Total Knee Arthroplasty Combined With Psychological Intervention for Patients With Psychological Disorders
Condition: Osteoarthritis, Knee; Psychological Disorder; Psychological Intervention; Satisfaction; Total Knee Arthroplasty
MeSH terms: Osteoarthritis, Knee; Mental Disorders
Study type: Interventional

Summary: 
      Objective To evaluate the incidence of psychological problems in total knee arthroplasty
      (TKA) patients and examine whether perioperative psychological intervention can improve the
      outcomes of and patient satisfaction with TKA.

      Methods The investigators will prospectively collect clinical data from 400 patients who
      underwent primary TKA by the same surgeon at Peking University Third Hospital. The patients
      will be divided into 3 groups based on psychological status and intervention: the normal
      group comprised patients with a normal psychological status, while patients with an abnormal
      psychological status will be randomly divided into the intervention group, which received
      psychological interventions, and the control group, which do not receive any psychological
      interventions. The HSS（Hospital of special surgery） and WOMAC scores will be evaluated
      preoperatively, 3 months postoperatively and 6 months postoperatively. A self-administered
      satisfaction scale (very satisfied, somewhat satisfied, somewhat dissatisfied, very
      dissatisfied) that assessed overall satisfaction as well as satisfaction with pain relief and
      the ability to perform daily and leisure activities will be administered 6 months
      postoperatively.

      Hypothesis A certain percentage of TKA patients have preoperative psychological
      abnormalities. Preoperative psychological abnormalities can have an adverse effect on
      postoperative improvement in joint function and can reduce patient satisfaction. Preoperative
      psychological intervention can improve the prognosis of TKA patients with psychological
      disorders.
    

Detailed description: 
      Patients with knee osteoarthritis（OA） undergoing primary unilateral TKA at the Department of
      Orthopedics of Peking University Third Hospital from May 2016 to January 2018 will be
      prospectively included in the study. Inclusion criteria: (1) Signed written informed consent;
      (2) Willingness to complete the assessment and an examination using a psychometric scale; (3)
      No surgical contraindications. Exclusion criteria: (1) Patients undergoing revision; (2)
      Patients with infection; (3) Patients who could not undergo the psychological assessment; (4)
      Loss to follow-up; (5) Psychological disorders of severe type, which means the patient needs
      to stop TKA surgery for psychological therapy. The patients' general preoperative data and
      joint function scores will be collected. Preoperative psychoanalysis will be conducted by a
      psychiatrist from Peking University Sixth Hospital to determine the TKA patients'
      preoperative psychological characteristics.

      According to the presence or absence of psychological abnormalities, the patients will be
      divided into a psychological abnormalities group and a normal group. The patients in the
      normal group will receive routine TKA surgery and perioperative management without any other
      interventions.

      A randomized controlled prospective study will be conducted with the patients in the
      psychological abnormalities group. They will be randomly divided into two groups: the
      intervention group and the control group.

      The control group: Like the patients in the normal group, the patients in the control group
      will receive routine TKA surgery and perioperative management without any other
      interventions.

      The intervention group: The patients in the intervention group will receive psychological
      counseling and corresponding medication after the operation. Other perioperative treatments
      will be the same as the patients in the control group. Psychotherapy will be based on the
      clinical expertise of the psychosocial specialist, who will select the most appropriate plan
      for each patient.

      The WOMAC and HSS scores of all patients will be analyzed preoperatively, 3 months
      postoperatively and 6 months postoperatively, and a postoperative satisfaction survey
      questionnaire will be completed.

      For every patient in this study, standard TKA and perioperative management will be performed
      by one experienced surgeon at Peking University Third Hospital. Postoperative follow-up will
      be performed by a group of doctors who are blinded to the group and intervention information.

      Psychological status assessment and clinical outcome evaluation The patients' psychological
      and physical performance will be assessed using the Symptom Checklist (SCL-90), a
      self-assessment questionnaire that is commonly used to assess patients' psychological health.
      The SCL-90 has a good ability to identify people with psychological symptoms (especially
      patients on the border of clinically significant psychological symptoms).

      To assess whether a patient had a psychological disorder that met the diagnostic criteria
      before surgery, the MINI-International Neuropsychiatric Interview (MINI) will be used to
      assess patients with suspected anxiety or depression. The MINI is a short, structured
      interview for the diagnosis of Diagnostic and Statistical Manual-IV（DSM-IV）and International
      Classification of Diseases-10（ICD-10 ） axis psychiatric disorders. It can be conducted in a
      short period of time (average 15 minutes). The Chinese version of the MINI has shown
      reliability and validity in clinical practice. It has been widely used clinically in China.

      The HSS and WOMAC scores will be evaluated preoperatively, 3 months postoperatively and 6
      months postoperatively.

      A self-administered satisfaction scale (very satisfied, somewhat satisfied, somewhat
      dissatisfied, very dissatisfied) that assessed overall satisfaction as well as satisfaction
      with pain relief and the ability to perform daily and leisure activities will be administered
      6 months postoperatively.

      Psychological intervention There are three main interventions for TKA patients: patient
      visits and education, medication, and psychological interventions.

        1. Patient visits and education: Patient education can shorten hospital stays, reduce
           surgical complications, relieve preoperative anxiety and depressive symptoms, increase
           confidence, and improve patient satisfaction. In particular, patients with clear
           psychological problems should pay attention to and divert disease-related negative
           emotions, such as tension, fear, depression and anxiety.

        2. Drug treatment：Patients who meet the indications for drug treatment should be treated
           with drugs that are sensitive and effective as recommended by psychiatrists.

           2.1 Antidepressants are usually divided into tricyclic antidepressants, tetracyclic
           antidepressants, monoamine oxidase inhibitors, selective serotonin reuptake inhibitors
           (SSRIs), dopamine reuptake inhibitors, serotonin and desmethyl selective serotonin and
           norepinephrine reuptake inhibitors (SNRIs), norepinephrine and specific serotonin
           antidepressants. Among them, SSRIs and SNRIs are widely used in clinical practice. The
           SSRIs are fluoxetine hydrochloride, paroxetine hydrochloride, sertraline, fluvoxamine,
           citalopram and escitalopram. The main SNRI drugs are venlafaxine, duloxetine and
           milnacipran.

           2.2 Anti-anxiety drugs are mainly benzodiazepines, such as diazepam, alprazolam, and
           clonazepam, and aromatic piperazine anxiolytics, such as buspirone.

        3. Psychological interventions include cognitive and behavioral therapy, supportive
           therapy, relaxation therapy, and such methods as group therapy, motivational interview
           therapy, and interpersonal psychotherapy.

      Each patient has his or her own psychological characteristics. It most effective for a
      psychiatrist to develop a personalized psychological intervention program based on the
      patient's psychological characteristics.

      Ethics approval This study has been approved by the Ethics Committee of Peking University
      Third Hospital. The enrolled patients can choose to withdraw unconditionally at any time
      during the study, and the investigators guarantee that the patient's TKA surgery would
      continue unaffected.

      Statistical analysis The data distribution will be normal according to the Kolmogorov-Smirnov
      test. Descriptive statistics will be used to analyze the demographic data and other baseline
      features, and the number, mean, and standard deviation values will be calculated for
      continuous variables. Pearson correlations and paired T tests for preoperative and
      postoperative data comparisons will be used to evaluate the relationship between different
      variables. The inferential statistics results (P values) are listed as descriptive results.
      SPSS (Version 19, SPSS, Inc., Chicago IL) will be used for the statistical analysis.
    

Intervention name(s): Psychological Intervention
Intervention type(s): Other
Intervention description(s): The patients in the intervention group received psychological counseling and corresponding medication after the operation. Psychotherapy was based on the clinical expertise of the psychosocial specialist from Peking University Sixth Hospital, who selected the most appropriate plan for each patient.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment