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Osteoarthritis, KneePMSJNCT06493903

Positive Minds Strong Joints for Knee Osteoarthritis

A study testing Positive Minds, Strong Joints in people with Osteoarthritis, Knee, run by Boston University Charles River Campus at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Osteoarthritis, Knee
What is being tested?
Positive Minds, Strong Joints
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
1 siteUnited States
Study dates
17 Feb 2025to 30 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 17Show fewer
  • 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)

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Boston University

    Boston, Massachusetts, 02215

Other trials in United States

About this study

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

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).

Read the 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.

Being tested
Positive Minds, Strong Joints
Keywords
chronic pain, depression, anxiety, exercise, cognitive behavioral therapy, Black adults
Medical subject headings
Osteoarthritis, Knee, Chronic Pain, Depression, Anxiety Disorders, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Positive Minds, Strong JointsBehavioural

    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.

Study groups in NCT06493903
Study groupRoleWhat they receive
Positive Minds Strong JointsExperimentalParticipants will receive an individual mental health intervention and a group-based exercise intervention through a HIPPAA-Protected Zoom videoconferencing once a week for 10 weeks.
Receives: Behavioral: Positive Minds, Strong Joints

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recruitment Rate

    Number of participants enrolled out of those screened

    Measured: Throughout the recruitment process

  2. Retention

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

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

  3. Attendance

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

    Measured: During 10 weeks intervention period

  4. 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.

    Measured: week 10 and week 22

  5. 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.

    Measured: week 10 and week 22

Secondary outcomes (16)
  1. Knee Injury and Osteoarthritis Outcome Score

    Patient-reported outcome for knee pain and disability; a score from 0 to 100, 0 representing extreme problems and 100 representing no problems.

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

  2. Patient Health Questionnaire 9-item

    9-item questionnaire assessing depression symptoms. Each question is scored from 0 to 3 where higher scores indicate higher frequency of experiencing depressive symptoms. Total score is the sum of individual item scores. Score range is 0-27. Higher total scores indicate greater severity of depression

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

  3. Generalized anxiety 7-item scale

    It assesses anxiety symptoms. Each question is scored from 0 to 3 and the sum value of individual questions is the total score with range form 0-21. Higher total scores indicate greater severity of anxiety

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

  4. Arthritis Self Efficacy Scale

    It measures confidence in one's capacity to function despite pain. Scores range from 1 (very uncertain) to 10 (very certain). It has three subscales of pain, function, and other symptoms calculated as average of items contributing to that subscale. Higher scores indicate greater self-efficacy to manage osteoarthritis.

    Measured: Baseline, week 10, and week 22

  5. Fear Avoidance Beliefs Questionnaire - Physical Activity

    4-item questionnaire to determine how one's fear avoidance beliefs contributes to the cognitive/affective part of their knee pain. Each item is scored from 0 to 6. Total scores are summation of each item scores. Range is 0-24. Higher total scores indicate greater fear of physical activity

    Measured: Baseline and week 10

  6. Pain Catastrophizing Scale

    Questionnaire for a person's thought and feeling about pain. The questionnaire has 3 subscales namely rumination, magnification and helplessness. Each question is rated on a 5-point scale, from 0 (not at all) to 4 (always). It is scored by summing the ratings of its 13 items with a range of 0-52. Higher scores indicate greater pain catastrophizing tendencies in response to pain.

    Measured: Baseline and week 10

  7. Trust in Medical Research Questionnaire

    It assesses participants' trust in medical research. It includes items related to confidence in researchers, and the scientific process, rated on a 5 Likert scale (strongly disagree, disagree, neutral, agree and strongly agree) with a total score range of 0-48. Higher scores indicate greater trust in medical research

    Measured: Baseline and week 10

  8. Multidimensional Scale of Perceived Social Support

    It measures perceived social support from family, friends, and significant others. It consists of 12 items rated on a 7- Likert scale for a total score range from 12-84. Higher scores indicate greater perceived social support across various domains.

    Measured: Baseline and week 10

  9. International Physical Activity Questionnaire

    It assesses physical activity levels across diverse populations. The responses are converted into MET (Metabolic Equivalent of Task) minutes per week. The results can be continuous or categorized. For the categorized results, individuals' physical activity categorized as low, moderate and high

    Measured: Baseline, week 10, week 22

  10. Patient-Reported Outcomes Measurement Information System-sleep

    It is used to measure measures perceived sleep quality, difficulty in sleep and having enough and refreshing sleep. The 8 questions are rated on a 5-point scale. The scores are summed together with a raw score of from 8 to 40. The raw scores are then converted to standardized T-scores using conversion tables.

    Measured: Baseline, week 10

  11. Patient Global Rating of Change

    This is a single item questionnaire with 15 options ranging from a very great deal worse to a very great deal better.

    Measured: Week 10, Week 22

  12. Numerical Rating Scale-nominated activity

    average rating of knee pain from 0-10, where 0 represents no pain and 10 represents worst pain imaginable, in the past week in a nominated activity selected at baseline

    Measured: Weekly from start of intervention to week 22

  13. Patient Global Assessment of Osteoarthritis

    It assesses participant's assessment of impact of osteoarthritis on their general health on a 0-100 scale. 0 is very poor and 100 is very well.

    Measured: Weekly start of intervention to week 22

  14. Adherence to exercise

    This questionnaire is used to assess participants adhere to exercise. Participants document their engagement in unsupervised exercise throughout the week by noting minutes of exercise per day of the week

    Measured: Weekly from start of intervention to week 22

  15. gait speed

    A known distance of20-28 meters divided by time taken to walk this distance in m/s

    Measured: Baseline and week 10

  16. Physical Activity Stages of change (short form)

    It assesses participants readiness to engage physical activity. It consists of five stages which include Precontemplation, contemplation, preparation, action and maintenance.

    Measured: Baseline and week 10

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jul 2024
  2. Study start17 Feb 2025
  3. Primary completion25 May 2026
  4. Study completion30 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06493903
Sponsor's protocol ID
7517
Other IDs
9550306371
Acronym
PMSJ
Status last verified
Aug 2026
First submitted
2 Jul 2024
Last updated
11 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Requests will be considered on an individual basis

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):1578-1589. doi: 10.1016/j.joca.2019.06.011. Epub 2019 Jul 3.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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 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.

    PubMed 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.

    PubMed 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.

    PubMed 30543951

Questions about this trial

What is this clinical trial studying?

A study testing Positive Minds, Strong Joints in people with Osteoarthritis, Knee, run by Boston University Charles River Campus at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recruitment Rate (time frame: Throughout the recruitment process). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06493903, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.

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