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

NCT05002062 | Completed

• 1 other identifier: P.T.REC/012/003199
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Multiple Sclerosis

Outcome Measures

Primary Outcomes (5)

• Level of primary fatigue

  Level of fatigue is assessed using the Fatigue severity scale (FSS) , It is valid and reliable scale used to assess fatigue severity in MS patients. It is self reported questionnaire consisted of nine sentences. A list of statements/questions is provided. These statements are related to the different aspects of fatigue and how it affects the body.Grading of the scale range from " one to seven". Grade (seven) indicate that the patient strongly agrees with a particular statement. Grade (one) indicate the patient strongly disagree to this particular statement (Debouverie et al., 2002). At the end of assessment , if the added total scores were above 36. This indicated that the patient suffer from MS-related fatigue.

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

• Level of Attention/concentration

  Rehacom software is used to assess pre and post treatment cognitive function domains including level of Attention/concentration. Higher scores of attention/concentration indicated better cognitive function and vice versa.

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

• Figural Memory

  Rehacom software is used to assess pre and post treatment cognitive function domains including figural memory. Higher scores of immediate figural memory indicated better cognitive function and vice versa.

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

• Mental Reaction behavior

  Rehacom software is used to assess pre and post treatment cognitive function domains including Mental Reaction behavior. Higher scores of mental reaction behavior indicated better cognitive function and vice versa.

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

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

  The Quantikine Human TNF-alpha \& IFN-gamma Immunoassay ELISA kit . It is a 3.5 or 4.5 hour solid phase ELISA designed to measure human TNF-alpha \& IFN-gamma in cell culture supernates, serum, and plasma. (TNF-alpha) and (INF-gamma) results are measured in pg/ml, elevated levels of circulating TNF-α \& IFN-gamma indicate that the case is deteriorating or progressing.

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

Study Arms (2)

G1 ( Conventional Physical Therapy Program group)

SHAM COMPARATOR

Patients in G1 underwent conventional physical therapy program continued for 3 months, included (aerobic training 20 minutes, resistive training for 15 minutes and flexibility program for 15 minutes). The whole treatment session lasted from 50 minutes to one hour, 3 times per week for 3 consecutive months.

Other: Conventional physical therapy program

G2 ( Computer-based Cognitive Therapy group)

ACTIVE COMPARATOR

Patients in G2 underwent Computer-based cognitive training continued for 3 months, included (attention/concentration, memory and reaction behavior training). The whole treatment session timing lasted 50 minutes to one hour, 3 times per week for 3 consecutive months.

Device: "RehaCom" computer-based cognitive training in addition to Conventional physical therapy program; Other: Conventional physical therapy program

Interventions

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

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.

G2 ( Computer-based Cognitive Therapy group)

Conventional physical therapy program OTHER

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

G1 ( Conventional Physical Therapy Program group); G2 ( Computer-based Cognitive Therapy group)

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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 .

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of physical therapy, Cairo University

Giza, Dokki, 11432, Egypt

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Moshera H Darwish, PhD

  Cairo University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Sealed Envelopes
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of P.T for neuromuscular disorders and its surgery

Model Details: A Single Blinded, Randomized Controlled Trial

Study Record Dates

• First Submitted: June 12, 2021
• First Posted: August 12, 2021
• Study Start: December 21, 2020
• Primary Completion: May 18, 2021
• Study Completion: June 7, 2021
• Last Updated: January 18, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)