Trial Outcomes & Findings for Mindfulness-based Cognitive Therapy for the Chronic Pain-early Cognitive Decline Co-morbidity Among Older Black Individuals in the Community; The Feeling of Being Open Pilot (NCT NCT07210398)

NCT ID: NCT07210398

Last Updated: 2026-04-17

Results Overview

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).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

9 participants

Primary outcome timeframe

At enrollment

Results posted on

2026-04-17

Participant Flow

Participant milestones

Participant milestones
Measure
Mindfulness-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.
Overall Study
STARTED
9
Overall Study
COMPLETED
9
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Mindfulness-based Cognitive Therapy for the Chronic Pain-early Cognitive Decline Co-morbidity Among Older Black Individuals in the Community; The Feeling of Being Open Pilot

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Mindfulness-based Cognitive Therapy
n=9 Participants
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.
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=130 Participants
Race (NIH/OMB)
Asian
0 Participants
n=130 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=130 Participants
Race (NIH/OMB)
Black or African American
8 Participants
n=130 Participants
Race (NIH/OMB)
White
1 Participants
n=130 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=130 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=130 Participants
Sex: Female, Male
Female
9 Participants
n=130 Participants
Sex: Female, Male
Male
0 Participants
n=130 Participants
Region of Enrollment
United States
9 Participants
n=130 Participants
Age, Continuous
74 Year
STANDARD_DEVIATION 8.31 • n=130 Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure
Mindfulness-based Cognitive Therapy
n=9 Participants
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.
The Credibility and Expectancy Questionnaire
35.07 Total Score
Standard Deviation 5.94

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Mindfulness-based Cognitive Therapy
n=9 Participants
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.
The Client Satisfaction Questionnaire
11.56 Total Score
Standard Deviation 0.73

PRIMARY outcome

Timeframe: 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 6-point scale: Very Much Improved (coded 5), Much Improved (4), Minimally Improved (3), No Change (2), Minimally Worse (1), or Much Worse (0). 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 \>2.5 reflect net positive change. Domains include coping strategies, physical activity, social activity, level of stress, memory and thinking, and pain.

Outcome measures

Outcome measures
Measure
Mindfulness-based Cognitive Therapy
n=9 Participants
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.
Modified Patient Global Impression of Change
Physical Activity Post-Test
4.33 Score
Standard Deviation 1.00
Modified Patient Global Impression of Change
Coping Strategies Post-Test
4.11 Score
Standard Deviation 1.05
Modified Patient Global Impression of Change
Stress Post-Test
4.11 Score
Standard Deviation 1.05
Modified Patient Global Impression of Change
Social Activity Post-Test
4.11 Score
Standard Deviation 1.27
Modified Patient Global Impression of Change
Pain Post-Test
4.00 Score
Standard Deviation 0.87
Modified Patient Global Impression of Change
Memory/Thinking Post-Test
3.78 Score
Standard Deviation 0.83
Modified Patient Global Impression of Change
Coping Strategies Follow-Up
4.11 Score
Standard Deviation 1.05
Modified Patient Global Impression of Change
Stress Follow-Up
4.00 Score
Standard Deviation 1.00
Modified Patient Global Impression of Change
Social Activity Follow-Up
3.56 Score
Standard Deviation 1.13
Modified Patient Global Impression of Change
Memory/Thinking Follow-Up
3.33 Score
Standard Deviation 1.32
Modified Patient Global Impression of Change
Physical Activity Follow-Up
3.11 Score
Standard Deviation 1.45
Modified Patient Global Impression of Change
Pain Follow-Up
3.44 Score
Standard Deviation 1.33

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Mindfulness-based Cognitive Therapy
n=9 Participants
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.
Numerical Rating Scale
Baseline
7.11 Score
Standard Deviation 2.09 • Interval 5.67 to 8.56
Numerical Rating Scale
Post-Test
7.33 Score
Standard Deviation 1.87 • Interval 6.04 to 8.62
Numerical Rating Scale
Follow-up
7.44 Score
Standard Deviation 2.07 • Interval 6.0 to 8.88

SECONDARY outcome

Timeframe: From enrollment to 3 months from the end of treatment at 8 weeks.

The PROMIS Short Form V1.2 - Physical Function 8B (PROMIS PF 8B v1.2) 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 (1), With little difficulty (2), With some difficulty (3), With much difficulty (4), or Unable to do/Cannot do (5). Raw total scores range from 8 (no difficulty, best outcome) to 40 (severe difficulty, worst 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.

Outcome measures

Outcome measures
Measure
Mindfulness-based Cognitive Therapy
n=9 Participants
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.
PROMIS Physical Function
Post-Test
31.8 T-score
Standard Deviation 1.3 • Interval 19.61 to 22.17
PROMIS Physical Function
Follow-Up
32.6 T-score
Standard Deviation 2.9 • Interval 17.19 to 24.81
PROMIS Physical Function
Baseline
32.5 T-score
Standard Deviation 1.3 • Interval 19.61 to 22.17

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Mindfulness-based Cognitive Therapy
n=9 Participants
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.
PROMIS Anxiety
Follow-Up
66.4 T-score
Standard Deviation 3.0 • Interval 23.27 to 32.28
PROMIS Anxiety
Baseline
64.8 T-score
Standard Deviation 1.6 • Interval 22.67 to 29.77
PROMIS Anxiety
Post-Test
62.7 T-score
Standard Deviation 6.2 • Interval 22.67 to 29.77

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Mindfulness-based Cognitive Therapy
n=9 Participants
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.
PROMIS Emotional Support
Baseline
55.2 T-score
Standard Deviation 2.1 • Interval 21.49 to 33.63
PROMIS Emotional Support
Post-test
53.8 T-score
Standard Deviation 2.3 • Interval 18.79 to 30.99
PROMIS Emotional Support
Follow-up
55.8 T-score
Standard Deviation 2.8 • Interval 22.1 to 34.35

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Mindfulness-based Cognitive Therapy
n=9 Participants
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.
Measure of Current Status Part A
Post-Test
15.56 Total Score
Standard Deviation 6.88
Measure of Current Status Part A
Follow-Up
17.11 Total Score
Standard Deviation 5.78
Measure of Current Status Part A
Baseline
16.67 Total Score
Standard Deviation 4.87

SECONDARY outcome

Timeframe: 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 0 (rarely/not at all) to 3 (almost always), total score summed 0-36 (higher scores indicate greater mindfulness ability, better outcome); unidimensional total score.

Outcome measures

Outcome measures
Measure
Mindfulness-based Cognitive Therapy
n=9 Participants
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.
Cognitive and Affective Mindfulness Scale-Revised
Baseline
28.89 Total Score
Standard Deviation 7.14
Cognitive and Affective Mindfulness Scale-Revised
Post-Test
27.56 Total Score
Standard Deviation 6.70
Cognitive and Affective Mindfulness Scale-Revised
Follow-Up
28.56 Total Score
Standard Deviation 6.97

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure
Mindfulness-based Cognitive Therapy
n=9 Participants
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.
Chronic Pain Acceptance Questionnaire
Baseline
53.11 Total Score
Standard Deviation 16.32
Chronic Pain Acceptance Questionnaire
Post-Test
55.56 Total Score
Standard Deviation 18.39
Chronic Pain Acceptance Questionnaire
Follow-Up
52.78 Total Score
Standard Deviation 20.42

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Mindfulness-based Cognitive Therapy
n=9 Participants
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.
Pain Self-Efficacy Questionnaire
Baseline
32.00 Total Score
Standard Deviation 7.26
Pain Self-Efficacy Questionnaire
Post-Test
32.56 Total Score
Standard Deviation 7.36
Pain Self-Efficacy Questionnaire
Follow-Up
32.44 Total Score
Standard Deviation 7.40

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure
Mindfulness-based Cognitive Therapy
n=9 Participants
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.
Pain Catastrophizing Scale
Baseline
28.89 Total Score
Standard Deviation 10.12
Pain Catastrophizing Scale
Post-Test
25.22 Total Score
Standard Deviation 11.82
Pain Catastrophizing Scale
Follow-Up
29.22 Total Score
Standard Deviation 5.42

SECONDARY outcome

Timeframe: From enrollment to 3 months from the end of treatment at 8 weeks.

The Tampa Scale of Kinesiophobia (TSK-17) sums 17 items rated 1 (strongly disagree) to 4 (strongly agree), with reverse on items 4, 8, 12, and 16. Total score range: 17-68 (higher scores greater kinesiophobia/fear of movement, worse outcome).

Outcome measures

Outcome measures
Measure
Mindfulness-based Cognitive Therapy
n=9 Participants
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.
Tampa Kinesiophobia Scale
Baseline
31.22 Total Score
Standard Deviation 8.52
Tampa Kinesiophobia Scale
Post-Test
4133 Total Score
Standard Deviation 8.34
Tampa Kinesiophobia Scale
Follow-Up
33.67 Total Score
Standard Deviation 5.56

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Mindfulness-based Cognitive Therapy
n=9 Participants
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.
PROMIS Depression
Baseline
71.4 T-score
Standard Deviation 3.9
PROMIS Depression
Post-Test
71.1 T-score
Standard Deviation 3.8
PROMIS Depression
Follow-Up
72.4 T-score
Standard Deviation 4.3

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure
Mindfulness-based Cognitive Therapy
n=9 Participants
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.
Telephone Interview for Cognitive Status (41-point Version)
Baseline
29.11 Total Score
Standard Deviation 2.09
Telephone Interview for Cognitive Status (41-point Version)
Post-Test
28.89 Total Score
Standard Deviation 2.32
Telephone Interview for Cognitive Status (41-point Version)
Follow-Up
30.00 Total Score
Standard Deviation 5.56

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure
Mindfulness-based Cognitive Therapy
n=9 Participants
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.
The Everyday Cognition Scale (12-item Version)
Post-Test
2.463 Score Mean
Standard Deviation 0.356
The Everyday Cognition Scale (12-item Version)
Follow-Up
2.472 Score Mean
Standard Deviation 0.349
The Everyday Cognition Scale (12-item Version)
Baseline
2.481 Score Mean
Standard Deviation 0.266

Adverse Events

Mindfulness-based Cognitive Therapy

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Tony V Pham

Massachusetts General Hospital/Harvard Medical School

Phone: 6177260469

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place