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NCT Number: NCT06493903

Positive Minds Strong Joints for Knee Osteoarthritis

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).

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boston University

Boston, Massachusetts, 02215, United States

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. Recruitment Rate

    Time frame: Throughout the recruitment process

    Number of participants enrolled out of those screened

  2. Retention

    Time frame: From the start of the study to end of the 10 week intervention

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

  3. Attendance

    Time frame: During 10 weeks intervention period

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

  4. Satisfaction with treatment

    Time frame: week 10 and week 22

    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.

  5. Participant Feedback

    Time frame: week 10 and week 22

    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.

Secondary outcomes

  1. Knee Injury and Osteoarthritis Outcome Score

    Time frame: Baseline, week 5, week 10, week 16 and week 22

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

  2. Patient Health Questionnaire 9-item

    Time frame: Baseline, week 5, week 10, week 16 and week 22

    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

  3. Generalized anxiety 7-item scale

    Time frame: Baseline, week 5, week 10, week 16 and week 22

    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

  4. Arthritis Self Efficacy Scale

    Time frame: Baseline, week 10, and week 22

    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.

  5. Fear Avoidance Beliefs Questionnaire - Physical Activity

    Time frame: Baseline and week 10

    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

  6. Pain Catastrophizing Scale

    Time frame: Baseline and week 10

    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.

  7. Trust in Medical Research Questionnaire

    Time frame: Baseline and week 10

    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

  8. Multidimensional Scale of Perceived Social Support

    Time frame: Baseline and week 10

    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.

  9. International Physical Activity Questionnaire

    Time frame: Baseline, week 10, week 22

    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

  10. Patient-Reported Outcomes Measurement Information System-sleep

    Time frame: Baseline, week 10

    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.

  11. Patient Global Rating of Change

    Time frame: Week 10, Week 22

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

  12. Numerical Rating Scale-nominated activity

    Time frame: Weekly from start of intervention to week 22

    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

  13. Patient Global Assessment of Osteoarthritis

    Time frame: Weekly start of intervention to week 22

    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.

  14. Adherence to exercise

    Time frame: Weekly from start of intervention to week 22

    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

  15. gait speed

    Time frame: Baseline and week 10

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

  16. Physical Activity Stages of change (short form)

    Time frame: Baseline and week 10

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

Study contacts

Contact information is provided by the study sponsor or research team.

Deepak Kumar, PhD,PT

CONTACT

[email protected]

617-358-3037

Hosea Boakye, MPH, PT

CONTACT

[email protected]

6173588142

Sponsors and collaborators

Lead sponsor

Boston University Charles River Campus

Other

Collaborators

  • Rheumatology Research Foundation

Registry information

Official study title

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

Acronym: PMSJ

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 10, 2024
Registry last updated
May 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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