Positive Minds Strong Joints for Knee Osteoarthritis

Official title

Physical and Mental Health Intervention for Black Adults With Knee Osteoarthritis: A Feasibility Study

Overview

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.

Interventions

• Behavioral Positive Minds, Strong Joints
  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.

Primary outcome measures

• Recruitment Rate [Time frame: Throughout the recruitment process]
• Retention [Time frame: From the start of the study to end of the 10 week intervention]
• Attendance [Time frame: During 10 weeks intervention period]
• Satisfaction with treatment [Time frame: week 10 and week 22]
• Participant Feedback [Time frame: week 10 and week 22]

Secondary outcome measures (12)

• Knee Injury and Osteoarthritis Outcome Score [Time frame: Baseline, week 5, week 10, week 16 and week 22]
• Patient Health Questionnaire 9-item [Time frame: Baseline, week 5, week 10, week 16 and week 22]
• Generalized anxiety 7-item scale [Time frame: Baseline, week 5, week 10, week 16 and week 22]
• Arthritis Self Efficacy Scale [Time frame: Baseline, week 10, and week 22]
• Fear Avoidance Beliefs Questionnaire - Physical Activity [Time frame: Baseline and week 10]
• Pain Catastrophizing Scale [Time frame: Baseline and week 10]
• Trust in Medical Research Questionnaire [Time frame: Baseline and week 10]
• Multidimensional Scale of Perceived Social Support [Time frame: Baseline and week 10]
• International Physical Activity Questionnaire [Time frame: Baseline, week 10, week 22]
• Patient-Reported Outcomes Measurement Information System-sleep [Time frame: Baseline, week 10]
• Patient Global Rating of Change [Time frame: Week 10, Week 22]
• Numerical Rating Scale-nominated activity [Time frame: Weekly from start of intervention to week 22]

Eligibility 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• Boston University — Boston

Publications

• 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):1578-1 PMID 31278997
• 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
• 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
• 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
• 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
• 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 Founda PMID 31908163
• 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
• 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

Identifiers

NCT: NCT06493903 · 7517

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗