Positive Minds Strong Joints for Knee Osteoarthritis

NCT06493903 | Recruiting

• 1 other identifier: 7517
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

Osteoarthritis, Knee

Keywords

chronic pain; depression; anxiety; exercise; cognitive behavioral therapy; Black adults

Outcome Measures

Primary Outcomes (5)

• Recruitment Rate

  Number of participants enrolled out of those screened

  Throughout the recruitment process

• Retention

  Proportion of participants who complete patient-reported outcome surveys at 10 week timepoint

  From the start of the study to end of the 10 week intervention

• Attendance

  Proportion of participants that attended at least 80% of intervention sessions

  During 10 weeks intervention period

• Satisfaction with treatment

  Custom 2-item (0-10 scale) to determine satisfaction with individual components of the intervention (i.e., Positive Minds, Strong Joints). There are 2 items and each item is scored separately. Higher scores for each item mean greater satisfaction for that dimension.

  week 10 and week 22

• Participant Feedback

  Custom survey asking the participants to provide feedback on a 5-point scale from very poor to excellent on various aspects of the intervention including content, interventionists, group aspects, overall rating, etc.

  week 10 and week 22

Secondary Outcomes (16)

• Knee Injury and Osteoarthritis Outcome Score

  Baseline, week 5, week 10, week 16 and week 22

• Patient Health Questionnaire 9-item

  Baseline, week 5, week 10, week 16 and week 22

• Generalized anxiety 7-item scale

  Baseline, week 5, week 10, week 16 and week 22

• Arthritis Self Efficacy Scale

  Baseline, week 10, and week 22

• Fear Avoidance Beliefs Questionnaire - Physical Activity

  Baseline and week 10

Study Arms (1)

Positive Minds Strong Joints

EXPERIMENTAL

Participants will receive an individual mental health intervention through a zoom video-call once a week for 10 weeks and a community-based group exercise intervention once a week for 10 weeks.

Behavioral: Positive Minds, Strong Joints

Interventions

Positive Minds, Strong Joints BEHAVIORAL

In this10-week physical and mental health intervention, participants will receive recommended exercise intervention and evidence-based mental health intervention for pain, depression and anxiety.

Positive Minds Strong Joints

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston University Charles River Campus: lead
• Rheumatology Research Foundation: collaborator

Study Sites (1)

Boston University

Boston, Massachusetts, 02215, United States

RECRUITING

Related Publications (8)

• Bannuru RR, Osani MC, Vaysbrot EE, Arden NK, Bennell K, Bierma-Zeinstra SMA, Kraus VB, Lohmander LS, Abbott JH, Bhandari M, Blanco FJ, Espinosa R, Haugen IK, Lin J, Mandl LA, Moilanen E, Nakamura N, Snyder-Mackler L, Trojian T, Underwood M, McAlindon TE. OARSI guidelines for the non-surgical management of knee, hip, and polyarticular osteoarthritis. Osteoarthritis Cartilage. 2019 Nov;27(11):1578-1589. doi: 10.1016/j.joca.2019.06.011. Epub 2019 Jul 3.

  PMID: 31278997 BACKGROUND

• Dillon CF, Rasch EK, Gu Q, Hirsch R. Prevalence of knee osteoarthritis in the United States: arthritis data from the Third National Health and Nutrition Examination Survey 1991-94. J Rheumatol. 2006 Nov;33(11):2271-9. Epub 2006 Oct 1.

  PMID: 17013996 BACKGROUND

• Iversen MD, Schwartz TA, von Heideken J, Callahan LF, Golightly YM, Goode A, Hill C, Huffman K, Pathak A, Cooke J, Allen KD. Sociodemographic and Clinical Correlates of Physical Therapy Utilization in Adults With Symptomatic Knee Osteoarthritis. Phys Ther. 2018 Aug 1;98(8):670-678. doi: 10.1093/ptj/pzy052.

  PMID: 29718472 BACKGROUND

• Jimenez DE, Cook B, Bartels SJ, Alegria M. Disparities in mental health service use of racial and ethnic minority elderly adults. J Am Geriatr Soc. 2013 Jan;61(1):18-25. doi: 10.1111/jgs.12063. Epub 2012 Dec 18.

  PMID: 23252464 BACKGROUND

• Jordan JM, Helmick CG, Renner JB, Luta G, Dragomir AD, Woodard J, Fang F, Schwartz TA, Abbate LM, Callahan LF, Kalsbeek WD, Hochberg MC. Prevalence of knee symptoms and radiographic and symptomatic knee osteoarthritis in African Americans and Caucasians: the Johnston County Osteoarthritis Project. J Rheumatol. 2007 Jan;34(1):172-80.

  PMID: 17216685 BACKGROUND

• Kolasinski SL, Neogi T, Hochberg MC, Oatis C, Guyatt G, Block J, Callahan L, Copenhaver C, Dodge C, Felson D, Gellar K, Harvey WF, Hawker G, Herzig E, Kwoh CK, Nelson AE, Samuels J, Scanzello C, White D, Wise B, Altman RD, DiRenzo D, Fontanarosa J, Giradi G, Ishimori M, Misra D, Shah AA, Shmagel AK, Thoma LM, Turgunbaev M, Turner AS, Reston J. 2019 American College of Rheumatology/Arthritis Foundation Guideline for the Management of Osteoarthritis of the Hand, Hip, and Knee. Arthritis Rheumatol. 2020 Feb;72(2):220-233. doi: 10.1002/art.41142. Epub 2020 Jan 6.

  PMID: 31908163 BACKGROUND

• McClendon J, Essien UR, Youk A, Ibrahim SA, Vina E, Kwoh CK, Hausmann LRM. Cumulative Disadvantage and Disparities in Depression and Pain Among Veterans With Osteoarthritis: The Role of Perceived Discrimination. Arthritis Care Res (Hoboken). 2021 Jan;73(1):11-17. doi: 10.1002/acr.24481.

  PMID: 33026710 BACKGROUND

• Vaughn IA, Terry EL, Bartley EJ, Schaefer N, Fillingim RB. Racial-Ethnic Differences in Osteoarthritis Pain and Disability: A Meta-Analysis. J Pain. 2019 Jun;20(6):629-644. doi: 10.1016/j.jpain.2018.11.012. Epub 2018 Dec 10.

  PMID: 30543951 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee; Chronic Pain; Depression; Anxiety Disorders; Motor Activity

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Mental Disorders

Central Study Contacts

Deepak Kumar, PhD,PT

CONTACT

617-358-3037; kumard@bu.edu

Hosea Boakye, MPH, PT

CONTACT

6173588142; hboakye@bu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 2, 2024
• First Posted: July 10, 2024
• Study Start: February 17, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: May 16, 2025

Record last verified: 2025-05

Locations

US (1)