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

NCT05971797 | Completed DMC

• 1 other identifier: 2020-9
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Depression, Anxiety; Pain

Keywords

Depression; Anxiety; Rational Emotive Behavior Therapy; Arthroplasty; Osteoarthritis; Comorbidities

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (3)

Comorbidities

EXPERIMENTAL

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

Comorbidities control

NO INTERVENTION

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.

No comorbidities

ACTIVE COMPARATOR

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

Interventions

REBT BEHAVIORAL

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.

Comorbidities; No comorbidities

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Federal Center for Traumatology, Orthopedics and Endoprosthetics

Cheboksary, Chuvashskaya Respublika, 429500, Russia

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders; Pain; Osteoarthritis

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD Clinical Assistant Professor

Model Details: Randomized clinical trial in patients with depression or anxiety identified at prior psychological counseling prior to joint replacement surgery with or without comorbidities

Study Record Dates

• First Submitted: July 5, 2023
• First Posted: August 2, 2023
• Study Start: January 1, 2020
• Primary Completion: January 1, 2021
• Study Completion: December 31, 2021
• Last Updated: August 3, 2023

Record last verified: 2023-08

Locations

RU (1)