Positive Minds Strong Joints for Knee Osteoarthritis (PMSJ)

August 9, 2026 updated by: Boston University Charles River Campus

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
39

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Deepak Kumar, PhD,PT
  • Phone Number: 617-358-3037
  • Email: kumard@bu.edu

Study Contact Backup

  • Name: Hosea Boakye, MPH, PT
  • Phone Number: 6173588142
  • Email: hboakye@bu.edu

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Boston University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Positive Minds Strong Joints
Participants 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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Recruitment Rate
Time Frame: Throughout the recruitment process
Number of participants enrolled out of those screened
Throughout the recruitment process
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
From the start of the study to end of the 10 week intervention
Attendance
Time Frame: During 10 weeks intervention period
Proportion of participants that attended at least 80% of intervention sessions
During 10 weeks intervention period
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.
week 10 and week 22
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.
week 10 and week 22

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
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
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
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
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
Baseline, week 5, week 10, week 16 and week 22
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.
Baseline, week 10, and week 22
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
Baseline and week 10
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.
Baseline and week 10
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
Baseline and week 10
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.
Baseline and week 10
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
Baseline, week 10, week 22
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.
Baseline, week 10
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.
Week 10, Week 22
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
Weekly from start of intervention to week 22
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.
Weekly start of intervention to week 22
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
Weekly from start of intervention to week 22
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
Baseline and week 10
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.
Baseline and week 10

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boston University Charles River Campus

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Rheumatology Research Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Deepak Kumar, PhD,PT, Boston University Charles River Campus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 17, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 25, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 2, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 9, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 10, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 11, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 7517
  • 9550306371 (Other Grant/Funding Number: Rheumatology Research Foundation)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Requests will be considered on an individual basis

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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