Graded Exposure + Mindfulness for ACL Injury
Recruiting in Palo Alto (17 mi)
+1 other location
Overseen ByShelby E Baez, Ph.D., ATC
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of North Carolina, Chapel Hill
Disqualifiers: Secondary ACL injury, others
Approved in 1 jurisdiction
Trial Summary
What is the purpose of this trial?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.
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 data supports the effectiveness of the treatment Graded Exposure + Mindfulness for ACL Injury?
Research suggests that mindfulness can help improve mood and function in people with various conditions, and differential learning methods can reduce risk factors for ACL injury. These findings indicate that combining mindfulness with graded exposure might be beneficial for ACL injury recovery.
12345Is mindfulness meditation generally safe for humans?
Mindfulness meditation is generally considered safe, but some people may experience anxiety or pain, and in rare cases, more severe reactions like psychosis, especially if the practice is intense or prolonged. These reactions are often influenced by individual factors such as psychological stress and personal history.
678910How does the Graded Exposure + Mindfulness treatment for ACL injury differ from other treatments?
This treatment is unique because it combines graded exposure therapy, which gradually exposes patients to feared activities to reduce avoidance, with mindfulness meditation, which helps improve attention control and reduce anxiety. This combination may help patients manage pain and stress more effectively than traditional physical therapy alone.
711121314Eligibility Criteria
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
I am between 18 and 25 years old.
Injured their knee playing or training for sports (recreational or organized)
I had ACL reconstruction surgery between 1 and 5 years ago.
+2 more
Exclusion Criteria
Do not exhibit elevated injury-related fear
History of secondary ACL injury
I am having other surgeries along with my ACL repair.
Trial Timeline
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
Participant Groups
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).
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.
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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Woollen Gymnasium, 300 South RoadChapel Hill, NC
Fetzer Hall, 210 South RoadChapel Hill, NC
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Who Is Running the Clinical Trial?
University of North Carolina, Chapel HillLead Sponsor
National Athletic Trainers' Association Research & Education Foundation (NATA Foundation)Collaborator
References
Guided imagery to improve functional outcomes post-anterior cruciate ligament repair: randomized-controlled pilot trial. [2022]Imagery can improve functional outcomes post-anterior cruciate ligament repair (ACLR). Research is needed to investigate potential mechanisms for this effect. The aim of this study was to (a) evaluate the effectiveness of an imagery intervention to improve functional outcomes post-ACLR, and (b) explore potential mechanisms. A randomized-controlled pilot trial was conducted. Participants were randomized to guided imagery and standard rehabilitation or standard rehabilitation alone (control). The primary outcome was knee strength 6-month post-operatively. Secondary outcomes were knee laxity at 6-months, and change in psychological (self-efficacy) and neurohormonal (adrenaline, noradrenaline, dopamine) variables. Participants (n=21; 62% male) were 34.86 (SD 8.84) years. Following the intervention, no statistical differences between groups for knee strength extension at 180°/s (t=-0.43, P=0.67), or at 60°/s (t=-0.72, P=0.48) were found. A statistically significant effect was found for knee laxity, F=4.67, P
Bilateral changes in knee joint laxity during the first year after non-surgically treated anterior cruciate ligament injury. [2022]Analyse changes in knee laxity between 3, 6, 12 and 24 months after non-surgically treated ACL injury and to analyse associations between knee laxity and knee function, self-reported knee stability, ACL-Return to Sport after Injury (ACL-RSI), fear and confidence at different timepoints during recovery.
The effect of mindfulness training prior to total joint arthroplasty on post-operative pain and physical function: A randomised controlled trial. [2020]To evaluate the efficacy of Mindfulness-Based Stress Reduction (MBSR) in improving pain and physical function following total joint arthroplasty (TJA).
Mindfulness in Patients with Upper-Extremity Conditions: A Summary of Existing Literature. [2021]Mindfulness implies entering a mental state of awareness which allows for the reframing of an experience, and functionality has shown to be influenced by mindset. The aim of this systematic review was to assess effects of mindfulness in patients with upper-extremity conditions. PubMed, Embase, Cochrane, and CINAHL databases were searched on June 19, 2019, for studies investigating mindfulness in patients with upper-extremity conditions. Two validated instruments for methodologic assessment were used to assess study quality. Studies that reported pain, psychological, or functional outcome measures were included. One randomized controlled trials and three observational studies were included, which together included 335 patients that completed final follow-up. The weighted average age was 52.4 years and 48% of the patients were male. Evaluation of the outcome measures used was immediately after the mindfulness intervention or assessment in all studies. Mindfulness appeared to be positively associated with less pain (though below the minimal clinically important difference), increased mood, and better function. Mindfulness is associated with increased mood and possibly better functionality in adults with a large range of upper-extremity conditions when measured or used as an intervention. Future researcher should expand the subject as only four studies were included in this review. This is a Level IV study.
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. [2022]The current study aimed to compare the possible effects of differential learning strategy, self-controlled feedback, and external focus of attention on kinetic and kinematic risk factors of anterior cruciate ligament (ACL) injury in athletes. Forty-eight male athletes from three sports of handball, volleyball and basketball were selected for this study and were randomly divided into four groups: differential learning (n = 12), self-control feedback (n = 12), external focus (n = 12), and control (n = 12) group. All groups followed the intervention for eight weeks with three sessions per week. Data were analyzed by means of 4 × 2 repeated measures ANOVA followed by post hoc comparison (Bonferroni) at the significance level of p ≤ 0.05. A significant group × time interaction and the main effect of time was found for most kinetic and kinematic variables. The main effect of the group was significant only at the knee abduction angle. Differential learning and external focus of attention methods positively reduced the kinetic and kinematic variables that are considered risk factors for ACL injury. However, the effect sizes (Cohen's d) for the changes in most of the variables were larger for the differential learning group. Tailoring the boundary conditions that are based on the manipulations created in the exercise through variability and variety of movements associated with differential learning methods rather than repeating movements could reduce the risk of ACL injury.
What Are Adverse Events in Mindfulness Meditation? [2022]Mindfulness meditation has become a successful treatment of both physical and psychosocial ailments over the past decade. Mindfulness-Based Stress Reduction (MBSR) and Mindfulness-Based Cognitive Therapy (MBCT) are now implemented in various clinical and hospital settings for the treatment of stress, depression, substance abuse, and chronic pain. However, given mindfulness meditation's exponential rise in popularity, scientific and media reports have called for the evaluation of mindfulness meditation's safety for those who participate in its programs. Studies have described adverse events, such as anxiety and pain, and more severe events like psychosis, that have been associated with mindfulness meditation. However, there has not been a consistent, systematic way to define and report adverse events in meditation randomized control trials. The objective of our viewpoint was to dispel the notion that these emotive feelings and sensations are adverse events due to mindfulness meditation. Instead, they are actually expected reactions involved in the process of achieving the true benefits of mindfulness meditation. For the more severe outcomes of meditation, for example, psychosis and mania, these events are confounded by other factors, such as the intensity and length of the meditative practices as well as psychological stressors and the psychiatric histories of those affected. Comparatively, mindfulness-based programs like MBSR and MBCT are shorter in duration and less intense. They are designed to be adapted to their participants' needs as to not induce pain or panic. Mindfulness meditation teaches its students to learn how to deal with their minds and bodies instead of using maladaptive coping techniques. Thus, we urge that further research in mindfulness meditation consistently use the definition of adverse events as those which lead to severe outcomes or hospitalization.
The Effects of a Mindfulness-Based Program on the Incidence of Injuries in Young Male Soccer Players. [2023]The authors tested the effectiveness of a mindfulness-based program in reducing sport-injury incidence. A total of 168 young male elite soccer players were randomly assigned to mindfulness and control groups. The mindfulness group consisted of seven sessions based on the mindfulness-acceptance-commitment approach, while the control group consisted of seven presentations on sport-injury psychology. Athlete exposure and injury data were recorded during one season. State and trait mindfulness, sport anxiety, stress, and attention control of participants were assessed. Number of injuries, average of injuries per team, and days lost to injury in the mindfulness group were significantly lower than those in the control group. Mindfulness and attention control were lower and sport anxiety and stress were higher in injured players than in noninjured players. Psychological variables were associated with injury. Mindfulness training may reduce the injury risk of young soccer players due to improved mindfulness and attention control and reduced sport anxiety.
First, do no harm: An intensive experience sampling study of adverse effects to mindfulness training. [2021]The study of safety and adverse effects of mindfulness-based interventions (MBIs) is limited. We propose a novel reliable change index (RCI) approach to experience sampling (ES) data to begin to understand the common domains, frequency, severity, risk for, and context of adverse responding to mindfulness meditation practice and brief MBI.
The Empirical Status of Mindfulness-Based Interventions: A Systematic Review of 44 Meta-Analyses of Randomized Controlled Trials. [2022]In response to questions regarding the scientific basis for mindfulness-based interventions (MBIs), we evaluated their empirical status by systematically reviewing meta-analyses of randomized controlled trials (RCTs). We searched six databases for effect sizes based on four or more trials that did not combine passive and active controls. Heterogeneity, moderators, tests of publication bias, risk of bias, and adverse effects were also extracted. Representative effect sizes based on the largest number of studies were identified across a wide range of populations, problems, interventions, comparisons, and outcomes (PICOS). A total of 160 effect sizes were reported in 44 meta-analyses (k = 336 RCTs, N = 30,483 participants). MBIs showed superiority to passive controls across most PICOS (ds = 0.10-0.89). Effects were typically smaller and less often statistically significant compared with active controls. MBIs were similar or superior to specific active controls and evidence-based treatments. Heterogeneity was typically moderate. Few consistent moderators were found. Results were generally robust to publication bias, although other important sources of bias were identified. Reporting of adverse effects was inconsistent. Statistical power may be lacking in meta-analyses, particularly for comparisons with active controls. Because MBIs show promise across some PICOS, future RCTs and meta-analyses should build on identified strengths and limitations of this literature.
Effectiveness of Acceptance and Commitment Therapy in Increasing Resilience and Reducing Attrition of Injured US Navy Recruits. [2019]US Navy recruits who have injuries preventing them from participating in intense physical conditioning are pulled out of boot camp training and receive treatment that includes daily physical therapy, pain medications, and psychoeducational groups. Graduation from boot camp for these recruits requires not only recovering from their injuries but also passing a required Physical Fitness Assessment consisting of a timed 1.5-mile run, curl-ups, and push-ups. About 50-60% of these recruits will eventually be separated out and sent home. The purpose of this study is to examine the effectiveness of an Acceptance and Commitment Therapy (ACT)-based program called Mindfulness for Pain and Performance Enhancement (MPPE). This treatment program was designed to help recruits effectively handle pain and assist them in improving their physical performance in the service of recovery, boot camp completion, and entrance into the Navy.
Psychological Outcomes and Mechanisms of Mindfulness-Based Training for Generalised Anxiety Disorder: A Systematic Review and Meta-Analysis. [2023]This systematic review aimed to identify 1) the effect of mindfulness training on pre-post measures of anxiety and attention among adults experiencing high levels of generalised anxiety; and 2) the impact of predictors, mediators and moderators on post-intervention changes in anxiety or attention. Trait mindfulness and distress measures were included as secondary outcomes. A systematic search was conducted in November 2021 in electronic databases using relevant search terms. Eight articles comprising four independent studies were included (N = 334). All studies included participants diagnosed with generalised anxiety disorder (GAD) who participated in an 8-week manualised program. The meta-analysis indicated that mindfulness training had a large effect on anxiety symptoms (g = -1.92, 95%CI[-3.44, -0.40]) when compared to inactive (i.e., care as usual, waitlist) or non-specified (i.e., condition not defined) controls. However, a significant effect was not found when compared to active controls. Effects for depression, worry and trait mindfulness did not reach statistical significance, despite small-large effect sizes favouring mindfulness compared to inactive/non-specified controls. Our narrative review found evidence that changes in aspects of trait mindfulness mediate anxiety reduction following mindfulness training. However, a small number of studies were available for inclusion in the review, with high risk of bias and low certainty of evidence present. Overall, the findings support the use of mindfulness training programs for GAD and indicate mechanisms that may differ from those involved in other cognitive therapy approaches. Further RCTs with evidence-based controls are needed to clarify techniques most beneficial for generalised anxiety to support individually tailored treatment.
How Does Mindfulness Meditation Work? Proposing Mechanisms of Action From a Conceptual and Neural Perspective. [2022]Cultivation of mindfulness, the nonjudgmental awareness of experiences in the present moment, produces beneficial effects on well-being and ameliorates psychiatric and stress-related symptoms. Mindfulness meditation has therefore increasingly been incorporated into psychotherapeutic interventions. Although the number of publications in the field has sharply increased over the last two decades, there is a paucity of theoretical reviews that integrate the existing literature into a comprehensive theoretical framework. In this article, we explore several components through which mindfulness meditation exerts its effects: (a) attention regulation, (b) body awareness, (c) emotion regulation (including reappraisal and exposure, extinction, and reconsolidation), and (d) change in perspective on the self. Recent empirical research, including practitioners' self-reports and experimental data, provides evidence supporting these mechanisms. Functional and structural neuroimaging studies have begun to explore the neuroscientific processes underlying these components. Evidence suggests that mindfulness practice is associated with neuroplastic changes in the anterior cingulate cortex, insula, temporo-parietal junction, fronto-limbic network, and default mode network structures. The authors suggest that the mechanisms described here work synergistically, establishing a process of enhanced self-regulation. Differentiating between these components seems useful to guide future basic research and to specifically target areas of development in the treatment of psychological disorders.
Self-focused attention and mechanisms of change in mindfulness-based treatment. [2022]The empirical literature provides increasing support for the efficacy of mindfulness training in the treatment of numerous problems and disorders. However, fewer studies have examined the mechanisms through which these beneficial outcomes are obtained. This article summarizes recent research examining three primary questions related to the mechanisms underlying mindfulness-based treatments: do people who practice mindfulness learn to be more mindful of the experiences of daily life? Is an increased general tendency to be mindful related to reduced symptoms and increased well-being? If so, then what psychological processes account for the beneficial effects of increased mindfulness? Recent studies suggest that the practice of mindfulness develops the ability to observe and describe present-moment experiences nonjudgmentally and nonreactively and to participate with awareness in ongoing activity. Increased mindfulness, in turn, appears to mediate improvement in psychological functioning, probably by cultivating an adaptive form of self-focused attention that reduces rumination and emotional avoidance and improves behavioral self-regulation.
The potential mediating role of anxiety sensitivity in the impact of mindfulness training on anxiety and depression severity and impairment: A randomized controlled trial. [2023]The benefits of mindfulness-based interventions to alleviate anxiety and depression have been supported by many studies. Given the effectiveness of mindfulness-based interventions on anxiety and depression, the underlying mechanisms need to be explored. Using a randomized waitlist-controlled design, this study investigated whether anxiety sensitivity was a potential mechanism for the impact of mindfulness training on anxiety and depression. Participants with high psychological distress were randomly assigned to an eight-week mindfulness intervention (N = 35) or a wait-list control group (N = 34). Before and after the intervention or corresponding waitlist period, participants completed measures of anxiety and depression severity and impairment and anxiety sensitivity. Separate mixed ANOVA demonstrated significant group (intervention vs. control group) × time (pre- vs. post-test) interactions for anxiety sensitivity and overall anxiety severity and impairment and marginally significant interaction for overall depression severity and impairment. Moreover, simple mediation models showed that reductions of anxiety sensitivity from pre- to post-test mediated the impact of mindfulness training on changes in anxiety and depression severity and impairment. The findings suggest that anxiety sensitivity is a potential mechanism underlying the effect of mindfulness training on anxiety and depression, which provides a new perspective for the study of processes of change of mindfulness-based interventions.