Clinical trial NCT06493903: Positive Minds Strong Joints for Knee Osteoarthritis
Official title: Physical and Mental Health Intervention for Black Adults With Knee Osteoarthritis: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Osteoarthritis, Knee
Keywords: chronic pain
depression
anxiety
exercise
cognitive behavioral therapy
Black adults
Lead sponsor: Boston University Charles River Campus
Sponsor class: OTHER
Collaborators: name: Rheumatology Research Foundation
First posted: 2024-07-10
Enrollment: 40
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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).

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.

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)

Primary outcomes:
measure: Recruitment Rate
timeFrame: Throughout the recruitment process
measure: Retention
timeFrame: From the start of the study to end of the 10 week intervention
measure: Attendance
timeFrame: During 10 weeks intervention period
measure: Satisfaction with treatment
timeFrame: week 10 and week 22
measure: Participant Feedback
timeFrame: week 10 and week 22
Secondary outcomes:
measure: Knee Injury and Osteoarthritis Outcome Score
timeFrame: Baseline, week 5, week 10, week 16 and week 22
measure: Patient Health Questionnaire 9-item
timeFrame: Baseline, week 5, week 10, week 16 and week 22
measure: Generalized anxiety 7-item scale
timeFrame: Baseline, week 5, week 10, week 16 and week 22
measure: Arthritis Self Efficacy Scale
timeFrame: Baseline, week 10, and week 22
measure: Fear Avoidance Beliefs Questionnaire - Physical Activity
timeFrame: Baseline and week 10
measure: Pain Catastrophizing Scale
timeFrame: Baseline and week 10
measure: Trust in Medical Research Questionnaire
timeFrame: Baseline and week 10
measure: Multidimensional Scale of Perceived Social Support
timeFrame: Baseline and week 10
measure: International Physical Activity Questionnaire
timeFrame: Baseline, week 10, week 22
measure: Patient-Reported Outcomes Measurement Information System-sleep
timeFrame: Baseline, week 10
measure: Patient Global Rating of Change
timeFrame: Week 10, Week 22
measure: Numerical Rating Scale-nominated activity
timeFrame: Weekly from start of intervention to week 22
measure: Patient Global Assessment of Osteoarthritis
timeFrame: Weekly start of intervention to week 22
measure: Adherence to exercise
timeFrame: Weekly from start of intervention to week 22
measure: gait speed
timeFrame: Baseline and week 10
measure: Physical Activity Stages of change (short form)
timeFrame: Baseline and week 10
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston University
state: Massachusetts
Study officials:
References:
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