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

Chronic Pain Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06246929
• Other study ID #: 2024P000002
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2024
• Est. completion date: November 1, 2028

Study information

• Verified date: February 2024
• Source: Massachusetts General Hospital
• Contact: Fatima Fontes, BA
• Phone: 6177261199
• Email: ffontes[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: November 1, 2028
• Est. primary completion date: August 1, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Cognitive Dysfunction
• Mild Cognitive Impairment
• Older Adults
• Physical Activity

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Numerical Rating Scale (NRS)	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
Other	UCLA loneliness scale 8-item (UCLA-8)	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
Other	PROMIS Emotional Support v4a	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
Other	Zarit Burden Interview (12-item)	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
Other	Caregiver Strain Questionnaire Short Form	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
Primary	Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function	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	ActiGraph GT9X Link Accelerometer	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
Secondary	Six-minute walk test (6MWT)	Assesses distance walked in 6 minutes.	0 Weeks, 12 Weeks, 6 Months
Secondary	Montreal Cognitive Assessment (MoCA)	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
Secondary	Everyday Cognitive Scale (eCog-12)	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
Secondary	PROMIS Depression	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
Secondary	PROMIS Anxiety	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

External Links

•   Development of a Novel Mind-Body Activity and Pain Management Program for Older Adults With Cognitive Decline
•   Feasibility Randomized Controlled Trial of a Mind-Body Activity Program for Older Adults With Chronic Pain and Cognitive Decline: The Virtual "Active Brains" Study
•   Feasibility Trial of a Mind-Body Activity Pain Management Program for Older Adults With Cognitive Decline
•   Live Video Adaptations to a Mind-Body Activity Program for Chronic Pain and Cognitive Decline: Protocol for the Virtual Active Brains Study