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Integrative Group-based Cognitive Rehabilitation Efficacy in Multiple Sclerosis

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
cognitive remediation program: REHACOP
Sponsored by
University of Deusto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Multiple Sclerosis, cognitive rehabilitation, REHACOP

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

i) age 20-60 years

ii) either male or female

iii) patients with relapsing-remitting, secondary progressive or primary progressive MS

Exclusion criteria:

i) presence of dementia

ii) have suffered an exacerbation during the previous month to the cognitive assessment

iii) being treated with corticosteroids

iv) presence of other neurological disorder

v) history of stroke or traumatic brain injury resulting in more than 30 minutes loss of consciousness

vi) presence of psychiatric disorders

Sites / Locations

  • University of Deusto

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Cognitive remediation program: REHACOP

Control group

Arm Description

Cognitive rehabilitation program (REHACOP) including intervention in: attention, memory, processing speed, language, executive functioning and social cognition during 3 months, 3 times per week

No intervention was administered.

Outcomes

Primary Outcome Measures

Change in attention after receiving cognitive rehabilitation treatment
Attention was measured using the Brief Test of Attention (BTA).
Change in working memory after receiving cognitive remediation treatment
Working memory was measured using the Backward Digits (BD) subtest of the Wechsler Adult Intelligence Scale III.
Change in processing speed after receiving cognitive remediation treatment
Processing speed was measured using a composite score which included the Symbol Digit Modalities Test (SDMT), the three and six letter version of the Salthouse Perceptual Comparison Test (PCT) and the Trail Making Test A (TMTA).
Change in verbal memory after receiving cognitive remediation treatment
Verbal memory was measured using The Hopkins Verbal Learning Test - Revised (HVLT-R).
Change in verbal fluency after receiving cognitive remediation treatment
Verbal fluency was measured using the Calibrated Ideational Fluency Assessment (CIFA).
Change in executive functioning after receiving cognitive remediation treatment.
Executive functioning was measured with the Stroop Color-Word Test.

Secondary Outcome Measures

Full Information

First Posted
October 22, 2014
Last Updated
November 8, 2017
Sponsor
University of Deusto
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1. Study Identification

Unique Protocol Identification Number
NCT02287454
Brief Title
Integrative Group-based Cognitive Rehabilitation Efficacy in Multiple Sclerosis
Official Title
Integrative Group-based Cognitive Rehabilitation Efficacy in Multiple Sclerosis: a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Deusto

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The study design was a parallel-group randomized trial with equal randomization. Recruitment and enrollment were conducted between January 2013 and March 2013. At base-line, cognitive data was collected. Afterwards, the participants were randomly allocated to either the REHACOP group or the Control group. During 3 months the intervention with REHACOP program took place and at follow-up patients were again re-evaluated to evaluate the change in cognitive measure. Post-treatment assessment (finished by July 2013) was performed within the first week after completing the intervention. Optional enrollment in pre-post neuroimaging will also allow us to look at changes in the brain. Objective: To examine the efficacy of an integrative cognitive training program (REHACOP) to improve cognition of patients with Multiple Sclerosis (MS).
Detailed Description
Assessment protocol: Patients underwent an extensive neuropsychological battery including test of attention, working memory, processing speed, verbal memory (learning and recall), verbal fluency and executive functioning. Sustained attention was measured using the Brief Test of Attention. For working memory, the Backward Digits subtest of the Weschler Adult Intelligence Scale III was used. Processing speed was assessed through the Symbol Digit Modalities Test, the three and six letter version of the Salthouse Perceptual Comparison Test and the Trail Making Test A. Verbal memory was determined based on the Hopkins Verbal Learning Test , learning and long-term recall performance. For verbal fluency, the Category (animals and supermarket) and Letter (P) Word Fluency Test from the Calibrated Ideational Fluency Assessment were utilized . Executive functioning was calculated by the word-color and interference scores of the Stroop Word-Color Test. Additionally, several test and scales were administered. The Expanded Disability Status Scale was used for rating the degree of neurologic impairment. Premorbid IQ was tested by The Accentuation Reading Test. Cognitive reserve was estimated with the Cognitive Reserve Questionnaire. The 15-item Geriatric Depression Scale was included to assess patients´ depressive symptoms. The Fatigue Severity Scale and the mental fatigue Visual Analogue Scale were included to evaluate physical and mental fatigue, respectively. Description of the intervention: REHACOP is a structured program using paper-pencil tasks and it is based on the principles of restoration, compensation and optimization with a gradually increasing level of cognitive effort and demand. REHACOP trains different cognitive domains, such as attention, memory, processing speed, language, executive functioning and social cognition. Additionally, the program includes one unit related to functional outcome: activities of daily living. REHACOP includes up to 300 different tasks hierarchically organized into at least three levels of difficulty and subtypes of abilities. Several tasks are timed, so processing speed is trained throughout various modules. Once a basic cognitive strategy has been trained and well acquired, the therapist transitions the program to the next level. The program format allows for either individual or group sessions (between 5 and 8 patients per group), although for the purpose of this study, group sessions were chosen. In this study, two psychologists conducted the REHACOP group attending 60-minute-long sessions 3 days per week at Multiple Sclerosis Association of Biscay (ADEMBI) (four groups). Specifically, REHACOP group remediation with MS patients consisted of: Attention unit (4 weeks) training sustained, selective, alternant and divided attention; Memory unit (3 weeks) focusing on visual and verbal learning, recall and recognizing memory, as well as in working memory; Language unit (3 weeks) including verbal fluency, grammar, syntax, vocabulary, verbal comprehension, abstract language; Executive functions unit (2 weeks) training development, planning and attainment of objectives; and Social cognition unit (1 week) exercising theory of mind, social reasoning and moral dilemmas.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Multiple Sclerosis, cognitive rehabilitation, REHACOP

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive remediation program: REHACOP
Arm Type
Experimental
Arm Description
Cognitive rehabilitation program (REHACOP) including intervention in: attention, memory, processing speed, language, executive functioning and social cognition during 3 months, 3 times per week
Arm Title
Control group
Arm Type
No Intervention
Arm Description
No intervention was administered.
Intervention Type
Other
Intervention Name(s)
cognitive remediation program: REHACOP
Intervention Description
Specifically, REHACOP group remediation with MS patients consisted of: four weeks training attention (sustained, selective, alternating and divided attention); three weeks focused on learning and memory (the stimulation of verbal and visual memory was combined with learning and compensatory strategies, working memory was also trained); three weeks exercising executive functioning (development, planning and attainment of objectives); three weeks focused on language (verbal fluency, syntax, grammar, vocabulary and comprehension); and one week training social cognition (social reasoning, theory of mind and moral dilemmas).
Primary Outcome Measure Information:
Title
Change in attention after receiving cognitive rehabilitation treatment
Description
Attention was measured using the Brief Test of Attention (BTA).
Time Frame
3 months
Title
Change in working memory after receiving cognitive remediation treatment
Description
Working memory was measured using the Backward Digits (BD) subtest of the Wechsler Adult Intelligence Scale III.
Time Frame
3 months
Title
Change in processing speed after receiving cognitive remediation treatment
Description
Processing speed was measured using a composite score which included the Symbol Digit Modalities Test (SDMT), the three and six letter version of the Salthouse Perceptual Comparison Test (PCT) and the Trail Making Test A (TMTA).
Time Frame
3 months
Title
Change in verbal memory after receiving cognitive remediation treatment
Description
Verbal memory was measured using The Hopkins Verbal Learning Test - Revised (HVLT-R).
Time Frame
3 months
Title
Change in verbal fluency after receiving cognitive remediation treatment
Description
Verbal fluency was measured using the Calibrated Ideational Fluency Assessment (CIFA).
Time Frame
3 months
Title
Change in executive functioning after receiving cognitive remediation treatment.
Description
Executive functioning was measured with the Stroop Color-Word Test.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: i) age 20-60 years ii) either male or female iii) patients with relapsing-remitting, secondary progressive or primary progressive MS Exclusion criteria: i) presence of dementia ii) have suffered an exacerbation during the previous month to the cognitive assessment iii) being treated with corticosteroids iv) presence of other neurological disorder v) history of stroke or traumatic brain injury resulting in more than 30 minutes loss of consciousness vi) presence of psychiatric disorders
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Naroa Ibarretxe-Bilbao, Doctor
Organizational Affiliation
University of Deusto
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Deusto
City
Bilbao
State/Province
Biskai
ZIP/Postal Code
48007
Country
Spain

12. IPD Sharing Statement

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Integrative Group-based Cognitive Rehabilitation Efficacy in Multiple Sclerosis

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