xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05965310</url>
    </required_header>
    <id_info>
      <org_study_id>16012</org_study_id>
      <nct_id>NCT05965310</nct_id>
    </id_info>
    <brief_title>Anterior Cruciate Ligament Recovery With Virtual Psychological Intervention</brief_title>
    <official_title>Randomized Control Trial of the Impact of a Virtual Psychological Intervention on the Outcomes of ACLR</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Henry Ford Health System</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Henry Ford Health System</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        To our knowledge, no studies have compared a virtual psychological intervention (VPI) to&#xD;
        standard care in a randomized control trial format. We believe virtual administration of&#xD;
        psychological CBT modules will be an accessible and convenient vehicle to improve ACLR&#xD;
        outcomes. The purpose of our study is to apply and assess the outcomes of ACLR patients after&#xD;
        undergoing VPI in comparison to a control cohort. We hypothesize that ACLR patients in the&#xD;
        VPI cohort will have improved return to sport and post operative outcomes compared to&#xD;
        controls. This study is a parallel arm prospective randomized-controlled trial. The expected&#xD;
        duration of the study is two years. Trial eligibility criteria are as follows: patients over&#xD;
        the age of 12 undergoing first time ACLR with a HFH Sports Orthopedic surgeon.An asynchronous&#xD;
        course of pre- and post-operative CBT modules (VPI) will be delivered to patients in Group A&#xD;
        as an adjuvant treatment to standard-of-care rehabilitation. Each session is designed to&#xD;
        provide patients with different CBT strategies to augment their recovery. Sessions will be&#xD;
        delivered virtually by trained health professionals. Participants in Group B will receive&#xD;
        standard-of-care rehabilitation only. Outcomes measured willl include return to sport at 3,&#xD;
        6, 12 and 24 months, PROMIS scores, PHQ-2 scores, ACL-RSI scores, post-op opioid usage.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Design&#xD;
  &#xD;
        This study is a parallel arm prospective randomized-controlled trial. The expected duration&#xD;
        of the study is two years. Trial eligibility criteria are as follows: patients over the age&#xD;
        of 12 undergoing first time ACLR with a HFH Sports Orthopedic surgeon.&#xD;
  &#xD;
        Randomization&#xD;
  &#xD;
        Eligible participants will be randomized using computerized random number generation into two&#xD;
        groups: Group A and Group B. Both groups will receive the same standard post-operative&#xD;
        rehabilitation protocol.&#xD;
  &#xD;
        Treatment&#xD;
  &#xD;
        An asynchronous course of pre- and post-operative CBT modules (VPI) will be delivered to&#xD;
        patients in Group A as an adjuvant treatment to standard-of-care rehabilitation. Each session&#xD;
        is designed to provide patients with different CBT strategies to augment their recovery.&#xD;
        Sessions will be delivered virtually by trained health professionals. Participants in Group B&#xD;
        will receive standard-of-care rehabilitation only.&#xD;
  &#xD;
        Outcomes&#xD;
  &#xD;
        Demographic information and additional protected health information will be handled securely&#xD;
        in a REDCap database. Pre-operative PROMIS and PHQ-2 scores will be obtained for both groups&#xD;
        via electronic medical record abstraction. Primary and secondary endpoints are as follows:&#xD;
  &#xD;
          -  Primary Endpoint&#xD;
  &#xD;
             o Return to sport, defined as return to pre-injury involvement in the patient's&#xD;
             respective sport at 3, 6, 12, and 24 months.&#xD;
  &#xD;
          -  Secondary Endpoints&#xD;
  &#xD;
               -  Patient-Reported Outcome Measurement Information System (PROMIS) scores, a&#xD;
                  validated patient reported outcome instrument1&#xD;
  &#xD;
               -  Patient Health Questionnaire-2 (PHQ-2) scores, a validated depression screening&#xD;
                  questionnaire2&#xD;
  &#xD;
               -  ACL-Return to Sport after Injury (ACL-RSI) scores, a validated scale to measure the&#xD;
                  psychological impact of returning to sport following ACLR3&#xD;
  &#xD;
               -  Post-operative opioid usage&#xD;
  &#xD;
               -  Utilization of additional counseling options (i.e., referral to behavioral health&#xD;
                  services)&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">July 20, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">July 31, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>This study is a parallel arm prospective randomized-controlled trial.</intervention_model_description>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>Single (Care Provider)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Return to Sport</measure>
      <time_frame>3,6,12 and 24 months</time_frame>
      <description>Return to sport, defined as return to pre-injury involvement in the patient's respective sport at 3, 6, 12, and 24 months.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Patient-Reported Outcome Measurement Information System (PROMIS) scores</measure>
      <time_frame>3,6,12, and 24 months</time_frame>
      <description>A validated patient reported outcome instrument</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Patient Health Questionnaire-2 (PHQ-2) scores</measure>
      <time_frame>3,6,12, and 24 months</time_frame>
      <description>a validated depression screening questionnaire</description>
    </primary_outcome>
    <primary_outcome>
      <measure>ACL-Return to Sport after Injury (ACL-RSI) scores</measure>
      <time_frame>3,6,12 and 24 months</time_frame>
      <description>a validated scale to measure the psychological impact of returning to sport following ACLR</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Post-operative opioid usage</measure>
      <time_frame>0-24 months post-operatively</time_frame>
      <description>the amount of usage of opioid medication post-operatively</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Utilization of additional counseling options (i.e., referral to behavioral health services)</measure>
      <time_frame>0-24 months post-operatively</time_frame>
      <description>Utilization of additional counseling options (i.e., referral to behavioral health services)</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Depression</condition>
    <condition>Anterior Cruciate Ligament Injuries</condition>
    <condition>Mental Health Issue</condition>
    <arm_group>
      <arm_group_label>Standard Post-Operative Rehabilitation</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>No intervention, patients will receive the standard level of care.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Virtual Psychological Intervention</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>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.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Virtual Psychological Intervention: Cognitive Behavioral Therapy</intervention_name>
      <description>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.</description>
      <arm_group_label>Virtual Psychological Intervention</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients over the age of 12 with ACL injuries undergoing ACLR with a Henry Ford Sports&#xD;
               Orthopedic Surgeon&#xD;
  &#xD;
            -  First time ACLR on the injured knee&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients undergoing revision ACL surgery&#xD;
  &#xD;
            -  Concomitant posterior cruciate ligament injury of the involved knee&#xD;
  &#xD;
            -  Systemic or local infection pre-operatively&#xD;
  &#xD;
            -  Systemic administration of any type of corticosteroid or immunosuppressive agents&#xD;
               within 30 days of surgery&#xD;
  &#xD;
            -  History of rheumatoid arthritis, inflammatory arthritis, or autoimmune diseases&#xD;
  &#xD;
            -  Pregnancy&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>13 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Brittaney Pratt</last_name>
      <phone>8502842125</phone>
      <email>bpratt1@hfhs.org</email>
    </overall_contact>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 20, 2023</study_first_submitted>
    <study_first_submitted_qc>July 20, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>July 20, 2023</last_update_submitted>
    <last_update_submitted_qc>July 20, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Henry Ford Health System</investigator_affiliation>
      <investigator_full_name>Thomas Lynch</investigator_full_name>
      <investigator_title>Dr. Thomas Lynch</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Anterior Cruciate Ligament Injuries</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05965310
  org study id: 16012
  nct id: NCT05965310
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  To our knowledge, no studies have compared a virtual psychological intervention (VPI) to
        standard care in a randomized control trial format. We believe virtual administration of
        psychological CBT modules will be an accessible and convenient vehicle to improve ACLR
        outcomes. The purpose of our study is to apply and assess the outcomes of ACLR patients after
        undergoing VPI in comparison to a control cohort. We 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. Trial eligibility criteria are as follows: patients over
        the age of 12 undergoing first time ACLR with a HFH Sports Orthopedic surgeon.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. Outcomes measured willl include return to sport at 3,
        6, 12 and 24 months, PROMIS scores, PHQ-2 scores, ACL-RSI scores, post-op opioid usage.
  Design
  
        This study is a parallel arm prospective randomized-controlled trial. The expected duration
        of the study is two years. Trial eligibility criteria are as follows: patients over the age
        of 12 undergoing first time ACLR with a HFH Sports Orthopedic surgeon.
  
        Randomization
  
        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.
  
        Treatment
  
        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.
  
        Outcomes
  
        Demographic information and additional protected health information will be handled securely
        in a REDCap database. Pre-operative PROMIS and PHQ-2 scores will be obtained for both groups
        via electronic medical record abstraction. Primary and secondary endpoints are as follows:
  
          -  Primary Endpoint
  
             o Return to sport, defined as return to pre-injury involvement in the patient's
             respective sport at 3, 6, 12, and 24 months.
  
          -  Secondary Endpoints
  
               -  Patient-Reported Outcome Measurement Information System (PROMIS) scores, a
                  validated patient reported outcome instrument1
  
               -  Patient Health Questionnaire-2 (PHQ-2) scores, a validated depression screening
                  questionnaire2
  
               -  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
  
               -  Utilization of additional counseling options (i.e., referral to behavioral health
                  services)
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: This study is a parallel arm prospective randomized-controlled trial.
  primary purpose: Supportive Care
  masking: Single (Care Provider)
  measure: Return to Sport
  time frame: 3,6,12 and 24 months
  description: Return to sport, defined as return to pre-injury involvement in the patient's respective sport at 3, 6, 12, and 24 months.
  measure: Patient-Reported Outcome Measurement Information System (PROMIS) scores
  time frame: 3,6,12, and 24 months
  description: A validated patient reported outcome instrument
  measure: Patient Health Questionnaire-2 (PHQ-2) scores
  time frame: 3,6,12, and 24 months
  description: a validated depression screening questionnaire
  measure: ACL-Return to Sport after Injury (ACL-RSI) scores
  time frame: 3,6,12 and 24 months
  description: a validated scale to measure the psychological impact of returning to sport following ACLR
  measure: Post-operative opioid usage
  time frame: 0-24 months post-operatively
  description: the amount of usage of opioid medication post-operatively
  measure: Utilization of additional counseling options (i.e., referral to behavioral health services)
  time frame: 0-24 months post-operatively
  description: Utilization of additional counseling options (i.e., referral to behavioral health services)
  arm group label: Standard Post-Operative Rehabilitation
  arm group type: No Intervention
  description: No intervention, patients will receive the standard level of care.
  arm group label: Virtual Psychological Intervention
  arm group type: Active Comparator
  description: 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.
  intervention type: Behavioral
  intervention name: Virtual Psychological Intervention: Cognitive Behavioral Therapy
  description: 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.
  arm group label: Virtual Psychological Intervention
  criteria: 
  gender: All
  minimum age: 13 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Brittaney Pratt
  phone: 8502842125
  email: bpratt1@hfhs.org
  responsible party type: Principal Investigator
  investigator affiliation: Henry Ford Health System
  investigator full name: Thomas Lynch
  investigator title: Dr. Thomas Lynch
  mesh term: Anterior Cruciate Ligament Injuries
  sharing ipd: No