What side effects are associated with this type of intervention?

Common treatments for Anterior Cruciate Ligament (ACL) injury, such as graded exposure and mindfulness meditation, generally have minimal side effects. Graded exposure may cause temporary discomfort or increased anxiety as activity levels are gradually increased, but these effects typically diminish as patients adapt. Mindfulness meditation is generally safe, though some individuals may experience initial difficulty concentrating or increased awareness of pain. Other common treatments, like physical therapy, may lead to muscle soreness or fatigue, while surgical interventions can carry risks such as infection, blood clots, and complications related to anesthesia.

What prior FDA approvals exist?

The FDA has not specifically approved drugs for the treatment of Anterior Cruciate Ligament (ACL) injuries. Treatment typically involves surgical interventions, physical therapy, and rehabilitation exercises. While there are no FDA-approved medications specifically for ACL injury, pain management may include NSAIDs and other analgesics. The trial studying graded exposure and mindfulness meditation represents a novel approach, focusing on psychological and physical rehabilitation techniques to reduce fear, anxiety, and stress, which are not traditionally addressed by FDA-approved treatments.

What other types of research exist?

Promising novel alternatives for ACL injury patients include: 1) Aquatic exercise, which provides low-impact physical therapy beneficial for joint recovery and pain management. 2) Cognitive Behavioral Therapy (CBT), which helps in managing pain and improving psychological resilience. 3) Acceptance and Commitment Therapy (ACT), which focuses on accepting pain and committing to personal values and goals, shown to be effective in chronic pain management. 4) Eccentric training, which has shown superior results in tendon rehabilitation and could be adapted for ACL recovery.

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Behavioral Intervention

Graded Exposure + Mindfulness for ACL Injury

N/A

Recruiting

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

Research Sponsored by University of North Carolina, Chapel Hill

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up collected at baseline and post-treatment after completion of the intervention or waitlist control at week 5

Summary

This trial tests if gradually facing fears and practicing mindfulness can reduce anxiety and improve reaction times in patients who had ACL surgery. The goal is to help these patients feel less afraid of re-injury and react faster.

Who is the study for?

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.

What is being tested?

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).

What are the potential side effects?

Since this trial involves psychological therapies rather than medication, typical side effects associated with drugs are not expected. Participants may experience emotional discomfort addressing fears.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ collected at baseline and post-treatment after completion of the intervention or waitlist control at week 5

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~collected at baseline and post-treatment after completion of the intervention or waitlist control at week 5

This trial's timeline: 3 weeks for screening, Varies for treatment, and collected at baseline and post-treatment after completion of the intervention or waitlist control at week 5 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Overall Injury-Related Fear

Change in Task Specific Fears

Secondary study objectives

Change in Lower Extremity Reaction Time

Change in Reinjury Anxiety

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Graded Exposure and Mindfulness MeditationExperimental Treatment1 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 ControlPlacebo Group1 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.

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Anterior Cruciate Ligament (ACL) injury, such as Graded Exposure and Mindfulness Meditation, work through different mechanisms to aid recovery. Graded Exposure involves a gradual increase in physical activity to reduce fear and anxiety, helping patients regain confidence and improve functional outcomes by slowly reintroducing them to activities they may avoid due to fear of reinjury. Mindfulness Meditation focuses on mental practices that enhance focus and reduce stress, aiding in pain management and improving overall mental well-being. These treatments are crucial for ACL injury patients as they address both the physical and psychological aspects of recovery, promoting a more holistic and effective rehabilitation process.