Efficacy of Cognitive Behavioral Therapy on Fatigue, Cognition and Inf

The Influence of Cognitive Behavioral Therapy on Fatigue, Cognition and Inflammatory Biomarkers in Multiple Sclerosis Patients

CompletedNot a drug-phase studyMS (type not specified)NCT05002062

What it found

No results found

We found no results in the registry or in papers.

This trial finished 5 years ago. We found no results in the registry or in any paper that cites it.

What was tested

Treatment tested

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

What it measured

Main measures

  • Level of primary fatigue

    Changes from baseline to pre-intervention, Changes from Pre-intervention to immediately post intervention

    Fatigue

  • Level of Attention/concentration

    Changes from baseline to pre-intervention, Changes from Pre-intervention to immediately post intervention

    Thinking and memory

  • Figural Memory

    Changes from baseline to pre-intervention, Changes from Pre-intervention to immediately post intervention

    Thinking and memory

  • Mental Reaction behavior

    Changes from baseline to pre-intervention, Changes from Pre-intervention to immediately post intervention

    Thinking and memory

  • Serum levels of Tumor Necrosis Factor-alpha (TNF-alpha) and Interferon-gamma(INF-gamma)

    Changes from baseline to pre-intervention, Changes from Pre-intervention to immediately post intervention

    Immune response

Who could take part

MS (type not specified) · 20 to 45

Show the full criteria

Inclusion criteria

* All types and representations of MS patients were included in this study. - The age of the patients ranged from 20-45 years. - All the patients subjected to a standard neurological examination before participating in the study( sensory, motor, coordination , balance, gait and fundus examination). * All the patients were free from any other neurological problems. * Multiple sclerosis patients were subdivided into two equal groups, (Conventional physical therapy program group)(G1) \& Computer-based Cognitive training program (G2). * All patients in both groups complained from fatigue for more than two months with total score of FSS ≥ 36. * All patients in both groups complained from varying degrees of cognitive decline persisted for more than 3 months. * All the patients were ambulatory with mild to moderate disability according to the expanded disability status scale (EDSS) ≤ 5(Ambulatory without aid or rest for 200 meters). * Main complain for all patients is sense of fatigue with varying degrees of cognitive decline. * All the patients were medically stable with absent or mild hemiparetic, ataxic, motor or sensory manifestations. * All patients were educated .

Exclusion criteria

* Severe visual, verbal or acoustic impairments that may interfere with cognition testing, * Serious chronic illness that could interfere with or modify assessment. * Low leukocyte count \& elevated ESR as this interfere with cytokine levels. * Secondary causes of fatigue including severe depression ( beck depression inventory (BDI ≥ 21) and sleep disturbance ( Epworth sleepiness scale (ESS ≥ 12) * Inability to complete questionnaires study outcome measure as in severe cognitive impairment and illiteracy.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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).

Papers

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    History

      1. Started

        Dec 2020

      2. Main results due

        May 2021

      3. Finished

        Jun 2021

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