Ignite Creation Date:
2024-05-06 @ 5:38 PM
Last Modification Date:
2024-10-26 @ 2:32 PM
Study NCT ID:
NCT05373745
Status:
RECRUITING
Last Update Posted:
2023-03-03
First Post:
2022-04-15
Brief Title:
Managing Pain and Cognitions in Older Adults With Early Cognitive Decline and Chronic Pain
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Addressing the Chronic Pain-Early Cognitive Decline Comorbidity Among Older Adults The Active Brains Study
Status:
RECRUITING
Status Verified Date:
2023-03
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 fully powered randomized controlled trial to compare the efficacy of two symptom management programs for older adults with early cognitive decline either self-reported or confirmed by testing and chronic pain Active Brains 1 and Active Brains 2 The investigators will assess how each program may help in improving multimodal physical cognitive and emotional function The investigators will also assess whether improvements in outcomes from the two programs are maintained through 6-months follow-up The investigators will also explore whether improvements in outcomes are mediated by nonadaptive pain reactions adaptive coping social factors and compensatory strategies and modified by demographic and clinical predictors Both programs will be delivered virtually Zoom
Detailed Description:
The investigators aim to conduct a fully powered randomized controlled trial to establish efficacy of two symptom management programs for older adults with early cognitive decline either self-reported or confirmed by testing and chronic pain Active Brains 1 and Active Brains 2 The investigators will assess how the two programs may help in improving multimodal physical cognitive and emotional function The investigators will also assess whether improvements in outcomes are maintained through 6-months follow-up The investigators will also explore whether improvements in outcomes are mediated by nonadaptive pain reactions adaptive coping social factors and compensatory strategies and modified by demographic and clinical predictors and type of early cognitive decline Both programs will be delivered virtually Zoom
Each group meets for eight 90 minutes sessions over the secure Zoom platform Each group has 5-8 participants Participants receive a treatment manual There are 3 assessment points baseline post program and 6-month follow-up Assessments involve self-report questionnaires a walk test and a neuropsychological evaluation
Each group meets for eight 90 minutes sessions over the secure Zoom platform Each group has 5-8 participants Participants receive a treatment manual There are 3 assessment points baseline post program and 6-month follow-up Assessments involve self-report questionnaires a walk test and a neuropsychological evaluation
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