Mindfulness Training for ACL Injury

Overseen By Kristin Haraldsdottir

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Wisconsin, Madison

Disqualifiers: Serious mental illness, Meditation experience, Others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 8 weeks

200 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Healthy Minds Program (HMP) App for ACL injury?

Research shows that mindfulness-based interventions, like those delivered through apps, can help reduce stress and improve mental health in various settings, such as surgical patients with chronic pain and orthopedic surgery residents. These findings suggest that similar mindfulness apps could be beneficial for managing stress and promoting recovery in ACL injury patients. ^{1 2 3 4 5}

Is mindfulness training safe for humans?

Research on mindfulness training, including mobile apps, shows it is generally safe for humans. Participants in various studies reported benefits like reduced stress and improved mental health without significant safety concerns. ^{5 6 7 8 9}

How is the Healthy Minds Program App treatment different from other treatments for ACL injury?

The Healthy Minds Program App is unique because it focuses on mindfulness training to help patients cope with the psychological challenges of ACL injury, unlike traditional treatments that primarily address physical rehabilitation. This app-based approach offers a convenient and accessible way to integrate psychological support into the recovery process. ^{10 11 12 13 14}

Research Team

Andrew Watson, MD, MS

Principal Investigator

University of Wisconsin, Madison

Eligibility Criteria

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.

Inclusion Criteria

I am between 16 and 40 years old.

Exclusion 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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive an 8-week remotely-delivered mindfulness intervention following ACL reconstruction surgery

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at multiple time points

24 months

Assessments at 6 weeks, 3 months, 6 months, 12 months, and 24 months post-surgery

Treatment Details

Interventions

• Healthy Minds Program (HMP) App

Trial Overview 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.

Participant Groups

Group I: Mindfulness Intervention plus Standard of Care Experimental Treatment 1 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 Care Active Control 1 Intervention

Control group receives standard of care only

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials

1,249

Recruited

3,255,000+

Findings from Research

A study involving surgical patients with chronic pain showed that 71% of participants used a mindfulness meditation app at least once during a 6-week period, indicating a strong interest in mindfulness-based interventions (MBIs) for pain management.

Despite the high interest, only 8% of patients adhered to the recommended usage of 10 minutes per day, highlighting the need to identify barriers to compliance in order to effectively implement non-pharmacologic pain management strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence Patterns and Acceptability of a Perioperative, App-Based Mindfulness Meditation Among Surgical Patients With Chronic Pain. Diller, ML., Mascaro, J., Haack, C., et al.[2022]

A brief, 60-second mindfulness video was highly feasible and well-received by all 20 participants in an orthopedic surgical practice, indicating its practicality for busy settings.

Participants experienced significant reductions in pain intensity, state anxiety, and negative emotions like distress and anger after watching the video, suggesting it could be an effective adjunct to traditional pain management strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First Use of a Brief 60-second Mindfulness Exercise in an Orthopedic Surgical Practice; Results from a Pilot Study. Chad-Friedman, E., Talaei-Khoei, M., Ring, D., et al.[2022]

The Toolkit for Optimal Recovery (TOR) is a flexible mind-body intervention designed to help patients transition from acute to chronic pain by addressing psychosocial factors like pain catastrophizing and anxiety.

In a case series of three participants, the TOR intervention led to significant improvements in physical function, pain severity, and psychological outcomes, suggesting it can effectively complement standard orthopedic care for better recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Breaking the Disability Spiral: A Case Series Report Illustrating the Delivery of a Brief Skills Based Coaching Intervention to Prevent Chronic Dysfunction and Pain After Orthopedic Injury. Duarte, BA., Mace, RA., Doorley, JD., et al.[2023]

A mindfulness-based phone application significantly reduced stress, anxiety, and burnout in orthopaedic surgery residents after just 2 months of use, with participants averaging only 8 minutes of use per day, 2 days a week.

The treatment group, which started with higher baseline stress and anxiety, showed notable improvements in emotional exhaustion and depersonalization, indicating that mindfulness techniques may be especially beneficial for those experiencing higher levels of stress.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness Applications: Can They Serve as a Stress, Anxiety, and Burnout Reduction Tool in Orthopaedic Surgery Training? A Randomized Control Trial. Boden, LM., Rodriguez, C., Kelly, JD., et al.[2023]

A mindfulness-based intervention (MBI) program was successfully integrated into routine antenatal care in Sri Lanka, with participants reporting reduced daily stress and improved mental well-being.

Feedback indicated that participants found the MBI culturally appropriate and beneficial, suggesting strong support for its inclusion in the national antenatal care program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of incorporating mindfulness based mental health promotion to the pregnancy care program in Sri Lanka: a pilot study. Agampodi, T., Katumuluwa, S., Pattiyakumbura, T., et al.[2020]

The PHIT for Duty mobile app, designed for military personnel with subclinical psychological issues, received high usability ratings (average score of 4.5 out of 5) and a System Usability Scale score of 85, indicating excellent user satisfaction.

The app effectively integrates mindfulness techniques and health assessments, showing a strong correlation (r = 0.87) with traditional paper forms, suggesting it is a reliable tool for health research in the military context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PHIT for Duty, a Mobile Application for Stress Reduction, Sleep Improvement, and Alcohol Moderation. Kizakevich, PN., Eckhoff, R., Brown, J., et al.[2019]

Mobile mental health apps developed by the National Center for PTSD can improve access to care for individuals with substance use disorders and dual diagnoses, providing valuable support for treatment.

These apps, while not specifically designed for substance use disorders, can enhance self-management and treatment by incorporating key therapeutic elements, although there are limitations and considerations for future development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile Mental Health Apps from the National Center for PTSD: Digital Self-Management Tools for Co-Occurring Disorders. McGee-Vincent, P., Juhasz, K., Jamison, AL., et al.[2021]

The beta test of the Mind Guide mobile health app, involving 16 post-9/11 veterans with PTSD and alcohol use disorder, showed significant reductions in PTSD symptoms and alcohol-related issues, indicating its potential efficacy as an intervention.

The app demonstrated promising effects on related factors such as craving, perceived stress, and emotion regulation, suggesting that mindfulness-based techniques may help veterans manage their conditions effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a mobile mindfulness smartphone app for post-traumatic stress disorder and alcohol use problems for veterans: Beta test results and study protocol for a pilot randomized controlled trial. Davis, JP., Pedersen, ER., Borsari, B., et al.[2023]

A new mindfulness program designed for corrections professionals aims to improve their health and well-being by promoting mindfulness, healthier eating, physical activity, and restorative sleep, with a trial involving 100 participants over 12 weeks.

This innovative program combines technology and e-learning to make mindfulness training more accessible and scalable, potentially leading to widespread use if proven effective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Technology-Enabled Intervention to Enhance Mindfulness, Safety, and Health Promotion Among Corrections Professionals: Protocol for a Prospective Quasi-Experimental Trial. Elliot, D., Kuehl, K., DeFrancesco, C., et al.[2023]

A study involving 69 patients undergoing ACL surgery showed that an interactive cognitive-behavioral multimedia program significantly improved preoperative confidence and reduced postoperative pain and fear of movement compared to standard care.

The multimedia program also enhanced the use and perceived usefulness of educational materials, indicating it could be an effective and cost-efficient way to support patients during ACL surgery and rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Interactive Cognitive-Behavioural Multimedia Program Favourably Affects Pain and Kinesiophobia During Rehabilitation After Anterior Cruciate Ligament Surgery: An Effectiveness Trial. Brewer, BW., Van Raalte, JL., Cornelius, AE.[2023]

Sports physical therapists (PTs) recognize that psychological impairments following an ACL injury can be more significant than physical ones, highlighting the need for better training and resources to address these issues during rehabilitation.

PTs expressed a desire for specific knowledge and interventions focused on psychological aspects of recovery, suggesting that developing psychologically centered rehabilitation programs could enhance patient outcomes after ACL injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychological impairments after ACL injury - Do we know what we are addressing? Experiences from sports physical therapists. Piussi, R., Krupic, F., Senorski, C., et al.[2021]

In the ACL-SPORTS trial, 95% of male athletes returned to sport one year after ACL reconstruction, with 78% returning to their preinjury level, and by two years, all athletes had returned to sport, with 95% at their preinjury level.

The incidence of second ACL injuries was very low, with only one athlete experiencing a second injury, indicating that the training program may effectively reduce the risk of re-injury compared to previous literature.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

TWO YEAR ACL REINJURY RATE OF 2.5%: OUTCOMES REPORT OF THE MEN IN A SECONDARY ACL INJURY PREVENTION PROGRAM (ACL-SPORTS). Arundale, AJH., Capin, JJ., Zarzycki, R., et al.[2022]

A systematic review and meta-analysis of eight studies found that ACL injury prevention training programs can reduce the risk of all ACL injuries by 50% across all athletes.

For female athletes specifically, these programs were even more effective, showing a 67% reduction in the risk of non-contact ACL injuries, highlighting the importance of targeted training for this group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meta-analysis of meta-analyses of anterior cruciate ligament injury reduction training programs. Webster, KE., Hewett, TE.[2019]

A study involving 11 UK student physiotherapists revealed that while they understand the importance of goal setting in ACL rehabilitation, they feel unprepared and have received minimal training on the subject.

Participants expressed a desire for more training in goal setting practices, highlighting a need for improved education in psychological strategies within physiotherapy programs to enhance patient involvement in rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An exploration of UK student physiotherapists' goal setting practices within anterior cruciate ligament rehabilitation. Alexanders, J., Chesterton, P., Brooks, A., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Adherence Patterns and Acceptability of a Perioperative, App-Based Mindfulness Meditation Among Surgical Patients With Chronic Pain. [2022]

2. Iran pubmed.ncbi.nlm.nih.gov

First Use of a Brief 60-second Mindfulness Exercise in an Orthopedic Surgical Practice; Results from a Pilot Study. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Breaking the Disability Spiral: A Case Series Report Illustrating the Delivery of a Brief Skills Based Coaching Intervention to Prevent Chronic Dysfunction and Pain After Orthopedic Injury. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Mindfulness Applications: Can They Serve as a Stress, Anxiety, and Burnout Reduction Tool in Orthopaedic Surgery Training? A Randomized Control Trial. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Feasibility of incorporating mindfulness based mental health promotion to the pregnancy care program in Sri Lanka: a pilot study. [2020]

6. England pubmed.ncbi.nlm.nih.gov

PHIT for Duty, a Mobile Application for Stress Reduction, Sleep Improvement, and Alcohol Moderation. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Mobile Mental Health Apps from the National Center for PTSD: Digital Self-Management Tools for Co-Occurring Disorders. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Development of a mobile mindfulness smartphone app for post-traumatic stress disorder and alcohol use problems for veterans: Beta test results and study protocol for a pilot randomized controlled trial. [2023]

9. Canada pubmed.ncbi.nlm.nih.gov

Technology-Enabled Intervention to Enhance Mindfulness, Safety, and Health Promotion Among Corrections Professionals: Protocol for a Prospective Quasi-Experimental Trial. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

An Interactive Cognitive-Behavioural Multimedia Program Favourably Affects Pain and Kinesiophobia During Rehabilitation After Anterior Cruciate Ligament Surgery: An Effectiveness Trial. [2023]

11. Denmark pubmed.ncbi.nlm.nih.gov

Psychological impairments after ACL injury - Do we know what we are addressing? Experiences from sports physical therapists. [2021]

12. United States pubmed.ncbi.nlm.nih.gov

TWO YEAR ACL REINJURY RATE OF 2.5%: OUTCOMES REPORT OF THE MEN IN A SECONDARY ACL INJURY PREVENTION PROGRAM (ACL-SPORTS). [2022]

13. United States pubmed.ncbi.nlm.nih.gov

Meta-analysis of meta-analyses of anterior cruciate ligament injury reduction training programs. [2019]

14. England pubmed.ncbi.nlm.nih.gov

An exploration of UK student physiotherapists' goal setting practices within anterior cruciate ligament rehabilitation. [2022]