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The goal of this parallel arm prospective randomized control trial study is to compare outcomes in Anterior Cruciate Ligament Reconstruction (ACLR) Surgery patients after exposure to a virtual psychological intervention (VPI) versus standard care. The main question the investigators are asking is if virtual administration of psychological CBT modules will be an accessible and convenient vehicle to improve ACLR outcomes. Participants will be placed either into a treatment group receiving virtual modules of cognitive behavioral therapy in addition to standard of care ACLR surgery or the control group receiving only the standard of care ACLR surgery. The investigators hypothesize that ACLR patients in the VPI cohort will have improved return to sport and post operative outcomes compared to controls.
This study is a parallel arm prospective randomized-controlled trial. The expected duration of the study is two years. Participants will be placed either into a treatment group receiving virtual modules of cognitive behavioral therapy in addition to standard of care ACLR surgery or the control group receiving only the standard of care ACLR surgery. Trial eligibility criteria are as follows: patients over the age of 12 undergoing first time ACLR with a HFH Sports Orthopedic surgeon. Eligible participants will be randomized using computerized random number generation into two groups: Group A and Group B. Both groups will receive the same standard post-operative rehabilitation protocol. An asynchronous course of pre- and post-operative CBT modules (VPI) will be delivered to patients in Group A as an adjuvant treatment to standard-of-care rehabilitation. Each session is designed to provide patients with different CBT strategies to augment their recovery. Sessions will be delivered virtually by trained health professionals. Participants in Group B will receive standard-of-care rehabilitation only. Demographic information and additional protected health information will be handled securely in a securedatabase. Pre-operative PROMIS and PHQ-2 scores will be obtained for both groups via electronic medical record abstraction. Primary endpoints are as follows: Return to sport, defined as return to pre-injury involvement in the patient's respective sport at 3, 6, 12, and 24 months. Secondary outcomes are as follows: Patient-Reported Outcome Measurement Information System (PROMIS) scores, a validated patient reported outcome instrument, Patient Health Questionnaire-2 (PHQ-2) scores, a validated depression screening questionnaire, ACL-Return to Sport after Injury (ACL-RSI) scores, a validated scale to measure the psychological impact of returning to sport following ACLR3, Post-operative opioid usage and Utilization of additional counseling options (i.e., referral to behavioral health services)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Post-Operative Rehabilitation | No Intervention | No intervention, patients will receive the standard level of care. | |
| Virtual Psychological Intervention | Active Comparator | An asynchronous course of pre- and post-operative CBT modules (VPI) will be delivered to patients in Group A as an adjuvant treatment to standard-of-care rehabilitation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual Psychological Intervention: Cognitive Behavioral Therapy | Behavioral | An asynchronous course of pre- and post-operative CBT modules (VPI) will be delivered to patients in Group A as an adjuvant treatment to standard-of-care rehabilitation. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients who Return to Sport at time set-points | Comparing number of patients who Return to sport, defined as return to pre-injury involvement in the patient's respective sport at 3, 6, 12, and 24 months in each trial group. | 3,6,12 and 24 months |
| Patient-Reported Outcome Measurement Information System (PROMIS) scores for Physical Function and Pain Interference | Comparing in each trial group, A validated patient reported outcome instrument where 50 is the average reference score of the patient population and the standard deviation is 10. For PROMIS measures, higher scores equals more of the concept being measured (e.g., more Pain Interference, more Physical Function). Thus a score of 60 is one standard deviation above the average referenced population. This could be a desirable or undesirable outcome, depending upon the concept being measured. | 3,6,12, and 24 months |
| Patient Health Questionnaire-2 (PHQ-2) scores | Avalidated depression screening questionnaire with 3 points or more meaning a positive screen | 3,6,12, and 24 months |
| ACL-Return to Sport after Injury (ACL-RSI) scores | A validated scale to measure the psychological impact of returning to sport following ACLR. There are three domains: risk appraisal, confidence, and emotions. A total score between 0 and 100 is calculated by adding and averaging the scores for each item. Greater psychological preparation is indicated by higher scores. | 3,6,12 and 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative opioid usage | the amount of usage of opioid medication post-operatively | 0-24 months post-operatively |
| Number of patients with Utilization of additional counseling options (i.e., referral to behavioral health services) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Brittaney Pratt | Contact | 8502842125 | bpratt1@hfhs.org |
| Name | Affiliation | Role |
|---|---|---|
| Thomas Sean Lynch, MD | Henry Ford Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henry Ford Health System | Recruiting | Detroit | Michigan | 48202 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 17, 2024 | Jul 17, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 5, 2024 | Jul 17, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D000070598 | Anterior Cruciate Ligament Injuries |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D007718 | Knee Injuries |
| D007869 | Leg Injuries |
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This study is a parallel arm prospective randomized-controlled trial.
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Utilization of additional counseling options (i.e., referral to behavioral health services)
| 0-24 months post-operatively |
| D014947 |
| Wounds and Injuries |