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/NCT05971797</url>
    </required_header>
    <id_info>
      <org_study_id>2020-9</org_study_id>
      <nct_id>NCT05971797</nct_id>
    </id_info>
    <brief_title>Rational-emotional Behavioral Therapy (REBT) in Patients With Osteoarthritis and Concomitant Diseases Before Arthroplasty</brief_title>
    <acronym>REBT</acronym>
    <official_title>Rational-emotional Behavioral Therapy in Patients With Osteoarthritis and Concomitant Diseases Before Knee or Hip Arthroplasty</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Federal State Budgetary Organization, Federal Center for Traumatology, Orthopedics and Arthroplasty</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Chuvash State University named after I.N. Ulyanov</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Federal State Budgetary Organization, Federal Center for Traumatology, Orthopedics and Arthroplasty</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The objective of this study was evaluation of the effectiveness of REBT on the emotional&#xD;
        state of orthopedic patients with comorbidities before and after arthroplasty.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The studies assessed depression or anxiety in orthopedic patients by using Spielberger&#xD;
        State-Trait Anxiety Inventory (STAI) and Hospital Anxiety and Depression Scale (HADS) before&#xD;
        and after athroplasty. The comorbid background studied. The orthopedic patients with&#xD;
        comorbidities were divided into several groups: arterial hypertension, chronic pyelonephritis&#xD;
        , varicose veins, cardiovascular disease and atherosclerosis, diabetes mellitus, infection&#xD;
        diseases, gastrointestinal diseases, obesity, neurological disorder, cerebrovascular&#xD;
        accident, iron deficiency anemia, chronic bronchitis, hyperthyroidism, cardiac arrhythmia,&#xD;
        other diseases. Patients with high levels of anxiety and depression underwent Rational&#xD;
        Emotive Behavior Therapy before surgery. Patients without comorbidities and patients with&#xD;
        comorbidities but without exposure considered as a control.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 1, 2020</start_date>
    <completion_date type="Actual">December 31, 2021</completion_date>
    <primary_completion_date type="Actual">January 1, 2021</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>Factorial Assignment</intervention_model>
      <intervention_model_description>Randomized clinical trial in patients with depression or anxiety identified at prior psychological counseling prior to joint replacement surgery with or without comorbidities</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>STAI</measure>
      <time_frame>2 days after surgery</time_frame>
      <description>Each subscale uses a 4-point Likert scale with a range from 1 (&quot;not at all&quot; for S- or &quot;almost never&quot; for T-Anxiety) to 4 (&quot;very much so&quot; for S- and &quot;almost always&quot; for T-Anxiety). Reverse scoring is used for anxiety-absent items (e.g., &quot;I feel calm&quot; or &quot;I am happy&quot;), and therefore, a higher score indicates more severe anxiety with a potential range from 20 to 80 for each subscale. According to the developer scores of 20-39, 40-59, and 60-80 indicate low, moderate, and high anxiety, respectively. Normative values are available in the manual.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>HADS</measure>
      <time_frame>2 days after surgery</time_frame>
      <description>The HADS is a self-report rating scale of 14 items on a 4-point Likert scale (range 0-3). with a range from 0 (&quot;not at all&quot;) to 3 (&quot;most of the time&quot;). Reverse scoring is used for items with positive wording (e.g., &quot;I still enjoy the things I used to enjoy&quot;). The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0-21). A score of 8-10 should be classified as a mild disorder, 11-15 as a moderate disorder, and 16 or more as a severe disorder.</description>
    </primary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Actual">95</enrollment>
    <condition>Depression, Anxiety</condition>
    <condition>Pain</condition>
    <arm_group>
      <arm_group_label>Comorbidities</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Upon admission to the hospital for surgery to replace large joints (knee or hip joints) and diagnosis with osteoarthritis of the knee or hip joint (M15.0, M16, M17), patients with comorbidities underwent 20-minute psychological counseling (PC) session. During PC the levels of depression (F32.0, F32.1 or F32.9) and anxiety (F41.0, F41.1, F41.3, F41.8 or F41.9) were assessed using the STAI and HADS questionnaires. In the experimental group, patients with identified increased levels of depression or anxiety underwent a session of rational-emotional-behavioral therapy, which aimed to modify incorrect thinking patterns. The level of anxiety and depression was reassessed after the surgery.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Comorbidities control</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Upon admission to the hospital for surgery to replace large joints (knee or hip joints) and diagnosis with osteoarthritis of the knee or hip joint (M15.0, M16, M17), patients with comorbidities underwent 20-minute PC. During PC, their levels of depression (F32.0, F32.1 or F32.9) and anxiety (F41.0, F41.1, F41.3, F41.8 or F41.9) were assessed using the STAI and HADS questionnaires. In the first control group, patients with identified increased levels of depression or anxiety did not receive REBT therapy. The level of anxiety and depression was reassessed after the surgery.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>No comorbidities</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Upon admission to the hospital for surgery to replace large joints (knee or hip joints) and diagnosis with osteoarthritis of the knee or hip joint (M15.0, M16, M17), patients without comorbidities underwent 20-minute PC session. During PC the levels of depression (F32.0, F32.1 or F32.9) and anxiety (F41.0, F41.1, F41.3, F41.8 or F41.9) were assessed using the the STAI and HADS questionnaires. In the second control group, patients with identified increased levels of depression or anxiety underwent a session of rational-emotional-behavioral therapy, which aimed to modify incorrect thinking patterns. The level of anxiety and depression was reassessed after the surgery.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>REBT</intervention_name>
      <description>During REBT in patients with osteoarthritis and concomitant diseases with diagnosed depression or anxiety before arthroplasty the patients learn how to manage their irrational or unhealthy emotions, thoughts, and behaviors.</description>
      <arm_group_label>Comorbidities</arm_group_label>
      <arm_group_label>No comorbidities</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients enrolled for the primary knee or hip arthroplasty (M15.0, M16, M17) before&#xD;
               operation.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Other types of psychiatric pathology&#xD;
  &#xD;
            -  Reluctance to undergo psychological correction&#xD;
  &#xD;
            -  Failure to pass pre-test&#xD;
  &#xD;
            -  Ongoing follow-up with a psychologist or psychiatrist&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Federal Center for Traumatology, Orthopedics and Endoprosthetics</name>
        <address>
          <city>Cheboksary</city>
          <state>Chuvashia</state>
          <zip>429500</zip>
          <country>Russian Federation</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Russian Federation</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 5, 2023</study_first_submitted>
    <study_first_submitted_qc>July 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>August 2, 2023</last_update_submitted>
    <last_update_submitted_qc>August 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 3, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Federal State Budgetary Organization, Federal Center for Traumatology, Orthopedics and Arthroplasty</investigator_affiliation>
      <investigator_full_name>Emelianov Vladimir</investigator_full_name>
      <investigator_title>MD PhD Clinical Assistant Professor</investigator_title>
    </responsible_party>
    <keyword>Depression</keyword>
    <keyword>Anxiety</keyword>
    <keyword>Rational Emotive Behavior Therapy</keyword>
    <keyword>Arthroplasty</keyword>
    <keyword>Osteoarthritis</keyword>
    <keyword>Comorbidities</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Osteoarthritis</mesh_term>
      <mesh_term>Depression</mesh_term>
    </condition_browse>
    <!-- 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/NCT05971797
  org study id: 2020-9
  nct id: NCT05971797
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The objective of this study was evaluation of the effectiveness of REBT on the emotional
        state of orthopedic patients with comorbidities before and after arthroplasty.
  The studies assessed depression or anxiety in orthopedic patients by using Spielberger
        State-Trait Anxiety Inventory (STAI) and Hospital Anxiety and Depression Scale (HADS) before
        and after athroplasty. The comorbid background studied. The orthopedic patients with
        comorbidities were divided into several groups: arterial hypertension, chronic pyelonephritis
        , varicose veins, cardiovascular disease and atherosclerosis, diabetes mellitus, infection
        diseases, gastrointestinal diseases, obesity, neurological disorder, cerebrovascular
        accident, iron deficiency anemia, chronic bronchitis, hyperthyroidism, cardiac arrhythmia,
        other diseases. Patients with high levels of anxiety and depression underwent Rational
        Emotive Behavior Therapy before surgery. Patients without comorbidities and patients with
        comorbidities but without exposure considered as a control.
  allocation: Randomized
  intervention model: Factorial Assignment
  intervention model description: Randomized clinical trial in patients with depression or anxiety identified at prior psychological counseling prior to joint replacement surgery with or without comorbidities
  primary purpose: Treatment
  masking: None (Open Label)
  measure: STAI
  time frame: 2 days after surgery
  description: Each subscale uses a 4-point Likert scale with a range from 1 ("not at all" for S- or "almost never" for T-Anxiety) to 4 ("very much so" for S- and "almost always" for T-Anxiety). Reverse scoring is used for anxiety-absent items (e.g., "I feel calm" or "I am happy"), and therefore, a higher score indicates more severe anxiety with a potential range from 20 to 80 for each subscale. According to the developer scores of 20-39, 40-59, and 60-80 indicate low, moderate, and high anxiety, respectively. Normative values are available in the manual.
  measure: HADS
  time frame: 2 days after surgery
  description: The HADS is a self-report rating scale of 14 items on a 4-point Likert scale (range 0-3). with a range from 0 ("not at all") to 3 ("most of the time"). Reverse scoring is used for items with positive wording (e.g., "I still enjoy the things I used to enjoy"). The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0-21). A score of 8-10 should be classified as a mild disorder, 11-15 as a moderate disorder, and 16 or more as a severe disorder.
  arm group label: Comorbidities
  arm group type: Experimental
  description: Upon admission to the hospital for surgery to replace large joints (knee or hip joints) and diagnosis with osteoarthritis of the knee or hip joint (M15.0, M16, M17), patients with comorbidities underwent 20-minute psychological counseling (PC) session. During PC the levels of depression (F32.0, F32.1 or F32.9) and anxiety (F41.0, F41.1, F41.3, F41.8 or F41.9) were assessed using the STAI and HADS questionnaires. In the experimental group, patients with identified increased levels of depression or anxiety underwent a session of rational-emotional-behavioral therapy, which aimed to modify incorrect thinking patterns. The level of anxiety and depression was reassessed after the surgery.
  arm group label: Comorbidities control
  arm group type: No Intervention
  description: Upon admission to the hospital for surgery to replace large joints (knee or hip joints) and diagnosis with osteoarthritis of the knee or hip joint (M15.0, M16, M17), patients with comorbidities underwent 20-minute PC. During PC, their levels of depression (F32.0, F32.1 or F32.9) and anxiety (F41.0, F41.1, F41.3, F41.8 or F41.9) were assessed using the STAI and HADS questionnaires. In the first control group, patients with identified increased levels of depression or anxiety did not receive REBT therapy. The level of anxiety and depression was reassessed after the surgery.
  arm group label: No comorbidities
  arm group type: Active Comparator
  description: Upon admission to the hospital for surgery to replace large joints (knee or hip joints) and diagnosis with osteoarthritis of the knee or hip joint (M15.0, M16, M17), patients without comorbidities underwent 20-minute PC session. During PC the levels of depression (F32.0, F32.1 or F32.9) and anxiety (F41.0, F41.1, F41.3, F41.8 or F41.9) were assessed using the the STAI and HADS questionnaires. In the second control group, patients with identified increased levels of depression or anxiety underwent a session of rational-emotional-behavioral therapy, which aimed to modify incorrect thinking patterns. The level of anxiety and depression was reassessed after the surgery.
  intervention type: Behavioral
  intervention name: REBT
  description: During REBT in patients with osteoarthritis and concomitant diseases with diagnosed depression or anxiety before arthroplasty the patients learn how to manage their irrational or unhealthy emotions, thoughts, and behaviors.
  arm group label: Comorbidities
  arm group label: No comorbidities
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  facility: 
  country: Russian Federation
  responsible party type: Principal Investigator
  investigator affiliation: Federal State Budgetary Organization, Federal Center for Traumatology, Orthopedics and Arthroplasty
  investigator full name: Emelianov Vladimir
  investigator title: MD PhD Clinical Assistant Professor
  mesh term: Osteoarthritis
  mesh term: Depression