Rational-emotional Behavioral Therapy (REBT) in Patients With Osteoarthritis and Concomitant Diseases Before Arthroplasty (REBT)

Rational-emotional Behavioral Therapy in Patients With Osteoarthritis and Concomitant Diseases Before Knee or Hip Arthroplasty

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.

Study Overview

• Status: Completed
• Conditions: Pain; Depression, Anxiety
• Intervention / Treatment: Behavioral: REBT

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 95
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russian Federation
  • Chuvashia
    • Cheboksary, Chuvashia, Russian Federation, 429500
      • Federal Center for Traumatology, Orthopedics and Endoprosthetics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients enrolled for the primary knee or hip arthroplasty (M15.0, M16, M17) before operation.

Exclusion Criteria:

• Other types of psychiatric pathology
• Reluctance to undergo psychological correction
• Failure to pass pre-test
• Ongoing follow-up with a psychologist or psychiatrist

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Comorbidities control; 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.
Active Comparator: No comorbidities; 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.	Behavioral: REBT; 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.
Experimental: Comorbidities; 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.	Behavioral: REBT; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
STAI	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.	2 days after surgery
HADS	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.	2 days after surgery

Collaborators and Investigators

• Sponsor: Federal State Budgetary Organization, Federal Center for Traumatology, Orthopedics and Arthroplasty
• Collaborators: Chuvash State University named after I.N. Ulyanov

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Actual): January 1, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: July 5, 2023
• First Submitted That Met QC Criteria: July 25, 2023
• First Posted (Actual): August 2, 2023

Study Record Updates

• Last Update Posted (Actual): August 3, 2023
• Last Update Submitted That Met QC Criteria: August 2, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Depression; Osteoarthritis; Anxiety; Arthroplasty; Comorbidities; Rational Emotive Behavior Therapy
• Additional Relevant MeSH Terms: Behavioral Symptoms; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Depression; Osteoarthritis
• Other Study ID Numbers: 2020-9

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No