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

August 2, 2023 updated by: Emelianov Vladimir, Federal State Budgetary Organization, Federal Center for Traumatology, Orthopedics and Arthroplasty

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
95

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
STAI
Time Frame: 2 days after surgery
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
Time Frame: 2 days after surgery
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Federal State Budgetary Organization, Federal Center for Traumatology, Orthopedics and Arthroplasty

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Chuvash State University named after I.N. Ulyanov

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 5, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 25, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 2, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 3, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 2, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

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