DepressionNCT05965310
Anterior Cruciate Ligament Recovery With Virtual Psychological Intervention
A study testing Virtual Psychological Intervention: Cognitive Behavioral Therapy in people with Depression and Anterior Cruciate Ligament Injuries, run by Henry Ford Health System at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Depression, Anterior Cruciate Ligament Injuries, Mental Health Issue
- What is being tested?
- Virtual Psychological Intervention: Cognitive Behavioral Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2023to Mar 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 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients over the age of 12 with ACL injuries undergoing ACLR with a Henry Ford Sports Orthopedic Surgeon
- First time ACLR on the injured knee
Who cannot join
- Patients undergoing revision ACL surgery
- Concomitant posterior cruciate ligament injury of the involved knee
- Systemic or local infection pre-operatively
- Systemic administration of any type of corticosteroid or immunosuppressive agents within 30 days of surgery
- History of rheumatoid arthritis, inflammatory arthritis, or autoimmune diseases
- Pregnancy
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
Henry Ford Health System
Detroit, Michigan, 48202
Maxim Jani, BS, 2488240579, mjani1@hfhs.org
About this study
Official title: Randomized Control Trial of the Impact of a Virtual Psychological Intervention on the Outcomes of ACLR
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.
Read the detailed description
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)
- Being tested
- Virtual Psychological Intervention: Cognitive Behavioral Therapy
- Medical subject headings
- Depression, Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Psychological Intervention: Cognitive Behavioral TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Virtual Psychological Intervention: Cognitive Behavioral Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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
Measured: 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.
Measured: 3,6,12 and 24 months
Secondary outcomes (2)
Post-operative opioid usage
the amount of usage of opioid medication post-operatively
Measured: 0-24 months post-operatively
Number of patients with Utilization of additional counseling options (i.e., referral to behavioral health services)
Utilization of additional counseling options (i.e., referral to behavioral health services)
Measured: 0-24 months post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2023
- Study start1 Sep 2023
- Primary completionJan 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe 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
- Model description
- This study is a parallel arm prospective randomized-controlled trial.
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Lynch, Henry Ford Health System
- Investigators
- Thomas Sean Lynch, MD, Principal investigator, Henry Ford Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05965310
- Sponsor's protocol ID
- 16012
- Status last verified
- Jun 2026
- First submitted
- 20 Jul 2023
- Last updated
- 27 Aug 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 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Control Trial of the Impact of a Virtual Psychological Intervention on the Outcomes of ACLR
- ClinicalTrials.gov ID
- NCT05965310
- Acronym / sponsor ID
- 16012
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 28 Jul 2023 (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 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.
Detailed description
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)
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- This study is a parallel arm prospective randomized-controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Standard Post-Operative Rehabilitation | No intervention | –No intervention, patients will receive the standard level of care. |
| Virtual Psychological Intervention | Active comparator | Behavioral: Virtual Psychological Intervention: Cognitive Behavioral TherapyAn 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. |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients over the age of 12 with ACL injuries undergoing ACLR with a Henry Ford Sports Orthopedic Surgeon
- First time ACLR on the injured knee
Key exclusion criteria (6 listed)
- Patients undergoing revision ACL surgery
- Concomitant posterior cruciate ligament injury of the involved knee
- Systemic or local infection pre-operatively
- Systemic administration of any type of corticosteroid or immunosuppressive agents within 30 days of surgery
- History of rheumatoid arthritis, inflammatory arthritis, or autoimmune diseases
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 |
|---|---|---|
| Virtual Psychological Intervention: Cognitive Behavioral TherapyAn 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. | Behavioural | Virtual Psychological Intervention |
Primary outcome
Number of patients who Return to Sport at time set-points
Time frame: 3,6,12 and 24 months
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.
Patient-Reported Outcome Measurement Information System (PROMIS) scores for Physical Function and Pain Interference
Time frame: 3,6,12, and 24 months
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.
Patient Health Questionnaire-2 (PHQ-2) scores
Time frame: 3,6,12, and 24 months
Avalidated depression screening questionnaire with 3 points or more meaning a positive screen
ACL-Return to Sport after Injury (ACL-RSI) scores
Time frame: 3,6,12 and 24 months
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.
2 secondary outcomes
Post-operative opioid usage
Time frame: 0-24 months post-operatively
Number of patients with Utilization of additional counseling options (i.e., referral to behavioral health services)
Time frame: 0-24 months post-operatively
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 27 Aug 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.
Thomas Sean Lynch, MD principal investigator
Henry Ford Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Psychological Intervention: Cognitive Behavioral Therapy in people with Depression and Anterior Cruciate Ligament Injuries, run by Henry Ford Health System 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 6 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 27 Aug 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?
Contact Maxim Jani, BS (2488240579, mjani1@hfhs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients who Return to Sport at time set-points (time frame: 3,6,12 and 24 months). The study lists 4 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 27 Aug 2026.