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NCT06493903 | RECRUITING | Osteoarthritis, Knee

Positive Minds Strong Joints for Knee Osteoarthritis
Sponsor:

Boston University Charles River Campus

Information provided by (Responsible Party):

Deepak Kumar

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).

Condition or disease

Osteoarthritis, Knee

Intervention/treatment

Positive Minds, Strong Joints

Phase

NA

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 Type : INTERVENTIONAL
Estimated Enrollment : 40 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Physical and Mental Health Intervention for Black Adults With Knee Osteoarthritis: A Feasibility Study
Actual Study Start Date : 2025-02-17
Estimated Primary Completion Date : 2026-06-30
Estimated Study Completion Date : 2026-12-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 50 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
INCLUSION CRITERIA
  • * Age≥50
  • * BMI ≤ 40 kg/m2
  • * Self-identify as Black (including African American)
  • * Knee pain ≥4/10 on a 11 numeric scale over the past week
  • * Scored 5 or more on either the Patient Health Questionnaire (PHQ-9) and/or the Generalized Anxiety Disorder 7-item Scale (GAD-7)
  • * Can speak and understand English at a sufficient level to understand the study procedures and informed consent
  • * Available for study duration
  • * Able to attend remote sessions
  • EXCLUSION CRITERIA
  • * Knee, hip or ankle replacement
  • * Intra-articular corticosteroid or hyaluronic acid knee injection within 3 months
  • * Knee surgery within past 6 months
  • * Currently receiving or received within 3-months any PT for knee OA
  • * Currently receiving or received within 3 months any mental health intervention (excluding pharmacologic treatments)
  • * Planning to initiate physical therapy for joint or low back pain in the next 3months
  • * Planning to initiate any mental health treatment (excluding pharmacologic treatments) in the next 1 month.
  • * Systemic inflammatory arthritis (e.g., rheumatoid arthritis)
  • * Neurologic conditions (e.g., stroke, Parkinson's disease, etc.)
  • * Contraindications to starting an exercise program.
  • * Suspected substance abuse
  • * Lack capacity to consent
  • * Pregnancy (self-report)
  • * Participation in another clinical trial for any joint or muscle pain
  • * Planning for a major surgery in the next 6 months
  • * Having high risk mental health symptoms (active suicidality, bipolar disorder, mania, psychosis, schizophrenia)
  • * Receiving chemotherapy or radiation therapy for cancer (except non-melanoma skin cancer)
Positive Minds Strong Joints for Knee Osteoarthritis

Location Details

NCT06493903

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Massachusetts

Boston University

Boston, Massachusetts, United States, 02215