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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

Study 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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
Change in Hop Height
Change in Jump Height
Change in Jump Landing Assessment: Force Measures
+7 more

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

Find a Location

Who is running the clinical trial?

University of Wisconsin, MadisonLead Sponsor
1,189 Previous Clinical Trials
3,169,346 Total Patients Enrolled
Andrew Watson, MD, MSPrincipal InvestigatorUniversity of Wisconsin, Madison
1 Previous Clinical Trials
200 Total Patients Enrolled

Media Library

Healthy Minds Program (HMP) App (Mindfulness-Based Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05542563 — N/A
Anterior Cruciate Ligament (ACL) Research Study Groups: Mindfulness Intervention plus Standard of Care, Standard of Care
Anterior Cruciate Ligament (ACL) Clinical Trial 2023: Healthy Minds Program (HMP) App Highlights & Side Effects. Trial Name: NCT05542563 — N/A
Healthy Minds Program (HMP) App (Mindfulness-Based Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05542563 — N/A
Anterior Cruciate Ligament (ACL) Patient Testimony for trial: Trial Name: NCT05542563 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research experiment currently recruiting participants?

"Affirmative, the information on clinicaltrials.gov suggests that this research endeavour is still recruiting patients. This trial was initially made public on July 1st 2022 and has been edited for accuracy most recently on September 12th 2022. Thus far, 200 participants have been accepted at a single medical centre."

Answered by AI

Is it feasible for me to take part in this clinical experiment?

"This study is seeking 200 participants aged 18 to 30 with an anterior cruciate ligament (ACL) injury. Other prerequisites include being under the age of 30 at the time of their pre-surgery visit, having undergone ACL surgery, and possessing a mobile device that supports Healthy Minds Program's (HMP) app for Android or iOS operating systems."

Answered by AI

Does this clinical experiment accommodate participants aged 45 or above?

"As outlined in the trial's entry criteria, individuals aged between 18 and 30 years are eligible to participate."

Answered by AI

What is the current size of the cohort participating in this clinical trial?

"Affirmative. Clinicaltrials.gov holds records that this medical trial is looking for volunteers, with the first post being on July 1st 2022 and last updated September 12th 2022. The research team aims to find 200 participants from just one site."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I need help with my medical needs. Good advice leading to even better tresults.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Mindfulness and ACL Surgery
2022. "Mindfulness and ACL Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05542563.
All > Mindfulness
~67 spots leftby Apr 2025
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