Healthy Minds Program (HMP) App for ACL Injury

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Wisconsin, Madison, WI
ACL Injury+2 More
Healthy Minds Program (HMP) App - Behavioral
Eligibility
18 - 65
All Sexes
What conditions do you have?
Select

Study Summary

Anterior cruciate ligament (ACL) surgery patients experience physical trauma, both in the physical injury itself and following surgery, and face potential long-lasting adverse effects such as muscle weakness, diminished joint function, hip pain, and fear. Many of these patients report more significant anxiety and depression following surgery, which can further compound these patients' adverse outcomes. This study is a single-blind, randomized controlled trial design to evaluate the effects of a remotely-delivered 8-week mindfulness intervention on patient-reported outcomes (PROs) following ACL reconstruction surgery.

Eligible Conditions

  • ACL Injury
  • ACL

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

11 Primary · 10 Secondary · Reporting Duration: 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery

Month 24
Change in Hop Height
Change in Jump Height
Change in Jump Landing Assessment: Force Measures
Change in Vertical Hop Testing: Force Measures
Hamstring to Quadriceps Torque Ratio
Knee Range of Motion
Peak Torque
Peak Torque Relative to Body Weight
Month 24
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
Change in Horowitz Impact of Events Scale Score
Change in International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form Score
Change in PROMIS Anxiety Questionnaire Score
Change in PROMIS Depression Questionnaire Score
Change in PROMIS Global Health Questionnaire (GHQ) Score
Change in Pain Catastrophizing Scale (PCS) Score
Change in Single Assessment Numeric Evaluation (SANE) Score
Change in Tampa Scale of Kinesiophobia 11 (TSK-11) Score
up to 24 months
Number of Participants Who Return to Sport
Total Duration of Mindfulness Intervention in the Mindfulness Group

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Standard of Care
1 of 2
Mindfulness Intervention plus Standard of Care
1 of 2
Active Control
Experimental Treatment

200 Total Participants · 2 Treatment Groups

Primary Treatment: Healthy Minds Program (HMP) App · No Placebo Group · N/A

Mindfulness Intervention plus Standard of Care
Behavioral
Experimental Group · 1 Intervention: Healthy Minds Program (HMP) App · Intervention Types: Behavioral
Standard of CareNoIntervention Group · 1 Intervention: Standard of Care · Intervention Types:

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
Closest Location: University of Wisconsin · Madison, WI
Photo of wi university of wisconsin 1Photo of madison 2Photo of madison 3
2003First Recorded Clinical Trial
1 TrialsResearching ACL Injury
383 CompletedClinical Trials

Who is running the clinical trial?

University of Wisconsin, MadisonLead Sponsor
1,052 Previous Clinical Trials
2,559,711 Total Patients Enrolled
Andrew Watson, MD, MSPrincipal InvestigatorUniversity of Wisconsin, Madison
1 Previous Clinical Trials
200 Total Patients Enrolled

Eligibility Criteria

Age 18 - 65 · All Participants · 3 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have regular access to a mobile device compatible with the HMP App (Android or iOS).

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.