Multiple SclerosisNCT02287454
Integrative Group-based Cognitive Rehabilitation Efficacy in Multiple Sclerosis
A study testing cognitive remediation program: REHACOP in people with Multiple Sclerosis, run by University of Deusto at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- cognitive remediation program: REHACOP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2013to Jul 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- age 20-60 years
- either male or female
- patients with relapsing-remitting, secondary progressive or primary progressive MS
Who cannot join
- presence of dementia
- have suffered an exacerbation during the previous month to the cognitive assessment
- being treated with corticosteroids
- presence of other neurological disorder
- history of stroke or traumatic brain injury resulting in more than 30 minutes loss of consciousness
- presence of psychiatric disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Integrative Group-based Cognitive Rehabilitation Efficacy in Multiple Sclerosis: a Randomized Clinical Trial
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).
Read the 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.
- Conditions
- Multiple Sclerosis
- Being tested
- cognitive remediation program: REHACOP
- Keywords
- Multiple Sclerosis, cognitive rehabilitation, REHACOP
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive remediation program: REHACOPOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Cognitive remediation program: REHACOP | Experimental | Cognitive rehabilitation program (REHACOP) including intervention in: attention, memory, processing speed, language, executive functioning and social cognition during 3 months, 3 times per week Receives: Other: cognitive remediation program: REHACOP |
| Control group | No intervention | No intervention was administered. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in attention after receiving cognitive rehabilitation treatment
Attention was measured using the Brief Test of Attention (BTA).
Measured: 3 months
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.
Measured: 3 months
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).
Measured: 3 months
Change in verbal memory after receiving cognitive remediation treatment
Verbal memory was measured using The Hopkins Verbal Learning Test - Revised (HVLT-R).
Measured: 3 months
Change in verbal fluency after receiving cognitive remediation treatment
Verbal fluency was measured using the Calibrated Ideational Fluency Assessment (CIFA).
Measured: 3 months
Change in executive functioning after receiving cognitive remediation treatment.
Executive functioning was measured with the Stroop Color-Word Test.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2014 (estimated)
- Study startJan 2013
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Deusto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Naroa Ibarretxe-Bilbao, Doctor, Principal investigator, University of Deusto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02287454
- Sponsor's protocol ID
- NSMC-002-UD
- Status last verified
- Nov 2017
- First submitted
- 22 Oct 2014
- Last updated
- 13 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrative Group-based Cognitive Rehabilitation Efficacy in Multiple Sclerosis: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02287454
- Acronym / sponsor ID
- NSMC-002-UD
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, cognitive rehabilitation, REHACOP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of DeustoUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 10 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive remediation program: REHACOP | Experimental | Other: cognitive remediation program: REHACOPCognitive rehabilitation program (REHACOP) including intervention in: attention, memory, processing speed, language, executive functioning and social cognition during 3 months, 3 times per week |
| Control group | No intervention | –No intervention was administered. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- age 20-60 years
- either male or female
- patients with relapsing-remitting, secondary progressive or primary progressive MS
Key exclusion criteria (6 listed)
- presence of dementia
- have suffered an exacerbation during the previous month to the cognitive assessment
- being treated with corticosteroids
- presence of other neurological disorder
- history of stroke or traumatic brain injury resulting in more than 30 minutes loss of consciousness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cognitive remediation program: REHACOPSpecifically, 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). | Other | Cognitive remediation program: REHACOP |
Primary outcome
Change in attention after receiving cognitive rehabilitation treatment
Time frame: 3 months
Attention was measured using the Brief Test of Attention (BTA).
Change in working memory after receiving cognitive remediation treatment
Time frame: 3 months
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
Time frame: 3 months
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
Time frame: 3 months
Verbal memory was measured using The Hopkins Verbal Learning Test - Revised (HVLT-R).
Change in verbal fluency after receiving cognitive remediation treatment
Time frame: 3 months
Verbal fluency was measured using the Calibrated Ideational Fluency Assessment (CIFA).
Change in executive functioning after receiving cognitive remediation treatment.
Time frame: 3 months
Executive functioning was measured with the Stroop Color-Word Test.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Naroa Ibarretxe-Bilbao, Doctor principal investigator
University of Deusto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cognitive remediation program: REHACOP in people with Multiple Sclerosis, run by University of Deusto at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in attention after receiving cognitive rehabilitation treatment (time frame: 3 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2017.