Ignite Creation Date:
2025-12-24 @ 7:39 PM
Ignite Modification Date:
2025-12-31 @ 7:59 AM
Study NCT ID:
NCT06493903
Status:
RECRUITING
Last Update Posted:
2025-05-16
First Post:
2024-07-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Positive Minds Strong Joints for Knee Osteoarthritis
Sponsor:
Boston University Charles River Campus
Organization:
Study Overview
Official Title:
Physical and Mental Health Intervention for Black Adults With Knee Osteoarthritis: A Feasibility Study
Status:
RECRUITING
Status Verified Date:
2025-05
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:
PMSJ
Brief Summary:
The aim of this research study is to test the feasibility of a physical and mental health intervention (Positive Minds, Strong Joints or PMSJ) for Black adults with knee osteoarthritis (OA).
Detailed Description:
In this feasibility study, at least 20 and up to 40 Black Adults will be enrolled to receive PMSJ intervention. Participants who will take part in this research study will be in it for about 26 weeks. Participants will receive a one-hour individual session of psychoeducation, mindfulness, and cognitive behavior therapy skills for 10 weeks via a HIPAA-protected zoom video-call or over the telephone. In addition, they will receive a community-based group exercise and pain education program once a week for 10 weeks. Participants will also continue to receive their usual care. Participants will be asked to take surveys at five time points (i.e.) before the start of the 10-week intervention (baseline visit), mid-way through the intervention (week 5), end of the 10-week intervention (post-intervention), 6 weeks after the intervention (week 16) and 12 weeks after the intervention (week 22). Brief surveys will also be completed weekly throughout the study. The surveys will be about pain, function, quality of life, mood, social support, sleep, etc. At baseline and post-intervention visits, all participants will also be asked to wear a small movement sensor on their lower back for 7 days of continuous movement and physical activity monitoring. During both of these 7-day periods, participants will complete a single remote assessment of their walking. Feasibility of the intervention will be determined post-intervention by outcome measures such as recruitment rate, retention rate, and adherence.
Study Oversight
Has Oversight DMC:
False
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?:
False
Is an FDA AA801 Violation?: