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
- Conditions
- Chronic PainEarly Cognitive Decline
- Registration Number
- NCT07210398
- Lead Sponsor
- Massachusetts General Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 9
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method The Credibility and Expectancy Questionnaire From enrollment to 3 months from the end of treatment at 8 weeks 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.
The Client Satisfaction Questionnaire Administered at the end of treatment at 8 weeks and at the three month follow up visit Three item scale measuring patient satisfaction with the program. Scores for each item range from 1 (unsatisfied) to 4 (very satisfied).
Modified Patient Global Impression of Change At end of 8 week program (post test) and again at 3 month follow up visit. Measures participant impressions of overall change with one being very much improved and eight being very much worse. Lower scores indicate improvement.
- Secondary Outcome Measures
Name Time Method 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 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.
Numerical Rating Scale From enrollment to 3 months from the end of treatment at 8 weeks. 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.
PROMIS Physical Function From enrollment to 3 months from the end of treatment at 8 weeks. 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.
PROMIS Anxiety From enrollment to 3 months from the end of treatment at 8 weeks 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.
PROMIS Emotional Support From enrollment to 3 months from the end of treatment at 8 weeks 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.
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) 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.
Chronic Pain Acceptance Questionnaire From enrollment to 3 months from the end of treatment at 8 weeks. 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).
Pain Self-Efficacy Questionnaire From enrollment to 3 months from the end of treatment at 8 weeks. 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).
Pain Catastrophizing Scale From enrollment to 3 months from the end of treatment at 8 weeks. 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.
Tampa Kinesiophobia Scale From enrollment to 3 months from the end of treatment at 8 weeks. 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.
PROMIS Depression From enrollment to 3 months from the end of treatment at 8 weeks. The PROMIS Depression scale is a self-reported questionnaire designed to assess symptoms of depression over the previous seven days, focusing on negative mood, self-perception, and social cognition while excluding somatic symptoms like appetite or sleep disturbances.
Telephone Interview for Cognitive Status (41-point version) From enrollment to 3 months from the end of treatment at 8 weeks. A standardized telephone-based screening tool used to assess global cognitive functioning, especially among older adults or those unable to attend in-person exams.
The Everyday Cognition Scale (12-item version) From enrollment to 3 months from the end of treatment at 8 weeks. A brief, informant-rated questionnaire designed to assess subtle changes in the everyday cognitive functioning of older adults, aiding in the detection of cognitive impairment such as mild cognitive impairment (MCI) and dementia.
Trial Locations
- Locations (1)
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Massachusetts General Hospital🇺🇸Boston, Massachusetts, United States