Comprehensive Cognitive Remediation as a Strategy to Prevent Cognitive Impairment Associated With Age and Disability With the REHACOP Program

NCT03435029 | Completed DMC

• 1 other identifier: NSMC-004-UD
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Aging

Keywords

aging; cognitive rehabilitation; REHACOP

Outcome Measures

Primary Outcomes (1)

• Change from baseline to post-treatment and follow-up on one final neurocognition composite score after receiving cognitive remediation.

  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.

  3 months and 12 months follow-up

Secondary Outcomes (6)

• Change from baseline score to post-treatment and follow-up on Geriatric Depression Scale (GDS)

  3 months and 12 month follow-up

• Change from baseline score to post-treatment and follow-up on Neuropsychiatric Inventory Questionnaire (NPI-Q)

  3 months and 12 months follow-up

• Change from baseline score to post-treatment and follow-up on Lille Apathy Rating Scale (LARS)

  3 months and 12 months follow-up

• Change from baseline score to post-treatment and follow-up on Multidimensional Fatigue Inventory (MFI)

  3 months and 12 months follow-up

• Change from baseline score to post-treatment and follow-up on Satisfaction With Life Scale (SWLS)

  3 months and 12 months follow-up

Study Arms (2)

Cognitive Remediation Program (REHACOP)

EXPERIMENTAL

The cognitive rehabilitation program (REHACOP) is a 5 month intervention that allows both individual and group intervention. For the purpose of this study, we included intervention in several domains: attention, language, memory, processing speed, and executive functioning for 3 months, 3 times per week, in 60 minute per session.

Behavioral: Cognitive Remediation Program (REHACOP)

Occupational Therapy

ACTIVE COMPARATOR

The control group performed of occupational group activities (memory tasks, reading the newspaper, drawing, singing or doing crafts). These activities were accomplished in a group format and with the same frequency as the implementation of REHACOP in the experimental group.

Other: Occupational Therapy

Interventions

Cognitive Remediation Program (REHACOP) BEHAVIORAL

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.

Cognitive Remediation Program (REHACOP)

Occupational Therapy OTHER

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.

Occupational Therapy

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age over 55 years
• signing informed consent
• independence in daily living activities

You may not qualify if:

• history of neurological or psychiatric conditions, Neuropsychiatric Inventory Cummings \> 4
• illiterate
• Mini Mental State Examination \< 20
• severe physical constraints.

Sponsors & Collaborators

• University of Deusto: lead

Study Sites (1)

University of Deusto

Bilbao, Bizcay, 48007, Spain

Location

Related Publications (1)

• Montoya-Murillo G, Ibarretxe-Bilbao N, Pena J, Ojeda N. Effects of Cognitive Rehabilitation on Cognition, Apathy, Quality of Life, and Subjective Complaints in the Elderly: A Randomized Controlled Trial. Am J Geriatr Psychiatry. 2020 May;28(5):518-529. doi: 10.1016/j.jagp.2019.10.011. Epub 2019 Oct 21.

  PMID: 31735487 DERIVED

MeSH Terms

Interventions

Occupational Therapy

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics

Study Officials

• Natalia Ojeda del Pozo, PhD

  University of Deusto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2018
• First Posted: February 15, 2018
• Study Start: September 1, 2012
• Primary Completion: February 1, 2017
• Study Completion: March 1, 2018
• Last Updated: July 18, 2019

Record last verified: 2019-07

Locations

ES (1)