Mindfulness Training for ACL Injury

N/A

Recruiting

Led By Andrew Watson, MD, MS

Research Sponsored by University of Wisconsin, Madison

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery

Awards & highlights

No Placebo-Only Group

Summary

This trial found that a mindfulness intervention can help reduce anxiety and depression in ACL surgery patients, and improve their overall patient-reported outcomes.

Who is the study for?

This trial is for individuals aged 18-40 who are about to have ACL surgery and regularly use a mobile device. They must not have serious mental illnesses, significant prior mindfulness practice, other major knee injuries requiring complex surgery, or previous surgeries on the same or opposite ACL.

What is being tested?

The study tests if using the Healthy Minds Program (HMP) App for an 8-week mindfulness intervention can improve patient-reported outcomes after ACL reconstruction. It's a single-blind trial where patients don't know if they're getting the real treatment but researchers do.

What are the potential side effects?

Since this trial involves a mindfulness app rather than medication, traditional side effects aren't expected. However, participants may experience emotional discomfort as they engage with their thoughts and feelings during mindfulness practices.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 weeks, 3 months, 6 months, 12 months, 24 months post surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Anterior Cruciate Ligament Return to Sport After Injury scale (ACL-RSI) Score

Change in Athletic Identity Measurement Scale (AIMS) Score

Change in General physical activity questionnaire (GPAQ) Measured as Minutes of Total Physical Activity per day

+8 more

Secondary study objectives

Change in Jump Landing Assessment: Force Measures

Change in Vertical Hop Testing: Force Measures

Hamstring to Quadriceps Torque Ratio

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Mindfulness Intervention plus Standard of CareExperimental Treatment1 Intervention

The Foundations and Awareness modules of the HMP app require a minimum of 133 and 253 minutes, equating to less than 5 and less than 10 minutes per day on average, respectively. Date, duration, and content of usage will be recorded for each participant through the app. Participants will have access to the entire contents of the app for the full duration of the study.

Group II: Standard of CareActive Control1 Intervention

Control group receives standard of care only

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