Graded Exposure + Mindfulness for ACL Injury

Recruiting at 1 trial location

Overseen By Shelby E Baez, Ph.D., ATC

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of North Carolina, Chapel Hill

Disqualifiers: Secondary ACL injury, others

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 20

Duration: 5 weeks

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether combining graded exposure (gradually facing fears) and mindfulness meditation can reduce fear and anxiety about re-injuring the knee after ACL reconstruction surgery. It also examines if these methods improve the speed of leg reactions compared to those who wait without treatment. Individuals who injured their knee playing sports and have lingering fears about re-injury, especially if 1 to 5 years have passed since their ACL surgery, might be suitable for this trial. Participants will either engage in mindfulness exercises and exposure therapy or remain on a waitlist for a set period. As an unphased trial, this study provides a unique opportunity to explore innovative approaches to overcoming fear and anxiety post-surgery.

Do I need to stop my current medications for this trial?

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

What prior data suggests that graded exposure and mindfulness meditation are safe for ACL injury rehabilitation?

Research has shown that graded exposure and mindfulness meditation are generally safe and well-tolerated. These methods use psychological techniques to help manage anxiety and improve mental health. No reports of serious side effects have emerged from these practices. Participants in past studies found that these methods reduced anxiety and fear without causing harm. This suggests they are a safe option for people recovering from ACL surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Graded Exposure + Mindfulness Meditation (GEMM) approach for ACL injuries because it combines psychological and mindfulness techniques to target recovery uniquely. Unlike traditional treatments like physical therapy and surgery, GEMM uses graded exposure to tackle the fear and anxiety often associated with returning to physical activity. Additionally, integrating mindfulness meditation helps enhance mental resilience and focus during rehabilitation. This holistic approach could potentially speed up recovery and improve overall outcomes for athletes and active individuals.

What evidence suggests that this trial's treatments could be effective for ACL injury?

This trial will compare Graded Exposure and Mindfulness Meditation (GEMM) with a Waitlist Control group. Research has shown that gradually facing fears and practicing mindfulness meditation can aid recovery after ACL surgery. Gradually facing fears involves slowly acclimating to situations that might cause worry, reducing anxiety about re-injury. Mindfulness meditation helps individuals focus on the present moment, further lowering anxiety. Studies indicate that combining these methods can improve mental health and increase readiness to return to sports. Evidence also suggests they can enhance leg reaction times, crucial for athletes. Overall, promising evidence supports this combination in improving recovery from ACL surgery. ^{1 2 3 4 5}

Who Is on the Research Team?

Shelby E Baez, Ph.D., ATC

Principal Investigator

UNC-Chapel Hill

Are You a Good Fit for This Trial?

This trial is for young adults aged 18-25 who had ACL reconstruction surgery 1 to 5 years ago due to a sports-related injury and are experiencing fear related to their injury. It's not for those with multiple ACL injuries, additional surgeries at the time of their ACL repair, or without high levels of injury-related fear.

Inclusion Criteria

Injured their knee playing or training for sports (recreational or organized)

I had ACL reconstruction surgery between 1 and 5 years ago.

Have self-reported levels of fear on the Tampa Scale of Kinesiophobia-11 and the Photographic Series of Sports Activities for ACLR

Exclusion Criteria

Do not exhibit elevated injury-related fear

History of secondary ACL injury

I am having other surgeries along with my ACL repair.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo 5 weeks of Graded Exposure and Mindfulness Meditation (GEMM) or are placed in a waitlist control group

5 weeks

20 sessions (virtual) for GEMM group

Follow-up

Participants are monitored for changes in injury-related fear, reinjury anxiety, and reaction time post-treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Graded Exposure and Mindfulness Meditation
• Waitlist Control

Trial Overview

The study tests if graded exposure therapy combined with mindfulness meditation can reduce fear and anxiety about reinjury and improve reaction times in the lower extremity compared to a group that receives no immediate treatment (waitlist control).

How Is the Trial Designed?

Group I: Graded Exposure and Mindfulness Meditation Experimental Treatment 1 Intervention

The participants randomized to the GEMM group will complete 1) written exposure and 2) in vivo exposure and will be asked to rate their task specific fears after baseline tests. Tasks identified to be fearful will be used to develop the graded-hierarchy of fearful situations, and these fearful situations will be addressed in the GEMM. Participants will be instructed to watch a 30-min video that provides education on the rationale of cognitive behavioral therapies, specifically the benefits of exposure therapy and mindfulness meditation. Participants randomized into the GEMM group will also complete 5-weeks of Mobile Mindfulness Meditation. Participants randomized into the GEMM group will be guided through 4, 10-minute Mobile Mindfulness Meditation per week (20 total sessions) via the Headspace mobile application where they will learn the fundamentals of mindfulness meditation and how to apply mindfulness meditation to sports rehabilitation.

Group II: Waitlist Control Placebo Group 1 Intervention

Participants will be randomized to a waitlist control group. Participants will receive an email stating that they will receive access to 5-weeks of Headspace after 5-weeks. Participants will be also asked to not change their normal routines or download apps for relaxation, meditation, or sleep during 5-weeks. After completion of the outcome assessments at 5-weeks, participants in this group will receive access to 5-weeks of Headspace.

Graded Exposure and Mindfulness Meditation is already approved in United States for the following indications:

Approved in United States as Graded Exposure and Mindfulness Meditation for:

• Anxiety reduction
• Injury-related fear management
• Reinjury anxiety management
• Lower extremity reaction time improvement

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

National Athletic Trainers' Association Research & Education Foundation (NATA Foundation)

Collaborator

Trials

7

Recruited

560+

Published Research Related to This Trial

A study involving 168 young male elite soccer players showed that a mindfulness-based program significantly reduced the incidence of sports injuries compared to a control group that received presentations on sport-injury psychology.

The mindfulness training improved participants' mindfulness and attention control while reducing sport anxiety and stress, suggesting that these psychological factors are linked to injury risk in young athletes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of a Mindfulness-Based Program on the Incidence of Injuries in Young Male Soccer Players. Naderi, A., Shaabani, F., Gharayagh Zandi, H., et al.[2023]

Mindfulness interventions in patients with upper-extremity conditions showed a positive association with reduced pain, improved mood, and better functional outcomes, based on a systematic review of four studies involving 335 patients.

The effects of mindfulness on pain reduction were noted, although the improvement was below the minimal clinically important difference, indicating that while beneficial, the impact may not be substantial enough for all patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness in Patients with Upper-Extremity Conditions: A Summary of Existing Literature. Kootstra, TJM., Smeeing, DPJ., Beks, RB., et al.[2021]

In a study of 125 patients with acute ACL injuries, knee laxity increased slightly over the first year after non-surgical treatment, but the average change was less than 1 mm, raising questions about its clinical significance.

Knee laxity was weakly correlated with self-reported knee function and perceived stability during rehabilitation, suggesting that while laxity changes occur, they may not strongly impact overall recovery or confidence in knee stability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bilateral changes in knee joint laxity during the first year after non-surgically treated anterior cruciate ligament injury. Sonesson, S., Kvist, J.[2022]

In a study involving 127 participants undergoing total joint arthroplasty, those who completed an eight-week Mindfulness-Based Stress Reduction (MBSR) program reported significantly greater improvements in knee pain and physical function at 12 months post-surgery compared to those receiving usual care.

The MBSR group experienced a mean reduction in knee pain of 10.3 points and improved function by 10.2 points on the WOMAC scale, indicating that MBSR can be an effective intervention for enhancing recovery in patients with psychological distress.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of mindfulness training prior to total joint arthroplasty on post-operative pain and physical function: A randomised controlled trial. Dowsey, M., Castle, D., Knowles, S., et al.[2020]

Mindfulness meditation enhances well-being and reduces psychiatric symptoms by improving attention regulation, body awareness, emotion regulation, and changing self-perspective, as supported by recent empirical research.

Neuroscientific studies indicate that mindfulness practice leads to neuroplastic changes in key brain areas, suggesting that these mechanisms work together to improve self-regulation and could inform future treatments for psychological disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How Does Mindfulness Meditation Work? Proposing Mechanisms of Action From a Conceptual and Neural Perspective. Hölzel, BK., Lazar, SW., Gard, T., et al.[2022]

Mindfulness meditation, particularly through programs like Mindfulness-Based Stress Reduction (MBSR) and Mindfulness-Based Cognitive Therapy (MBCT), is widely used to treat various conditions such as stress, depression, and chronic pain, but concerns about its safety have emerged due to reported adverse events.

The viewpoint argues that many reported negative experiences during mindfulness meditation, such as anxiety or discomfort, are not true adverse events but rather expected reactions that can occur as individuals learn to manage their mental and physical states; severe outcomes like psychosis are often influenced by external factors rather than the meditation itself.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What Are Adverse Events in Mindfulness Meditation? Binda, DD., Greco, CM., Morone, NE.[2022]

Mindfulness-based interventions (MBIs) were found to be more effective than passive controls in most cases, based on a systematic review of 44 meta-analyses involving 30,483 participants across 336 randomized controlled trials.

While MBIs showed similar or superior efficacy compared to specific active controls and evidence-based treatments, their effects were generally smaller and less statistically significant when compared to active controls, indicating a need for further research to strengthen the evidence base.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Empirical Status of Mindfulness-Based Interventions: A Systematic Review of 44 Meta-Analyses of Randomized Controlled Trials. Goldberg, SB., Riordan, KM., Sun, S., et al.[2022]

Mindfulness training significantly reduces anxiety symptoms in adults with generalized anxiety disorder (GAD), showing a large effect size compared to inactive controls, based on a meta-analysis of four studies involving 334 participants.

While mindfulness training did not show significant advantages over active controls, changes in trait mindfulness were found to mediate anxiety reduction, suggesting different mechanisms at play compared to traditional cognitive therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychological Outcomes and Mechanisms of Mindfulness-Based Training for Generalised Anxiety Disorder: A Systematic Review and Meta-Analysis. Williams, M., Honan, C., Skromanis, S., et al.[2023]

In a study involving 69 participants with high psychological distress, an eight-week mindfulness intervention significantly reduced anxiety sensitivity, which in turn mediated improvements in anxiety and depression severity.

The results suggest that anxiety sensitivity may be a key mechanism through which mindfulness training alleviates symptoms of anxiety and depression, highlighting the importance of understanding how mindfulness works.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The potential mediating role of anxiety sensitivity in the impact of mindfulness training on anxiety and depression severity and impairment: A randomized controlled trial. Xie, Q., Guan, Y., Hofmann, SG., et al.[2023]

In a 21-day mindfulness-based intervention with 82 participants, 87% reported at least one momentary adverse effect during meditation, primarily anxiety, indicating that mindfulness practice can sometimes lead to temporary increases in anxiety.

Despite these momentary effects, 25% of participants experienced sustained adverse effects in daily life after the intervention, but these were not linked to the momentary effects during meditation, suggesting that increased awareness of internal states may contribute to these post-intervention challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First, do no harm: An intensive experience sampling study of adverse effects to mindfulness training. Aizik-Reebs, A., Shoham, A., Bernstein, A.[2021]

The Mindfulness for Pain and Performance Enhancement (MPPE) program, based on Acceptance and Commitment Therapy, significantly improved pain reduction and other psychological measures among US Navy recruits, with effect sizes ranging from small to large, indicating its efficacy in aiding recovery from injuries.

Recruits who completed the MPPE program had a higher graduation rate (58.3%) compared to those who did not participate (45.5%), suggesting that this intervention could be beneficial in reducing attrition rates and enhancing overall performance in boot camp.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Acceptance and Commitment Therapy in Increasing Resilience and Reducing Attrition of Injured US Navy Recruits. Udell, CJ., Ruddy, JL., Procento, PM.[2019]

The study found that a guided imagery intervention, when combined with standard rehabilitation, significantly improved knee laxity in patients six months after anterior cruciate ligament repair, compared to standard rehabilitation alone.

While the imagery intervention did not show a difference in knee strength or self-efficacy, it positively influenced neurohormonal factors like noradrenaline and dopamine, suggesting potential mechanisms for enhanced recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Guided imagery to improve functional outcomes post-anterior cruciate ligament repair: randomized-controlled pilot trial. Maddison, R., Prapavessis, H., Clatworthy, M., et al.[2022]

Differential learning strategies and external focus of attention significantly reduced risk factors for anterior cruciate ligament (ACL) injury in athletes, as shown in a study involving 48 male athletes over eight weeks.

The differential learning group exhibited larger effect sizes in improving kinetic and kinematic variables related to ACL injury risk compared to other methods, suggesting that varied movement practices may be more effective in injury prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing the Effects of Differential Learning, Self-Controlled Feedback, and External Focus of Attention Training on Biomechanical Risk Factors of Anterior Cruciate Ligament (ACL) in Athletes: A Randomized Controlled Trial. Ghanati, HA., Letafatkar, A., Shojaedin, S., et al.[2022]

Mindfulness training helps individuals become more aware of their daily experiences, which is linked to reduced symptoms of psychological issues and increased well-being.

The benefits of mindfulness are thought to arise from improved self-focused attention, which decreases rumination and emotional avoidance, leading to better self-regulation and overall psychological functioning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-focused attention and mechanisms of change in mindfulness-based treatment. Baer, RA.[2022]

Citations

1.

trialx.com

trialx.com/clinical-trials/listings/303291/graded-exposure-and-mindfulness-meditation-for-patients-post-acl-reconstruction/

Graded Exposure and Mindfulness Meditation for Patients ...

Clinical trial for Anterior Cruciate Ligament Injuries , Graded Exposure and Mindfulness Meditation for Patients Post-ACL Reconstruction.

2.

ctv.veeva.com

ctv.veeva.com/study/graded-exposure-and-mindfulness-meditation-for-patients-post-acl-reconstruction

Graded Exposure and Mindfulness Meditation for Patients ...

The investigators will determine the effect of graded exposure and mindfulness meditation to 1) decrease self-reported injury-related fear and reinjury anxiety.

3.

withpower.com

withpower.com/trial/phase-anterior-cruciate-ligament-injuries-7-2023-c4d7e

Graded Exposure + Mindfulness for ACL Injury

This trial tests if gradually facing fears and practicing mindfulness can reduce anxiety and improve reaction times in patients who had ACL surgery.

4.

researchforme.unc.edu

researchforme.unc.edu/study-details?rcid=4904

Graded Exposure and Mindfulness Meditation for Patients ...

The GEMM Trial: Graded Exposure and Mindfulness Meditation for Patients Post-ACL Reconstruction. The purpose of this study is to examine the efficacy of a 5 ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10784889/

Psychological Readiness, Injury-Related Fear, and ...

Graded exposure therapy and ACTs are specific psychological interventions that may improve overall psychological health and decrease persistent ...