Athletic InjuriesNCT07217275
Rise With Resilience
A study testing Community Resiliency Model (CRM) in people with Athletic Injuries and Sport Injuries, run by Emory University at 1 site in United States.
Trial summary
The objective of this study is to investigate differences in postoperative pain, physical health, and mental health outcomes between participants receiving evidence-based mindfulness training and those who do not. Read more about this study
- Who is it for?
- Ages 18 to 26 yearsHealthy volunteers can take part
- Conditions the study is for
- Athletic Injuries, Sport Injuries
- What is being tested?
- Community Resiliency Model (CRM)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2025to Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 26 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- College student athletes 18-26 years old,
- Scheduled for orthopedic surgery due to sports medicine injuries (e.g., anterior cruciate ligament tears, meniscus injury, rotator cuff injury, etc.)
Who cannot join
- Individuals unable to provide consent
- Undergoing revision procedures
- Individuals without access to an internet-connected device.
- Unable to speak English
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Emory Orthopaedics and Spine Center
Atlanta, Georgia, 30329
About this study
Official title: Rise With Resilience: A Clinical Trial Examining Mindfulness Training for Enhancing Recovery in Injured Student-Athletes
The objective of this study is to investigate differences in postoperative pain, physical health, and mental health outcomes between participants receiving evidence-based mindfulness training and those who do not.
Over 200,000 injuries are estimated to occur among National Collegiate Athletic Association (NCAA) athletes annually. For many, these injuries can be season-ending, exacerbating physical, mental, and social well-being. Student-athletes face distinctive challenges compared to traditional students, such as balancing academic and athletic demands, pressures to perform well on and off the field, and the physical demands of competition, all of which can lead to worse mental and emotional outcomes if not properly managed. Injuries heighten stress levels among athletes, remove them from competition, and force students to integrate treatment regimens into already packed academic schedules.
Read the detailed description
In this study, researchers will investigate how student-athletes can enhance their recovery following surgery for an injury by incorporating mindfulness-based practices.
Athletic performance, physical output, and overall wellness have been shown to improve when athletes incorporate evidence-based mindfulness and cognitive skills. Yet, minimal research has examined how cognitive and mindfulness skills can be leveraged specifically by injured student athletes to facilitate return to play, mitigate stress, and support academic performance following surgery. This randomized clinical trial will recruit college athletes undergoing surgery due to injury and randomize them to work with an expert on implementing skills from the Community Resiliency Model® (CRM).
Over the span of three months after surgery, the interdisciplinary research team will compare patient-reported outcomes and objective recovery measures from wrist-worn actigraphy devices to determine the impact of educating athletes on incorporating CRM skills that enhance well-being following surgery, compared to standard of care (SOC) written discharge instructions. Participants will complete questionnaires in person and/or via email about their general health and their pain at each appointment.
- Conditions
- Athletic Injuries, Sport Injuries
- Being tested
- Community Resiliency Model (CRM), Control
- Keywords
- Orthopedic surgery, Student Athletes, Mindfulness skills
- Medical subject headings
- Athletic Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community Resiliency Model (CRM)Other
Also called Virtual Intervention
CRM is an evidence-based mindfulness approach that provides patients with a biological perspective on behavioral health and stress reactions. CRM teaches six (6) mindfulness-based skills to address body sensation perception to attenuate symptoms of stress and anxiety, which in turn contribute to reducing pain and stress response. Trained specialists will introduce mindfulness skills to athletes, educate them on how to apply the skills, and observe athletes practicing the skills via Zoom®. Participants will be randomized to work with a mindfulness specialist at the baseline visit for 90 minutes and at follow-up visits for 15-30 minutes over Zoom®. The team's mindfulness specialists will deliver the evidence-based mindfulness training.
ControlOther
Also called Standard of Care (SOC)
Participants will receive written discharge instructions on postoperative pain management interventions given to all patients seeking care at Emory. The handout includes guidance on when to take prescribed pain medications and how to implement non-pharmacological pain management approaches, such as cryotherapy or aroma therapy. To mitigate attention biases, study staff and clinical staff will meet with control arm participants at each follow-up visit for 15-30 minutes to review the handout. This minimally enhanced usual care attention-based control group design has been successfully utilized in other trials to mitigate biases and dropouts.
| Study group | Role | What they receive |
|---|---|---|
| Community Resiliency Model (CRM) | Experimental | Athletes randomized to the intervention will receive education before surgery. The intervention includes pairing participants with a specialist who will introduce mindfulness skills to athletes, educate them on how to apply the skills, and observe athletes practicing the skills via Zoom®. Receives: Other: Community Resiliency Model (CRM) |
| Standard of Care (SOC) | Active comparator | Athletes randomized to the control group will receive standard of care, written instructions, and handouts on postoperative pain management interventions. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function
PROMIS Physical Function measures participants' self-reported capability to conduct physical activity. This includes capturing function in upper extremities and lower extremities (walking or mobility) as well as a respondent's ability to conduct activities of daily living. There are 4-items on the short form questionnaire and respondents report their capabilities to perform each task on a Likert scale from 5, "without any difficulty", to 1, "unable to do". All 4-items' saw scores are summed before being transformed into t-scores ranging from 0 to 100. Higher scores are better and indicate greater physical function.
Measured: Baseline (pre-surgery), 2 weeks, 6 weeks, and 3 months (post-surgery)
Opioid utilization
Inpatient and operating room opioid utilization will be extracted from the electronic health record (EHR) by study staff upon participants' discharge from the hospital. Opioid medication dosage will be transformed to a total universal measure known as morphine milligram equivalent (MME). MME will be averaged over the length-of-stay (LOS) for a daily dosage, known as MME/day. Additionally, the study team will review the participants' EHR at each study time point up to 3 months to determine MME throughout postoperative recovery and rehabilitation. Higher values indicate a greater dosage per day.
Measured: Baseline (pre-surgery), 2 weeks, 6 weeks, and 3 months (post-surgery)
Pain numerical rating scale (NRS)
The NRS requires respondents to rate the intensity of their pain on a defined scale from 0, "no pain", to 10, 'the worst pain imaginable". The NRS is a commonly used pain assessment tool in both clinical practice and research. Higher scores indicate worse pain.
Measured: Baseline (pre-surgery), 2 weeks, 6 weeks, and 3 months (post-surgery)
Secondary outcomes (9)
Mindful Attention Awareness Scale (MAAS)
The MAAS is a validated 15-item scale designed to assess a core characteristic of dispositional mindfulness, namely, open or receptive awareness of and attention to what is taking place in the present. Each item is rated on a 6-point Likert scale (1 = Almost Always, 6 = Almost Never). The mean or total score is calculated, with higher scores indicating greater mindfulness (i.e., more awareness and attention to the present moment), and lower scores indicating more automatic or distracted behavior.
Measured: Baseline (pre-surgery), 2 weeks, 6 weeks, and 3 months (post-surgery)
Connor-Davidson Resilience Scale (CD-RISC)
The Connor-Davidson (CD) Resilience Scale (RISC) assesses the ability to recover from a stressful event. The abbreviated version of this scale, CD-RISC-2, uses two questions from the original CD-RISC that capture the essence of resilience. Question 1, which asks if the respondent is "Able to adapt to change," and question 8, which asks the respondent whether they "Tend to bounce back after illness or hardship," are used in this 2-item abbreviated measure. Range: 0-8 (Each item scored 0 = not true at all to 4 = true nearly all the time.)The abbreviated nature of this scale allows for a quick, valid, and reliable measure of a respondent's self-perceived resilience in the face of a potentially stressful event such as orthopedic surgery. Scoring: Sum the two items. Higher scores = greater resilience. Example: 0-2 = very low resilience; 7-8 = very high resilience.
Measured: Baseline (pre-surgery), 2 weeks, 6 weeks, and 3 months (post-surgery)
Injury-Psychological Readiness to Return to Sport scale (I-PRRS)
This 10-item scale is used to assess mental readiness, asking questions about confidence to play, ability to give 100% effort, and confidence in the ability to be successful upon return to play. Response format: 0-10 Likert scale 90 = Not at all confident/ready and 10 = Very confident/completely ready). Each item asks how confident the athlete feels about aspects such as: Performing at their pre-injury level, coping with pain, re-injury fears, trust in the injured body part, and overall readiness to return. Scoring range: 0-100, with higher scores indicating greater psychological readiness to return to sport and lower scores = more anxiety, doubt, or lack of confidence
Measured: Baseline (pre-surgery), 2 weeks, 6 weeks, and 3 months (post-surgery)
Resilience Scale for Adults
This 33-item scale aims to characterize a respondent's resilience in several contexts and provides a scale ranging from extremely positive outlooks to extremely negative. For example, in response to being asked "in difficult times, my family…", a scale ranging from "keeps a positive outlook on the future" to "views the future as gloomy" is provided to respondents. The breadth of question types included in this resilience scale makes it a comprehensive evaluation of an athlete's ability to respond in times of struggle. Range: 33-231, with each item scored 1-7. Scoring: Mean or total score. Higher scores indicate a greater resilience (stronger protective factors and adaptability), and lower scores indicate lower resilience or more vulnerability to stress.
Measured: Baseline (pre-surgery), 2 weeks, 6 weeks, and 3 months (post-surgery)
ACL-Return to Sport after Injury (ACL-RSI) scale
This 12-item questionnaire asks questions regarding an athlete's emotions, confidence in performance, and appraisal of risk specifically related to knee injury. While this scale has been used exclusively for evaluation of an athlete's return to sport in response to knee injury, it has application to all orthopedic related sports injuries that require surgical intervention. Some questions include: Are you nervous about playing your sport? Do you feel relaxed about playing your sport? Are you afraid of accidentally injuring your knee by playing your sport? Are you confident that you can perform at your previous level of sport participation? Do thoughts of having to go through surgery and rehabilitation again prevent you from playing your sport? Scoring extremely low demonstrates significantly worse return to play outcomes.
Measured: Baseline (pre-surgery), 2 weeks, 6 weeks, and 3 months (post-surgery)
Actigraphy based sleep data
The sleep data will be computed using the Cole-Kripke algorithm, which accurately distinguishes sleep from wakefulness approximately 88% of the time. Participants will receive a screenless actigraphy device and will be trained on how to wear it on their wrist. Higher sleep values indicate better or longer sleep.
Measured: Baseline (pre-surgery) and 2 weeks (post-surgery)
Actigraphy based physical activity intensity
Physical activity intensity will be captured using wrist actigraphy. Participants will receive a screenless actigraphy device and will be trained on how to wear it on their wrist. More frequent periods of higher intensity indicate improved activity.
Measured: Baseline (pre-surgery) and 2 weeks (post-surgery)
Actigraphy based activity time
Activity time will be captured using wrist actigraphy. Participants will receive a screenless actigraphy device and will be trained on how to wear it on their wrist. Longer duration indicates more time spent actively.
Measured: Baseline (pre-surgery) and 2 weeks (post-surgery)
Actigraphy based activity (steps)
Steps will be captured using wrist actigraphy. Participants will receive a screenless actigraphy device and will be trained on how to wear it on their wrist. More steps per day indicate greater physical activity.
Measured: Baseline (pre-surgery) and 2 weeks (post-surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2025
- Study start1 Nov 2025
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Athletic InjuriesStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Collegiate Athletic Association - NCAA
- Responsible party
- Principal investigator, Nicholas A. Giordano, Emory University
- Investigators
- Nicholas A Giordano, PhD, RN, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07217275
- Sponsor's protocol ID
- 2025P011851
- Status last verified
- Dec 2025
- First submitted
- 13 Oct 2025
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rise With Resilience: A Clinical Trial Examining Mindfulness Training for Enhancing Recovery in Injured Student-Athletes
- ClinicalTrials.gov ID
- NCT07217275
- Acronym / sponsor ID
- 2025P011851
- Conditions
- Athletic Injuries, Sport Injuries
- Keywords
- Orthopedic surgery, Student Athletes, Mindfulness skills
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Collegiate Athletic Association - NCAA
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 15 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to investigate differences in postoperative pain, physical health, and mental health outcomes between participants receiving evidence-based mindfulness training and those who do not.
Over 200,000 injuries are estimated to occur among National Collegiate Athletic Association (NCAA) athletes annually. For many, these injuries can be season-ending, exacerbating physical, mental, and social well-being. Student-athletes face distinctive challenges compared to traditional students, such as balancing academic and athletic demands, pressures to perform well on and off the field, and the physical demands of competition, all of which can lead to worse mental and emotional outcomes if not properly managed. Injuries heighten stress levels among athletes, remove them from competition, and force students to integrate treatment regimens into already packed academic schedules.
Detailed description
In this study, researchers will investigate how student-athletes can enhance their recovery following surgery for an injury by incorporating mindfulness-based practices.
Athletic performance, physical output, and overall wellness have been shown to improve when athletes incorporate evidence-based mindfulness and cognitive skills. Yet, minimal research has examined how cognitive and mindfulness skills can be leveraged specifically by injured student athletes to facilitate return to play, mitigate stress, and support academic performance following surgery. This randomized clinical trial will recruit college athletes undergoing surgery due to injury and randomize them to work with an expert on implementing skills from the Community Resiliency Model® (CRM).
Over the span of three months after surgery, the interdisciplinary research team will compare patient-reported outcomes and objective recovery measures from wrist-worn actigraphy devices to determine the impact of educating athletes on incorporating CRM skills that enhance well-being following surgery, compared to standard of care (SOC) written discharge instructions. Participants will complete questionnaires in person and/or via email about their general health and their pain at each appointment.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Community Resiliency Model (CRM) | Experimental | Other: Community Resiliency Model (CRM)Athletes randomized to the intervention will receive education before surgery. The intervention includes pairing participants with a specialist who will introduce mindfulness skills to athletes, educate them on how to apply the skills, and observe athletes practicing the skills via Zoom®. |
| Standard of Care (SOC) | Active comparator | Other: ControlAthletes randomized to the control group will receive standard of care, written instructions, and handouts on postoperative pain management interventions. |
Who may qualify
- Ages
- 18 to 26 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- College student athletes 18-26 years old,
- Scheduled for orthopedic surgery due to sports medicine injuries (e.g., anterior cruciate ligament tears, meniscus injury, rotator cuff injury, etc.)
Key exclusion criteria (4 listed)
- Individuals unable to provide consent
- Undergoing revision procedures
- Individuals without access to an internet-connected device.
- Unable to speak English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Community Resiliency Model (CRM)Also: Virtual InterventionCRM is an evidence-based mindfulness approach that provides patients with a biological perspective on behavioral health and stress reactions. CRM teaches six (6) mindfulness-based skills to address body sensation perception to attenuate symptoms of stress and anxiety, which in turn contribute to reducing pain and stress response. Trained specialists will introduce mindfulness skills to athletes, educate them on how to apply the skills, and observe athletes practicing the skills via Zoom®. Participants will be randomized to work with a mindfulness specialist at the baseline visit for 90 minutes and at follow-up visits for 15-30 minutes over Zoom®. The team's mindfulness specialists will deliver the evidence-based mindfulness training. | Other | Community Resiliency Model (CRM) |
| ControlAlso: Standard of Care (SOC)Participants will receive written discharge instructions on postoperative pain management interventions given to all patients seeking care at Emory. The handout includes guidance on when to take prescribed pain medications and how to implement non-pharmacological pain management approaches, such as cryotherapy or aroma therapy. To mitigate attention biases, study staff and clinical staff will meet with control arm participants at each follow-up visit for 15-30 minutes to review the handout. This minimally enhanced usual care attention-based control group design has been successfully utilized in other trials to mitigate biases and dropouts. | Other | Standard of Care (SOC) |
Primary outcome
Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function
Time frame: Baseline (pre-surgery), 2 weeks, 6 weeks, and 3 months (post-surgery)
PROMIS Physical Function measures participants' self-reported capability to conduct physical activity. This includes capturing function in upper extremities and lower extremities (walking or mobility) as well as a respondent's ability to conduct activities of daily living. There are 4-items on the short form questionnaire and respondents report their capabilities to perform each task on a Likert scale from 5, "without any difficulty", to 1, "unable to do". All 4-items' saw scores are summed before being transformed into t-scores ranging from 0 to 100. Higher scores are better and indicate greater physical function.
Opioid utilization
Time frame: Baseline (pre-surgery), 2 weeks, 6 weeks, and 3 months (post-surgery)
Inpatient and operating room opioid utilization will be extracted from the electronic health record (EHR) by study staff upon participants' discharge from the hospital. Opioid medication dosage will be transformed to a total universal measure known as morphine milligram equivalent (MME). MME will be averaged over the length-of-stay (LOS) for a daily dosage, known as MME/day. Additionally, the study team will review the participants' EHR at each study time point up to 3 months to determine MME throughout postoperative recovery and rehabilitation. Higher values indicate a greater dosage per day.
Pain numerical rating scale (NRS)
Time frame: Baseline (pre-surgery), 2 weeks, 6 weeks, and 3 months (post-surgery)
The NRS requires respondents to rate the intensity of their pain on a defined scale from 0, "no pain", to 10, 'the worst pain imaginable". The NRS is a commonly used pain assessment tool in both clinical practice and research. Higher scores indicate worse pain.
9 secondary outcomes
Mindful Attention Awareness Scale (MAAS)
Time frame: Baseline (pre-surgery), 2 weeks, 6 weeks, and 3 months (post-surgery)
Connor-Davidson Resilience Scale (CD-RISC)
Time frame: Baseline (pre-surgery), 2 weeks, 6 weeks, and 3 months (post-surgery)
Injury-Psychological Readiness to Return to Sport scale (I-PRRS)
Time frame: Baseline (pre-surgery), 2 weeks, 6 weeks, and 3 months (post-surgery)
Resilience Scale for Adults
Time frame: Baseline (pre-surgery), 2 weeks, 6 weeks, and 3 months (post-surgery)
ACL-Return to Sport after Injury (ACL-RSI) scale
Time frame: Baseline (pre-surgery), 2 weeks, 6 weeks, and 3 months (post-surgery)
Actigraphy based sleep data
Time frame: Baseline (pre-surgery) and 2 weeks (post-surgery)
Actigraphy based physical activity intensity
Time frame: Baseline (pre-surgery) and 2 weeks (post-surgery)
Actigraphy based activity time
Time frame: Baseline (pre-surgery) and 2 weeks (post-surgery)
Actigraphy based activity (steps)
Time frame: Baseline (pre-surgery) and 2 weeks (post-surgery)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nicholas A Giordano, PhD, RN principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community Resiliency Model (CRM) in people with Athletic Injuries and Sport Injuries, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicholas A Giordano, PhD, RN (404.727.7980, nicholas.a.giordano@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (time frame: Baseline (pre-surgery), 2 weeks, 6 weeks, and 3 months (post-surgery)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2025.