Positive Minds Strong Joints for Knee Osteoarthritis

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 50 Years and Over
Gender All
More Inclusion & Exclusion 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.
  • - Available to attend in-person intervention sessions at the community location.
  • - 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)

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06493903
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Boston University Charles River Campus
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Osteoarthritis, Knee
Additional Details

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.

Arms & Interventions

Arms

Experimental: Positive Minds Strong Joints

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.

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Boston University, Boston, Massachusetts

Status

Recruiting

Address

Boston University

Boston, Massachusetts, 02215