Ignite Creation Date:
2024-05-06 @ 8:04 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06246929
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-14
First Post:
2024-01-30
Brief Title:
Comparing the Effectiveness of Two Programs for Pain Management and Cognitive Health in Older Black Adults
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 MBCTw 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
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 MBCTw 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 MBCTw 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 MBCTw 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
The program MBCTw 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 MBCTw 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None