
| The Client Satisfaction Questionnaire | Administered at the end of treatment at 8 weeks. | 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. |
| Modified Patient Global Impression of Change | At end of 8 week program (post test) and again at 3 month follow up visit. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Numerical Rating Scale | From enrollment to 3 months from the end of treatment at 8 weeks. | 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. |
| PROMIS Physical Function | From enrollment to 3 months from the end of treatment at 8 weeks. | 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. |
| PROMIS Anxiety | From enrollment to 3 months from the end of treatment at 8 weeks | 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 tense or restless. 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 anxiety, best outcome) to 40 (severe anxiety, worst outcome); these convert via scoring tables to T-scores (mean=50, SD=10 in U.S. population), where higher T-scores indicate greater anxiety severity. No subscales are computed; the total score reflects overall anxiety distress. T-score range: 28-82 for the 8a short form. |
| PROMIS Emotional Support | From enrollment to 3 months from the end of treatment at 8 weeks | 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. |
| Measure of Current Status Part A | From enrollment to 3 months from the end of treatment at 8 weeks. | 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. |
| Cognitive and Affective Mindfulness Scale-Revised | From enrollment to 3 months from the end of treatment at 8 weeks. | 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. ' |
| Chronic Pain Acceptance Questionnaire | From enrollment to 3 months from the end of treatment at 8 weeks. | 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). |
| Pain Self-Efficacy Questionnaire | From enrollment to 3 months from the end of treatment at 8 weeks. | 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. |
| Pain Catastrophizing Scale | From enrollment to 3 months from the end of treatment at 8 weeks. | 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). |
| Tampa Kinesiophobia Scale | From enrollment to 3 months from the end of treatment at 8 weeks. | 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). |
| PROMIS Depression | From enrollment to 3 months from the end of treatment at 8 weeks. | 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. |
| Telephone Interview for Cognitive Status (41-point Version) | From enrollment to 3 months from the end of treatment at 8 weeks. | 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). |
| The Everyday Cognition Scale (12-item Version) | From enrollment to 3 months from the end of treatment at 8 weeks. | 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 u |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORTony V Pham
MGH
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 74 Year STANDARD_DEVIATION 8.31 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 8 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment United States | 9 Participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 9 |
| other Total, other adverse events | 0 / 9 |
| serious Total, serious adverse events | 0 / 9 |
Outcome results
None listed