University of Deusto
Bilbao, Bizcay, 48007, Spain
NCT Number: NCT03435029
The aim of the study was to analyze the effectiveness of a comprehensive cognitive remediation program (REHACOP) in the non demented elderly, obtaining improvements in cognition and functional skills. It was a longitudinal randomized controlled trial with three assessments: basal, post-treatment, and 12-month follow-up.
Recruitment and enrollment were conducted between September 2012 and November 2016. All participants underwent a clinical interview and an extensive neuropsychological battery. Patients were randomized in an experimental and a control group. The groups were formed by a maximum of eight participants run by an experienced therapist. The experimental group received cognitive remediation for 3 months, 3 times per week, 60 minutes per session. The control group consisted of occupational group activities (reading the newspaper, drawing, singing or doing crafts) with the same frequency as the experimental group. Post-treatment assessment was carried out within the first week after completing the intervention. Finally, longitudinal follow-up at 12 months with neuropsychological assessments will be performed.
Objective: To examine the efficacy of a comprehensive cognitive training program (REHACOP) to improve cognition, clinical symptoms and functional disability for the elderly.
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Notify Me55 year and older
All sexes
Interventional
Not applicable
Bilbao, Bizcay, 48007, Spain
Premorbid IQ was tested by the following tests:
Cognitive status was tested by the following tests:
Neurocognitive status was tested by the following tests:
In order to create a neurocognition composite score, all raw scores were converted to z-scores. The neurocognition composite score was based on the following test and subtest included in the protocol, that is: BTA total score, total score of the forward digits and total score of the backward digit of the WAIS-III, total number of word beginning with the letter "p" in three minutes and total number of words for animals and supermarket categories in one minute of the CIFA, total score of learning and total score of long-term recall of the HVLT-R, total score of learning and total score of long-term recall of the BVMT-R, total score of the free drawing of the CDT, total score of letters and total score of the cube analysis of the VOSP, time of the TMT-A, total score of the SPCT, and total score of the word-color trial of the Stroop Test.
All raw scores were converted to z-scores. TMT-A score was adjusted so that higher scores indicated better cognitive performance. The z-scores were pooled into composite score with the average of the tests and subtest mentioned above.
Clinical variables, functional variables and subjective complaints were measured by the following tests. Raw scores were used in order to facilitate clinical interpretation.
REHACOP is a comprehensive cognitive remediation program structured in cognitive domains and three levels of difficulty. It is theoretically based on strategies of cognitive rehabilitation (restoration, compensation and optimization). REHACOP uses mainly a bottom-up approach in such a way that it begins with the simplest cognitive domains and ends with the most complex domains and top-down strategies to help with generalization of abilities in daily life. It contains more than 300 paper and pencil tasks, hierarchically structured in 4 modules of cognition (attention and concentration, learning and memory, language and executive functioning), 3 modules of functionality (social cognition, social skills and activities of daily living) and a module of psychoeducation. In this study we used a modified version of REHACOP for the elderly. The REHACOP group received cognitive remediation sessions 3 times per week for 3 months 60 minutes per session. The remediation sessions were performed in the actual homes for the elderly. The groups were made up of a maximum of 8 participants. In particular, the rehabilitation of the REHACOP group consisted of 39 sessions divided into: attention and concentration unit (sustained, selective, alternating, and divided attention) 4 weeks; learning and memory unit (verbal and visual memory and learning strategies) 3 weeks; language (verbal fluency, syntax, grammar, vocabulary, and comprehension) 3 weeks; executive functioning (objectives planning and attainment, verbal reasoning, categorization, and conceptualization) and processing speed were trained transversely during the sessions. This study did not apply the remaining modules (social cognition, social skills, daily living activities and psychoeducation).
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The REHACOP group received cognitive remediation sessions 3 times per week for 3 months in 60 minute per session. The rehabilitation consisted of 39 sessions divided into: attention and concentration unit (sustained, selective, alternating, and divided attention) 4 weeks; learning and memory unit (verbal and visual memory and learning strategies) 3 weeks; language (verbal fluency, syntax, grammar, vocabulary, and comprehension) 3 weeks; and executive functioning (objectives planning and attainment, verbal reasoning, categorization, and conceptualization). In addition, processing speed was trained transversely during all the sessions.
The control group received occupational group activities (reading the newspaper, drawing, singing or doing crafts) with the same frequency and format as the experimental group.
Time frame: 3 months and 12 months follow-up
The neurocognition composite score is one z score that was based on the following test: BTA total score, total score of the forward digits and backward digit of the WAIS-III, total number of words beginning with the letter "p" in 3-minute and total number of words for animals and supermarket categories in 1-minute of the CIFA, total score of learning and total score of long-term recall of the HVLT-R, total score of learning and long-term recall of the BVMT-R, total score of the free drawing of the CDT, total score of letters and total score of the cube analysis of the VOSP, time of the TMT-A, total score of the SPCT, and total score of the word-color trial of the Stroop Test. All raw scores were converted to z-scores. TMT-A score was adjusted so that higher scores indicated better performance. The z-scores were pooled into one composite score with the average of the primary measures mentioned above. Higher scores in this composite score indicated better performance.
Time frame: 3 months and 12 month follow-up
Geriatric Depression Scale (GDS-15) includes 15 items. Higher scores indicate a higher degree of depression (range from 0 to 15 points).
Time frame: 3 months and 12 months follow-up
Neuropsychiatric Inventory Questionnaire (NPI-Q) includes 10 neuropsychiatric (delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, euphoria, apathy, disinhibition, irritability, and aberrant motor behavior) domains assessed in terms of severity and frequency in a range from 0 to 120 points. Higher scores indicate greater neuropsychiatric behaviors.
Time frame: 3 months and 12 months follow-up
Lille Apathy Rating Scale (LARS) is composed by 33 items, subdivided into 9 subscales (everyday productivity, interests, taking initiative, novelty seeking/motivation, emotional responses, concern, social life, and self-awareness). These subscales are summed into a total score with a possible range from -36 to 36 points. Lower scores indicate a higher degree of apathy.
Time frame: 3 months and 12 months follow-up
Multidimensional Fatigue Inventory (MFI) is composed by 20 items divided into 5 subscales (general index, physical fatigue, mental fatigue, lack of motivation, lack of activity). Higher scores indicate greater fatigue (range from 0 to 140 points).
Time frame: 3 months and 12 months follow-up
Satisfaction With Life Scale (SWLS). This scale is composed by 5 items. Higher scores indicate greater live satisfaction (range from 0 to 35 points)
Time frame: 3 months and 12 months follow-up
Subjective complains were assessed by Subjective Questionnaire on Cognitive and Functional Complains of the patient and caregivers. These questionnaires are composed by 40 items each one of them. Higher scores indicate greater subjective complains (range from 0 to 120 points).
University of Deusto
Other
Comprehensive Cognitive Remediation as a Strategy to Prevent Cognitive Impairment Associated With Age and Disability in the Elderly With the REHACOP Program
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