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临床试验/NCT02287454
NCT02287454已完成不适用

Integrative Group-based Cognitive Rehabilitation Efficacy in Multiple Sclerosis: a Randomized Clinical Trial

University of Deusto1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2013年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
32
试验地点
1
主要终点
Change in working memory after receiving cognitive remediation treatment

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •i) age 20-60 years
  • •ii) either male or female
  • •iii) patients with relapsing-remitting, secondary progressive or primary progressive MS

排除标准

  • •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

研究组 & 干预措施

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

干预措施: cognitive remediation program: REHACOP (Other)

Control group

No Intervention

No intervention was administered.

结局指标

主要结局

Change in working memory after receiving cognitive remediation treatment

时间窗: 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

时间窗: 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

时间窗: 3 months

Verbal memory was measured using The Hopkins Verbal Learning Test - Revised (HVLT-R).

Change in verbal fluency after receiving cognitive remediation treatment

时间窗: 3 months

Verbal fluency was measured using the Calibrated Ideational Fluency Assessment (CIFA).

Change in attention after receiving cognitive rehabilitation treatment

时间窗: 3 months

Attention was measured using the Brief Test of Attention (BTA).

Change in executive functioning after receiving cognitive remediation treatment.

时间窗: 3 months

Executive functioning was measured with the Stroop Color-Word Test.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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