ACLNCT05542563
Mindfulness and ACL Surgery
A study testing Healthy Minds Program (HMP) App in people with ACL and ACL Injury, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 16 to 40 years
- Conditions the study is for
- ACL, ACL Injury
- What is being tested?
- Healthy Minds Program (HMP) App
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2022to Aug 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 16 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 16-40 years old at the time of the pre-operative visit
- Regular access to a mobile device compatible with the Healthy Minds Program (HMP) App (Android or iOS)
- Undergoing ACL surgery
Who cannot join
- Prior diagnosis of serious mental illness (schizophrenia, bipolar disorder, schizoaffective disorder, etc).
- Significant prior experience with meditation or mindfulness, defined as greater than 30 minutes in a month during the past year
- Knee injury requiring multi-ligament reconstruction
- Prior ipsilateral knee surgery
- Prior contralateral ACL reconstruction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Influence of Mindfulness on Patient-Reported Outcomes, Return to Sport and Re-Injury Following Anterior Cruciate Ligament (ACL) Reconstruction Surgery
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.
Read the detailed description
Rationale and Approach: ACL reconstruction surgery patients experience physical trauma, both in the physical injury itself and following surgery, and face potential adverse long-lasting effects such as muscle weakness, arthritis, persistent knee pain, anxiety, depression, post-traumatic stress, and fear of re-injury. Many of these patients report sufficient psychological trauma that undermines a return to sport and potentially contributes to the risk of re-injury to the repaired knee. 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 following ACL reconstruction surgery.
- Specific Aim 1: To determine the influence of mindfulness training on patient-reported outcomes and return to sport following ACL reconstruction surgery
- Hypothesis 1: Mindfulness training will be associated with improvements in pain, quality of life, depression, anxiety, post-traumatic stress and fear of re-injury, as well as greater likelihood of returning to sport in the 24 months following ACL reconstruction surgery
- Specific Aim 2: To determine the influence of mindfulness training on re-injury risk following ACL reconstruction surgery
- Hypothesis 2: Among those participants that return to sport, mindfulness training will be associated with a decreased risk of ipsilateral ACL rupture in the 24 months following ACL reconstruction surgery
- Specific Aim 3: To determine the factors that influence mindfulness efficacy in patient-reported outcomes and return to sport following ACL reconstruction surgery
- Hypothesis 3: Among participants in the mindfulness group, total duration of mindfulness training and female gender will be independently associated with improvements in pain, quality of life, depression, anxiety, post-traumatic stress and fear of re-injury, as well as greater likelihood of returning to sport in the 24 months following ACL reconstruction surgery
- Conditions
- ACL, ACL Injury
- Being tested
- Healthy Minds Program (HMP) App
- Keywords
- ACL Surgery, mindfulness
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy Minds Program (HMP) AppBehavioural
The full HMP app includes 5 modules with practices designed to cultivate categories of mental and emotional skills linked to both hedonic and eudaimonic well-being. These include the cultivation of mindful attention (Awareness), positive relationships with self and others (Connection), insight into the nature of self and internal experience (Insight), and purpose, values, and meaning in life (Purpose), as well as an initial module which includes abbreviated introductions to the topics and lessons in all four areas (Foundations). For this study, the active intervention will include 4 weeks of training using the Foundations module followed by 4 weeks of training using the Awareness module.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness Intervention plus Standard of Care | Experimental | 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. Receives: Behavioral: Healthy Minds Program (HMP) App |
| Standard of Care | No intervention | Control group receives standard of care only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in PROMIS Global Health Questionnaire (GHQ) Score
Global quality of life (QoL) will be assessed via a 9-item questionnaire scored on a 0-100 scale where higher scores indicate better QoL, pain interference, and fatigue.
Measured: baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
Change in PROMIS Anxiety Questionnaire Score
Anxiety will be assessed via an 8-item questionnaire scored from 0-5 where higher scores represents greater anxiety.
Measured: baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
Change in PROMIS Depression Questionnaire Score
Depression will be assessed via an 8-item questionnaire scored from 0-5 where higher scores represents greater depression.
Measured: baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
Change in Single Assessment Numeric Evaluation (SANE) Score
Pain severity is assessed via a single item survey scored from 0-100 where a higher score indicates greater pain.
Measured: baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
Change in Horowitz Impact of Events Scale Score
Post-traumatic stress is assessed via a 15-item survey scored from 0-3 where higher scores indicate greater level of post-traumatic stress.
Measured: baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
Change in Tampa Scale of Kinesiophobia 11 (TSK-11) Score
Fear of re-injury is assessed via an 11-item survey scored from 1-4 where higher scores indicate a greater fear of re-injury.
Measured: baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
Change in Pain Catastrophizing Scale (PCS) Score
Pain catastrophizing is assessed via a 13-item survey scored from 0-4 where higher scores indicate a higher level of pain catastrophizing.
Measured: baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
Change in Anterior Cruciate Ligament Return to Sport After Injury scale (ACL-RSI) Score
Psychological readiness is assessed via a 12-item survey scored on an 11-point scale where higher scores indicate a higher level of readiness.
Measured: baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
Change in Athletic Identity Measurement Scale (AIMS) Score
Athletic identity is assessed via a 10-item survey with a total range of scores from 10-70 where higher scores indicate a higher level of athletic identity.
Measured: baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
Change in International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form Score
Knee function is assessed via a 10-item survey scored from 0-10 where higher scores means less limitation with activities and less symptoms.
Measured: baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
Change in General physical activity questionnaire (GPAQ) Measured as Minutes of Total Physical Activity per day
Higher score indicates higher physical activity.
Measured: baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
Secondary outcomes (10)
Knee Range of Motion
Measured: 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
Peak Torque
Participants will undergo testing of resisted flexion and extension to determine peak torque
Measured: 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
Peak Torque Relative to Body Weight
Participants will undergo testing of resisted flexion and extension to determine peak torque relative to body weight
Measured: 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
Hamstring to Quadriceps Torque Ratio
Participants will undergo testing of resisted flexion and extension to determine hamstring to quadriceps torque ratio.
Measured: 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
Change in Jump Landing Assessment: Force Measures
loading force, acceleration force, landing force, peak landing force on both legs together
Measured: 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
Change in Jump Height
Measured: 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
Change in Vertical Hop Testing: Force Measures
down force, up force, landing force, peak landing force on a single leg
Measured: 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
Change in Hop Height
Measured: 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
Total Duration of Mindfulness Intervention in the Mindfulness Group
Measured: up to 24 months
Number of Participants Who Return to Sport
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2022
- Study start1 Jul 2022
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ACLStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- a single-blind, randomized controlled trial design to evaluate the effects of a remotely-delivered 8-week mindfulness intervention on patient-reported outcomes following ACL reconstruction surgery
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew Watson, MD, MS, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05542563
- Sponsor's protocol ID
- 2021-0845
- Other IDs
- Protocol Version 10/10/2023, A536110
- Status last verified
- Apr 2026
- First submitted
- 12 Sep 2022
- Last updated
- 29 Apr 2026
- Results posted
- 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 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Mindfulness on Patient-Reported Outcomes, Return to Sport and Re-Injury Following Anterior Cruciate Ligament (ACL) Reconstruction Surgery
- ClinicalTrials.gov ID
- NCT05542563
- Acronym / sponsor ID
- 2021-0845
- Conditions
- ACL, ACL Injury
- Keywords
- ACL Surgery, mindfulness
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 47 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 15 Sep 2022 (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.
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.
Detailed description
Rationale and Approach: ACL reconstruction surgery patients experience physical trauma, both in the physical injury itself and following surgery, and face potential adverse long-lasting effects such as muscle weakness, arthritis, persistent knee pain, anxiety, depression, post-traumatic stress, and fear of re-injury. Many of these patients report sufficient psychological trauma that undermines a return to sport and potentially contributes to the risk of re-injury to the repaired knee. 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 following ACL reconstruction surgery.
- Specific Aim 1: To determine the influence of mindfulness training on patient-reported outcomes and return to sport following ACL reconstruction surgery
- Hypothesis 1: Mindfulness training will be associated with improvements in pain, quality of life, depression, anxiety, post-traumatic stress and fear of re-injury, as well as greater likelihood of returning to sport in the 24 months following ACL reconstruction surgery
- Specific Aim 2: To determine the influence of mindfulness training on re-injury risk following ACL reconstruction surgery
- Hypothesis 2: Among those participants that return to sport, mindfulness training will be associated with a decreased risk of ipsilateral ACL rupture in the 24 months following ACL reconstruction surgery
- Specific Aim 3: To determine the factors that influence mindfulness efficacy in patient-reported outcomes and return to sport following ACL reconstruction surgery
- Hypothesis 3: Among participants in the mindfulness group, total duration of mindfulness training and female gender will be independently associated with improvements in pain, quality of life, depression, anxiety, post-traumatic stress and fear of re-injury, as well as greater likelihood of returning to sport in the 24 months following ACL reconstruction surgery
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- a single-blind, randomized controlled trial design to evaluate the effects of a remotely-delivered 8-week mindfulness intervention on patient-reported outcomes following ACL reconstruction surgery
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Intervention plus Standard of Care | Experimental | Behavioral: Healthy Minds Program (HMP) AppThe 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. |
| Standard of Care | No intervention | –Control group receives standard of care only |
Who may qualify
- Ages
- 16 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 16-40 years old at the time of the pre-operative visit
- Regular access to a mobile device compatible with the Healthy Minds Program (HMP) App (Android or iOS)
- Undergoing ACL surgery
Key exclusion criteria (5 listed)
- Prior diagnosis of serious mental illness (schizophrenia, bipolar disorder, schizoaffective disorder, etc).
- Significant prior experience with meditation or mindfulness, defined as greater than 30 minutes in a month during the past year
- Knee injury requiring multi-ligament reconstruction
- Prior ipsilateral knee surgery
- Prior contralateral ACL reconstruction
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 |
|---|---|---|
| Healthy Minds Program (HMP) AppThe full HMP app includes 5 modules with practices designed to cultivate categories of mental and emotional skills linked to both hedonic and eudaimonic well-being. These include the cultivation of mindful attention (Awareness), positive relationships with self and others (Connection), insight into the nature of self and internal experience (Insight), and purpose, values, and meaning in life (Purpose), as well as an initial module which includes abbreviated introductions to the topics and lessons in all four areas (Foundations). For this study, the active intervention will include 4 weeks of training using the Foundations module followed by 4 weeks of training using the Awareness module. | Behavioural | Mindfulness Intervention plus Standard of Care |
Primary outcome
Change in PROMIS Global Health Questionnaire (GHQ) Score
Time frame: baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
Global quality of life (QoL) will be assessed via a 9-item questionnaire scored on a 0-100 scale where higher scores indicate better QoL, pain interference, and fatigue.
Change in PROMIS Anxiety Questionnaire Score
Time frame: baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
Anxiety will be assessed via an 8-item questionnaire scored from 0-5 where higher scores represents greater anxiety.
Change in PROMIS Depression Questionnaire Score
Time frame: baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
Depression will be assessed via an 8-item questionnaire scored from 0-5 where higher scores represents greater depression.
Change in Single Assessment Numeric Evaluation (SANE) Score
Time frame: baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
Pain severity is assessed via a single item survey scored from 0-100 where a higher score indicates greater pain.
Change in Horowitz Impact of Events Scale Score
Time frame: baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
Post-traumatic stress is assessed via a 15-item survey scored from 0-3 where higher scores indicate greater level of post-traumatic stress.
Change in Tampa Scale of Kinesiophobia 11 (TSK-11) Score
Time frame: baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
Fear of re-injury is assessed via an 11-item survey scored from 1-4 where higher scores indicate a greater fear of re-injury.
Change in Pain Catastrophizing Scale (PCS) Score
Time frame: baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
Pain catastrophizing is assessed via a 13-item survey scored from 0-4 where higher scores indicate a higher level of pain catastrophizing.
Change in Anterior Cruciate Ligament Return to Sport After Injury scale (ACL-RSI) Score
Time frame: baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
Psychological readiness is assessed via a 12-item survey scored on an 11-point scale where higher scores indicate a higher level of readiness.
Change in Athletic Identity Measurement Scale (AIMS) Score
Time frame: baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
Athletic identity is assessed via a 10-item survey with a total range of scores from 10-70 where higher scores indicate a higher level of athletic identity.
Change in International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form Score
Time frame: baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
Knee function is assessed via a 10-item survey scored from 0-10 where higher scores means less limitation with activities and less symptoms.
Change in General physical activity questionnaire (GPAQ) Measured as Minutes of Total Physical Activity per day
Time frame: baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
Higher score indicates higher physical activity.
10 secondary outcomes
Knee Range of Motion
Time frame: 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
Peak Torque
Time frame: 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
Peak Torque Relative to Body Weight
Time frame: 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
Hamstring to Quadriceps Torque Ratio
Time frame: 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
Change in Jump Landing Assessment: Force Measures
Time frame: 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
Change in Jump Height
Time frame: 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
Change in Vertical Hop Testing: Force Measures
Time frame: 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
Change in Hop Height
Time frame: 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
Total Duration of Mindfulness Intervention in the Mindfulness Group
Time frame: up to 24 months
Number of Participants Who Return to Sport
Time frame: up to 24 months
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 29 Apr 2026.
- 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. This study is not recruiting at the moment.
Andrew Watson, MD, MS principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy Minds Program (HMP) App in people with ACL and ACL Injury, run by University of Wisconsin, Madison 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 3 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 29 Apr 2026. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in PROMIS Global Health Questionnaire (GHQ) Score (time frame: baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery). The study lists 11 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 29 Apr 2026; AzTrials last refreshed its copy on 30 Oct 2026.