Comparing the Effectiveness of Two Programs for Pain Management and Cognitive Health in Older Black Adults

February 13, 2024 updated by: Olivia I.Okereke, MD, Massachusetts General Hospital

Comorbidity of Chronic Pain and Early Cognitive Decline Among Older, Community-based Black Adults: Comparative Effectiveness of Mindfulness-Based Cognitive Therapy With Walking (MBCT) vs Active Living Every Day (ALED)

The investigators aim to conduct a randomized controlled trial to compare two symptom-management programs for Black older adults with early cognitive decline (self-reported confirmed by testing) and chronic pain. The programs are Mindfulness-Based Cognitive Therapy with Walking (MBCT+w) and Active Living Every Day (ALED). The investigators will assess how each program may help in improving physical, cognitive, and emotional function. The investigators will also assess whether improvements in outcomes from the two programs are maintained through a 6-month follow-up.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The investigators aim to conduct a randomized controlled trial to compare two symptom-management programs for Black older adults with early cognitive decline (self-reported or confirmed by testing) and chronic pain. The programs are Mindfulness-Based Cognitive Therapy with Walking (MBCT+w) and Active Living Every Day (ALED). The investigators will assess how each program may help in improving physical, cognitive, and emotional function outcomes. The investigators will also assess whether improvements in outcomes from the two programs are maintained through a 6-month follow-up.

The program MBCT+w is focused on learning about managing chronic pain and early cognitive decline and strategies to become more active. The ALED program focuses on learning and understanding the process of successful lifestyle change, incorporating physical activity in your day-to-day life, and strategies to manage daily activity.

The MBCT+w group meets for eight sessions for 90-minutes, and the ALED group meets for twelve sessions for 60-minutes over the secure Zoom platform. Each group has 10-12 participants. Participants receive a treatment manual. The investigators will assess how each program may help in improving physical, cognitive, and emotional function outcomes. Outcomes will be assessed at 3 points: baseline, post program, and 6-month follow-up. Assessments involve self-report questionnaires, a walk test, and a neuropsychological exam. The investigators will assess whether improvements in outcomes from the two programs are maintained through a 6-month follow-up.

Study Type

Interventional

Enrollment (Estimated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Black adults, male and females, age 50 or older
  • Have nonmalignant musculoskeletal chronic pain for more than three months
  • Reports early cognitive decline (subjective and objective)
  • Telephone Interview for Cognitive Status-30 score greater than or equal to 17
  • Functional Activities Questionnaire score less than 9
  • English fluency/literacy
  • Free of concurrent psychotropic or pain medication for at least 2 weeks prior to initiation of treatment, OR stable on current psychotropic or pain medication for a minimum of 6 weeks and willing to maintain stable dose
  • Cleared by medical doctor for study participation and no self-reported concerns about physical functioning on the revised Physical Activity Readiness Questionnaire (PAR-Q; score 0)

Exclusion Criteria:

  • Diagnosed with dementia or neurodegenerative disease
  • Regular use of nonpharmacological pain management
  • Diagnosed with serious mental illness or substance abuse
  • Current suicidal ideation on self-report
  • Engagement of regular exercise for more than 30 minutes daily
  • Unable to walk

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mindfulness-Based Cognitive Therapy With Walking (MBCT+w)
MBCT+w uses a multimodal approach to introduce and reinforce new skills, including didactics, in-session activities, discussions and weekly practice assignments (homework). The MBCT+w sessions teach skills and strategies to manage early cognitive concerns and chronic pain. The format is an 8-week program with 90-minute weekly meetings that will focus on relaxation response strategies, cognitive behavioral training, positive psychology and mind-body interactions. MBCT+w uses a wrist-worn digital monitoring device (ActiGraph) for recording of physical activity.
Behavioral: MBCT+w
MBCT+w uses a multimodal approach to introduce and reinforce new skills, including didactics, in-session activities, discussions and weekly practice assignments (homework). The MBCT+w sessions teach skills and strategies to manage early cognitive concerns and chronic pain. The format is an 8-week program with 90-minute weekly meetings that will focus on relaxation response strategies, cognitive behavioral training, positive psychology and mind-body interactions. MBCT+w uses a wrist-worn digital monitoring device (ActiGraph) for recording of physical activity.
Active Comparator: Active Living Every Day (ALED)
ALED is a behavior change program. ALED offers different options to traditional exercise program to help participants overcome barriers to physical activity and increase their physical activity. The format is a 12-week program with 60-minute sessions that include a short lecture and group discussions to help participants set goals, decrease barriers to exercise, and find an activity they enjoy. The ALED program is conducted in the same format as MBCT+w, but participants are not taught the mind-body, walking or cognitive-behavioral skills. ALED will also use a wrist-worn digital monitoring device (ActiGraph) for recording of physical activity.
Behavioral: ALED
ALED is a behavior change program. ALED offers different options to traditional exercise program to help participants overcome barriers to physical activity and increase their physical activity. The format is a 12-week program with 60-minute sessions that include a short lecture and group discussions to help participants set goals, decrease barriers to exercise, and find an activity they enjoy. The ALED program is conducted in the same format as MBCT+w, but participants are not taught the mind-body, walking or cognitive-behavioral skills. ALED will also use a wrist-worn digital monitoring device (ActiGraph) for recording of physical activity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function
Time Frame: 0 Weeks, 12 Weeks, 6 Months
Change in participant's self-reported performance of everyday physical activities, with items ranging from 1-4. Higher T scores indicate greater physical function.
0 Weeks, 12 Weeks, 6 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ActiGraph GT9X Link Accelerometer
Time Frame: 0 Weeks, 12 Weeks, 6 Months
Measure the change in steps during the 7 days preceding baseline assessment, throughout intervention period, and 7 days preceding 6-month follow-up.
0 Weeks, 12 Weeks, 6 Months
Six-minute walk test (6MWT)
Time Frame: 0 Weeks, 12 Weeks, 6 Months
Assesses distance walked in 6 minutes.
0 Weeks, 12 Weeks, 6 Months
Montreal Cognitive Assessment (MoCA)
Time Frame: 0 Weeks, 12 Weeks, 6 Months
A comprehensive test that assesses eight cognitive abilities (orientation, short-term memory, executive function, clock drawing, animal naming, language abilities, abstraction, and attention). Higher total scores (0-30) indicate greater cognitive functioning.
0 Weeks, 12 Weeks, 6 Months
Everyday Cognitive Scale (eCog-12)
Time Frame: 0 Weeks, 12 Weeks, 6 Months
Rating of participant's self-reported cognitively mediated functional abilities, with items ranging 1-5. Scores are calculated by averaging the 12 items, and range 1-5, with higher scores indicating greater cognitive decline.
0 Weeks, 12 Weeks, 6 Months
PROMIS Depression
Time Frame: 0 Weeks, 12 Weeks, 6 Months
Rating of participant's self-reported negative mood, social cognition and views of self, with items ranging from 1-5. Higher T scores indicate high levels of depression.
0 Weeks, 12 Weeks, 6 Months
PROMIS Anxiety
Time Frame: 0 Weeks, 12 Weeks, 6 Months
Rating of participant's self-reported fear, anxious, hyperarousal and somatic symptoms pertaining to arousal, with items ranging from 1-5. Higher T scores indicate higher levels of anxiety.
0 Weeks, 12 Weeks, 6 Months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numerical Rating Scale (NRS)
Time Frame: 0 Weeks, 12 Weeks, 6 Months
Rating of participant's self-reported pain at rest and with activity using a Likert Scale with 0 being no pain and 10 being worst possible pain.
0 Weeks, 12 Weeks, 6 Months
UCLA loneliness scale 8-item (UCLA-8)
Time Frame: 0 Weeks, 12 Weeks, 6 Months
Rating of participant's self-reported subjective feelings of loneliness and social isolation, with items ranging 0-3. Higher scores indicate higher feelings of loneliness.
0 Weeks, 12 Weeks, 6 Months
PROMIS Emotional Support v4a
Time Frame: 0 Weeks, 12 Weeks, 6 Months
Rating of participant's self-reported subjective feelings of emotional support from others, with items ranging 1-5. Higher T scores indicate higher emotional support.
0 Weeks, 12 Weeks, 6 Months
Zarit Burden Interview (12-item)
Time Frame: 0 Weeks, 12 Weeks, 6 Months
Rating of caregiver's self-reported subjective feelings of his or her levels of burden for caring for a person with a particular diagnosis, with items ranging 0-4. Higher scores indicate greater feelings of burden.
0 Weeks, 12 Weeks, 6 Months
Caregiver Strain Questionnaire Short Form
Time Frame: 0 Weeks, 12 Weeks, 6 Months
Rating of caregiver's self-reported subjective feelings of strain experienced with sleep, finances, physical movements, and emotional adjustments, with items ranging 0-1. Higher scores indicate greater feelings of strain.
0 Weeks, 12 Weeks, 6 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Investigators

  • Principal Investigator: Olivia Okereke, MD, MS, Massachusetts General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2024

Primary Completion (Estimated)

August 1, 2028

Study Completion (Estimated)

November 1, 2028

Study Registration Dates

First Submitted

January 30, 2024

First Submitted That Met QC Criteria

January 30, 2024

First Posted (Actual)

February 7, 2024

Study Record Updates

Last Update Posted (Actual)

February 14, 2024

Last Update Submitted That Met QC Criteria

February 13, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024P000002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Pain

Clinical Trials on MBCT+w

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Benin

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe