Effect of Cognitive Behavioral Therapy on Kinesiophobia and Functional Outcomes After Total Hip Arthroplasty.

February 17, 2026 updated by: Ahmed ElMelhat, Cairo University

Effect of Cognitive Behavioral Therapy on Kinesiophobia and Clinical Outcomes After Total Hip Arthroplasty: A Randomized Controlled Trial.

The goal of this clinical trial study is to evaluate the effectiveness of cognitive behavioral therapy in reducing kinesiophobia and improving Clinical outcomes in postoperative patients following total hip arthroplasty The main question it aims to answer is:

Does the addition of cognitive behavioral therapy to standard physical therapy rehabilitation exercise reduce kinesiophobia and pain while improving functional mobility and quality of life in postoperative patients after total hip arthroplasty ? Participants will be divided into two groups to be compared: the first group (Control group) will only receive standard physical therapy rehabilitation exercises , consistent with routine post-total hip arthroplasty care, while the second group ( experimental group) will receive the same program in addition to cognitive behavioral therapy.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Cognitive behavioral therapy is a psychological therapy that helps individuals modify unhelpful thoughts and behaviors to improve emotions and functioning (American Psychological Association , 2017). Emerging studies have shown that cognitive behavioral therapy is effective in reducing kinesiophobia in postoperative patients after joint athroplasty , with recent evidence specifically in total knee arthroplasty (Sun Et al.,2020).

Thus ,the investigators hypothesize that adding cognitive behavioral therapy (CBT) to a standard physical therapy rehabilitation program will improve kinesiophobia and clinical outcomes after total hip arthroplasty.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • 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 Contact

Study Contact Backup

Study Locations

  • Egypt
    • Giza Governorate
      • Giza, Giza Governorate, Egypt, 2356
        • Recruiting
        • Cairo University Hospitals
        • Contact:

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

((1) postoperative unilateral THA for the first time; (2) at least primary education; (3) ≥18 years of age ; (4) voluntary participation and close cooperation with the care plan; and (5) agreement to continue the intervention and the six-month follow-up after discharge,(6) high level of kinesiophobia on Tampa Scale of Kinesiophobia(TSK), (7)medically stable and cleared by their orthopedic surgeon.

Exclusion Criteria:

(1) revision surgery, (2) severe osteoarthritis in the contralateral hip, (3) severe acute metabolic neuromuscular and cardiovascular disease, (4) body mass index above 40, (5) presence of malignancy, any other orthopedic or neurologic problem that might affect treatment and assessments, (6) any condition that might interfere with communication, (7) or lack of cooperation during the study.(9) Individuals with cognitive disorder,(10) individuals with any psychological disease or disorder,(10) Had previously participated in a CBT intervention,(11) pregnancy.

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: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard Total Hip Arthroplasty Rehabilitation

Standard Total Hip Arthroplasty Rehabilitation will only receive standard THA rehabilitation exercises , consistent with routine post- total hip arthroplasty care.

The program consists of active exercises aimed at restoring mobility , improving strength and movement control and enhancing performance of daily activities during the early postoperative phase
Other: Exercise
The Standard rehabilitation program consisting of active exercises will be delivered over a 12-week period
Experimental: Cognitive Behavioral Therapy with standard THA rehabilitation
The experimental group will receive CBT sessions in addition to the same standard THA rehabilitation exercises delivered to the control group. The cognitive behavioral therapy intervention comprised structured sessions focusing on the identification and modification of maladaptive beliefs related to pain and movement, education regarding postoperative pain, and the development of adaptive coping strategies. The program incorporated cognitive restructuring, graded exposure to functional activities, behavioral activation, and relaxation techniques to reduce kinesiophobia, address fear-avoidance behaviors, and support functional recovery and self-efficacy throughout rehabilitation.
Other: Exercise
The Standard rehabilitation program consisting of active exercises will be delivered over a 12-week period
Behavioral: Cognitive-behavioral therapy
Four Cognitive Behavioral Therapy sessions will be delivered over a 12-week period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tampa Scale of kinesiophobia (TSK)
Time Frame: Day 1 , 6 weeks , 12 weeks, 6 months as follow up.
To assess kinesiophobia ( fear of movement/re-injury) before and after intervention ( at four time points ).This scale uses individual item scores ranging from 1 to 4, where 1 indicates strong disagreement and 4 indicates strong agreement. Four negatively worded items (4, 8, 12, 16) are reverse-scored (4 = 1, 3 = 2, 2 = 3, 1 = 4). The total score ranges from 17 to 68, with higher scores indicating greater kinesiophobia. Scores above 37 are generally considered indicative of clinically relevant kinesiophobia
Day 1 , 6 weeks , 12 weeks, 6 months as follow up.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numerical Pain Rating Scale Score (NPRS)
Time Frame: day 1 , 6 weeks , 12 weeks, 6 months as follow up
To evaluate the effect of Cognitive Behavioral Therapy on pain perception. Scores range from 0 ( no pain) to 10 (worst pain)
day 1 , 6 weeks , 12 weeks, 6 months as follow up
Harris Hip Score (HHS)
Time Frame: day 1 , 6weeks , 12 weeks , 6 months as follow up
To assess hip function, pain, and functional mobility on day 1 , 6weeks , 12 weeks , 6 months after surgery 90-100: excellent 80-89: good 70-79: fair <70: poor
day 1 , 6weeks , 12 weeks , 6 months as follow up
Assessmeny of qulity of life by SF-36 Form
Time Frame: day 1, 6weeks , 12 weeks and 6 months as follow up.

To assess overall health-related quality of life on day 1, 6weeks , 12 weeks and 6 months after surgery. Scores range from 0 ( lowest score )-100 (highest score), with :

Higher scores: better health status and functioning Lower scores: worse health status and functioning
day 1, 6weeks , 12 weeks and 6 months as follow up.

Collaborators and Investigators

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

Sponsor

Cairo University

Investigators

  • Study Director: Ahmed El Melhat, PhD, Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

February 1, 2026

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

February 17, 2026

First Submitted That Met QC Criteria

February 17, 2026

First Posted (Actual)

February 23, 2026

Study Record Updates

Last Update Posted (Actual)

February 23, 2026

Last Update Submitted That Met QC Criteria

February 17, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Cognitive Behavioral Therapy

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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