N/A
N=9
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
Chronic Pain · Early Cognitive Decline
Bottom Line
View on ClinicalTrials.gov: NCT07210398 ↗Enrolled (actual)
9
Serious AEs
0.0%
Results posted
Apr 2026
Primary outcome: Primary: The Credibility and Expectancy Questionnaire — 35.07 Total Score
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Mindfulness-based cognitive therapy (Behavioral)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Jul 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Credibility and Expectancy Questionnaire |
35.07 | — |
| PRIMARY The Client Satisfaction Questionnaire |
11.56 | — |
| PRIMARY Modified Patient Global Impression of Change |
4.33; 4.11; 4.11; 4.11; 4.00; 3.78 | — |
| SECONDARY Numerical Rating Scale |
7.11; 7.33; 7.44 | 0.169 |
| SECONDARY PROMIS Physical Function |
31.8; 32.6; 32.5 | 0.022 sig |
| SECONDARY PROMIS Anxiety |
64.8; 62.7; 66.4 | 0.020 sig |
| SECONDARY PROMIS Emotional Support |
55.2; 53.8; 55.8 | 0.048 sig |
| SECONDARY Measure of Current Status Part A |
16.67; 15.56; 17.11 | 0.302 |
| SECONDARY Cognitive and Affective Mindfulness Scale-Revised |
28.89; 27.56; 28.56 | 0.029 sig |
| SECONDARY Chronic Pain Acceptance Questionnaire |
53.11; 55.56; 52.78 | 0.113 |
| SECONDARY Pain Self-Efficacy Questionnaire |
32.00; 32.56; 32.44 | 0.013 sig |
| SECONDARY Pain Catastrophizing Scale |
28.89; 25.22; 29.22 | 0.0384 sig |
| SECONDARY Tampa Kinesiophobia Scale |
31.22; 4133; 33.67 | 0.0103 sig |
| SECONDARY PROMIS Depression |
71.4; 71.1; 72.4 | 0.169 |
| SECONDARY Telephone Interview for Cognitive Status (41-point Version) |
29.11; 28.89; 30.00 | 0.1690 |
| SECONDARY The Everyday Cognition Scale (12-item Version) |
2.481; 2.463; 2.472 | 0.708 |
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?
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT07210398). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.