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Mindfulness-Based Intervention
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
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
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 moreSecondary study objectives
Change in Jump Landing Assessment: Force Measures
Change in Vertical Hop Testing: Force Measures
Hamstring to Quadriceps Torque Ratio
+2 moreTrial 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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Who is running the clinical trial?
University of Wisconsin, MadisonLead Sponsor
1,210 Previous Clinical Trials
3,157,539 Total Patients Enrolled
Andrew Watson, MD, MSPrincipal InvestigatorUniversity of Wisconsin, Madison
1 Previous Clinical Trials
200 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have practiced meditation or mindfulness for over 30 minutes a month in the last year.I have had ACL surgery on the opposite knee before.I need surgery to repair multiple ligaments in my knee.I am between 16 and 40 years old.I have had surgery on the same knee before.I am between 18 and 40 years old.I am scheduled for ACL surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Mindfulness Intervention plus Standard of Care
- Group 2: Standard of Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Anterior Cruciate Ligament (ACL) Patient Testimony for trial: Trial Name: NCT05542563 — N/A
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