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Efficacy of Cognitive Behavioral Therapy on Fatigue, Cognition and Inflammatory Biomarkers in MS Patients

NCT05002062 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2022-01-18

No results posted yet for this study

Summary

There is a rising concern about quality of life of multiple sclerosis (MS) patients has emerged. Cognitive dysfunction with primary fatigue and there correlation to the level of disease inflammatory process has got great interest in MS research .

The aim of the present study was to examine the influence of using a computer-based cognitive behavioral therapy on primary fatigue, cognitive dysfunction, and inflammatory biomarkers for patients with MS.

Patients and methods A total of 40 MS patients (Expanded Disability Status Scale\<5) were divided into two groups, both groups are suffering cognitive decline (using RehaCom software to assess attention/concentration, memory and reaction behavior) with primary fatigue according to the Fatigue Severity Scale (FSS\>36). Patients with depression and sleep problems were excluded from the study. Patients in both groups have elevated serum levels of tumor necrosis factor-α (TNF-α) and interferon-γ (IFN-γ).

Patients in (G1) underwent conventional physical therapy program for MS including aerobic training, resistive training and a flexibility program, patients in (G2) underwent an intensive computer-based cognitive program for attention, concentration, memory and reaction behavior using the RehaCom software.

The conventional physical therapy interventions for both (G1) sustained for three months, 45 minutes to 1 hour, 3 times/week. The computer-based cognitive behavioral therapy for patients in (G2) was prescribed as following (45 minutes to 1 hour a session, 3 times/week for continues three months).

Conditions

Interventions

DEVICE

"RehaCom" computer-based cognitive training in addition to Conventional physical therapy program

Rehacom procedure: It is a computer-based intensive cognitive rehabilitation test used to assess patient's cognitive functions. It includes 32 assessment tasks for attention, memory , logical reasoning\& executive functioning. It composes of regular PC , 1G RAM , DVD drive, 100 GB hard drive with windows XP SP3, 128 MB RAM direct 3D graphic card , Screen at least 19" , regular PC keyboard or Rehacom panel \& printer .The Rehacom software version is (patient enpult (1990-1997) EN/ISO-13485-certified). It is characterized by easy handling, close to reality , motivating for patients.

OTHER

Conventional physical therapy program

Conventional physical therapy program for MS patients include aerobic training, resistive training and flexibility program

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Principal Investigators

  • Moshera H Darwish, PhD · Cairo University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-21
Primary Completion
2021-05-18
Completion
2021-06-07

Countries

  • Egypt

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05002062 on ClinicalTrials.gov