Effectiveness and Cost-Effectiveness of Cognitive Stimulation Therapy - Spain (CST-ES) in People Living With Dementia

NCT06372002 | Active Not Recruiting

• 1 other identifier: 05/23
• Study Type: interventional
• Target: 683
• Locations: 1 country
• Sites: 46

Brief Summary

This study aims to evaluate the effectiveness and cost-effectiveness of CST-ES, the Spanish adaptation of Cognitive Stimulation Therapy (CST), to improve cognition and quality of life in people with mild to moderate dementia. The evaluation will be conducted as a pragmatic multicenter randomized controlled clinical trial. Participants will be randomized to receive 7 weeks of CST-ES followed by 24 weeks of maintenance CST-ES (intervention group) or to continue their usual treatment (control group).

Conditions

Dementia; Neurocognitive Disorders; Mild Cognitive Impairment

Keywords

Dementia; Neurocognitive Disorders; Mild Cognitive Impairment; Cognitive stimulation; cognition; quality of life; neuropsychiatric symptoms; older adult; cognition oriented treatment; cost-effectiveness

Outcome Measures

Primary Outcomes (6)

• Cognitive functioning assessed through Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-COG)

  The ADAS-Cog scale will be used, a test designed to assess cognition in people with AD. The ADAS-Cog takes approximately 30-40 minutes to complete and includes eleven tests that assess word recall, object and finger naming, verbal command comprehension, constructive praxis, ideational praxis, word recognition, expressive language, comprehension, and word finding difficulties. The maximum score is 70 points, and higher scores indicate greater severity of cognitive deficits. Due to its psychometric properties, it has been widely used in clinical pharmacological trials for AD to assess cognitive change throughout time.

  Baseline (T0)

• Change in cognitive functioning assessed through Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-COG)

  The ADAS-Cog scale will be used, a test designed to assess cognition in people with AD. The ADAS-Cog takes approximately 30-40 minutes to complete and includes eleven tests that assess word recall, object and finger naming, verbal command comprehension, constructive praxis, ideational praxis, word recognition, expressive language, comprehension, and word finding difficulties. The maximum score is 70 points, and higher scores indicate greater severity of cognitive deficits. Due to its psychometric properties, it has been widely used in clinical pharmacological trials for AD to assess cognitive change throughout time.

  7 weeks after the start of the CST-ES program (First follow-up T1)

• Change in cognitive functioning assessed through Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-COG)

  The ADAS-Cog scale will be used, a test designed to assess cognition in people with AD. The ADAS-Cog takes approximately 30-40 minutes to complete and includes eleven tests that assess word recall, object and finger naming, verbal command comprehension, constructive praxis, ideational praxis, word recognition, expressive language, comprehension, and word finding difficulties. The maximum score is 70 points, and higher scores indicate greater severity of cognitive deficits. Due to its psychometric properties, it has been widely used in clinical pharmacological trials for AD to assess cognitive change throughout time.

  24 weeks after the start of CST-ES maintenance program (second follow-up and endpoint assessment, T2)

• Quality of life evaluated through Quality of Life - Alzheimer's Disease (QoL-AD)

  Quality of Life - Alzheimer's Disease (QoL-AD). QoL-AD is used to assess quality of life in people with dementia, based on the information provided by the patient (patient version). It consists of 13 items referring to perceived health status, mood, functional capacity, personal and leisure relationships, capacity to decide, and personal life as a whole. Each item is answered on a Likert-type scale from 1 (poor) to 4 (excellent). The score range from 13-52. Higher scores indicate better quality of life. This tool has good psychometric properties, and its use has been recommended by a European consensus to assess psychosocial interventions. The Spanish adaptation of this scale will be used.

  Baseline (T0)

• Change in Quality of life evaluated through Quality of Life - Alzheimer's Disease (QoL-AD)

  Quality of Life - Alzheimer's Disease (QoL-AD). QoL-AD is used to assess quality of life in people with dementia, based on the information provided by the patient (patient version). It consists of 13 items referring to perceived health status, mood, functional capacity, personal and leisure relationships, capacity to decide, and personal life as a whole. Each item is answered on a Likert-type scale from 1 (poor) to 4 (excellent). The score range from 13-52. Higher scores indicate better quality of life. This tool has good psychometric properties, and its use has been recommended by a European consensus to assess psychosocial interventions. The Spanish adaptation of this scale will be used.

  7 weeks after the start of the CST-ES program (First follow-up T1)

• Change in Quality of life evaluated through Quality of Life - Alzheimer's Disease (QoL-AD)

  Quality of Life - Alzheimer's Disease (QoL-AD). QoL-AD is used to assess quality of life in people with dementia, based on the information provided by the patient (patient version). It consists of 13 items referring to perceived health status, mood, functional capacity, personal and leisure relationships, capacity to decide, and personal life as a whole. Each item is answered on a Likert-type scale from 1 (poor) to 4 (excellent). The score range from 13-52. Higher scores indicate better quality of life. This tool has good psychometric properties, and its use has been recommended by a European consensus to assess psychosocial interventions. The Spanish adaptation of this scale will be used.

  24 weeks after the start of CST-ES maintenance program (second follow-up and endpoint assessment, T2)

Secondary Outcomes (6)

• Cognitive functioning assessed through Mini-Mental State Examination (MMSE)

  Baseline (T0)

• Change in Cognitive functioning assessed through Mini-Mental State Examination (MMSE)

  7 weeks after the start of the CST-ES program (First follow-up T1)

• Change in Cognitive functioning assessed through Mini-Mental State Examination (MMSE)

  24 weeks after the start of CST-ES maintenance program (second follow-up and endpoint assessment, T2)

• Quality of life evaluated through EuroQol-5D 5-level version (EQ-5D-5L)

  Baseline (T0)

• Change in Quality of life evaluated through EuroQol-5D 5-level version (EQ-5D-5L)

  7 weeks after the start of the CST-ES program (First follow-up T1)

Other Outcomes (4)

• Resource utilization evaluated through Resource Utilization in Dementia (RUD)

  Baseline (T0)

• Change in resource utilization evaluated through Resource Utilization in Dementia (RUD)

  24 weeks after the start of CST-ES maintenance program (second follow-up and endpoint assessment, T2)

• Sociodemographic information gathered through the sociodemographic questionnaire

  Baseline (T0)

Study Arms (2)

Cognitive Stimulation Therapy

EXPERIMENTAL

Participants assigned to the intervention group will undergo 14 CST sessions, twice a week, for 7 weeks, in addition to continuing their standard care. Participants will then receive the CST Maintenance program, which consists of 24 sessions, once a week for 24 weeks, in addition to continuing their standard care.

Behavioral: Cognitive Stimulation Therapy (CST)

Control

NO INTERVENTION

Participants in the control group will maintain their standard care, participating in those activities previously assigned in their individual care plan.

Interventions

Cognitive Stimulation Therapy (CST) BEHAVIORAL

The intervention will consist of the Spanish adapted version of Cognitive Stimulation Therapy (CST) followed by the Maintenance CST program. CST is a cognitive intervention for treating mild to moderate dementia consisting of fourteen 45-minute group sessions that take place twice a week for 7 weeks. Each session follows a main topic (reminiscing about the person's life, current events, word games…) and is led by two group facilitators. The same structure is followed in every CST session: 1. Introduction (5 minutes). 2. Main Activity (25 minutes). 3. Closing (5 minutes). The Maintenance CST program follows the principles and structure of the original CST program and consists of 24 sessions, one per week, that will be administered after the original program. The topic, activities, and materials required for each session are specified in the CST-ES manuals, which also provide the key principles that should guide the intervention and other information necessary for its implementation.

Also known as: Maintenance CST (mCST), Cognitive Stimulation Therapy España (CST-ES), Cognitive Stimulation Therapy España de mantenimiento (mCST-ES)

Cognitive Stimulation Therapy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Users of any of the sites (Associations of Families of People with Dementia) participating in the study.
• Individuals with a clinical diagnosis of neurocognitive disorder according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5; APA, 2013), including Alzheimer's Disease (AD), Vascular Dementia (VD), mixed dementia (MxD), Lewy Body Dementia (LBD), Frontotemporal Dementia (FTD), Mild cognitive impairment or dementia due to Parkinson's disease (PD).
• Mild cognitive impairment or mild to moderate dementia (MMSE greater than 10).
• People who can be able to communicate and understand enough to participate in group activities.
• People who can participate in a group activity for at least 45 minutes.
• Signing of informed consent by the person with dementia or the legal guardian.

You may not qualify if:

• Presence of sensory limitations that prevent participation in the sessions.
• Health problems that prevent or hinder their participation in the sessions.

Sponsors & Collaborators

• Instituto de Mayores y Servicios Sociales (IMSERSO): lead
• University of Castilla-La Mancha: collaborator
• Confederación Española de Alzheimer (CEAFA): collaborator

Study Sites (46)

Centro de día de la Asociación de Familiares y Amigos de Enfermos de Alzheimer de Alcoy y Comarca

Alcoy, Alicante, Spain

Location

AFA Castalla y Onil

Castalla, Alicante, Spain

Location

AFA Elda, Petrer y Comarca del Medio Vinalopo

Elda, Alicante, Spain

Location

AFA Teulada - Moraira (Marina Alta)

Teulada, Alicante, Spain

Location

Asociación Familiares de Personas con Alzheimer de Villena y Comarca

Villena, Alicante, Spain

Location

Centro Terapéutico para Alzheimer y otras demencias "Antonia Blanco Sánchez"

Mérida, Badajoz, Spain

Location

AFAMA Pollença

Pollença, Balearic Islands, Spain

Location

Centro Alois II

Cornellà de Llobregat, Barcelona, Spain

Location

Asociación de familiares de personas con Alzheimer y otras demencias del Maresme

Mataró, Barcelona, Spain

Location

Asociación de Familiares de Enfermos de Alzheimer de Iniesta (ADADI)

Iniesta, Cuenca, Spain

Location

AFEAVA

Hervás, Cáceres, Spain

Location

AFA Faro de Chipiona

Chipiona, Cádiz, Spain

Location

Afa Puerto

El Puerto de Santa María, Cádiz, Spain

Location

Asoc familiares de enfermos de Alzheimer y otras demencias afines de Fernán Núñez

Fernán Núñez, Córdoba, Spain

Location

AFAMO

Montilla, Córdoba, Spain

Location

AFASUR Genil

Puente-Genil, Córdoba, Spain

Location

Asociación de familiares de enfermos de Alzheimer de Motril - Contigo

Motril, Granada, Spain

Location

Asociación Alzheimer Bierzo

Ponferrada, León, Spain

Location

Afa Santa Marina Del Rey

Santa Marina del Rey, León, Spain

Location

Associació de Familiars i Malalts d'Alzheimer de Tàrrega i comarca

Tàrrega, Lleida, Spain

Location

AFA Pozuelo

Pozuelo de Alarcón, Madrid, Spain

Location

Asociación Alzheimer y otras Demencias Lorca

Lorca, Murcia, Spain

Location

Centro de día Alzheimer Estepona

Estepona, Málaga, Spain

Location

Centro de Día Nieves Barranco

Marbella, Málaga, Spain

Location

AFADAX

Vélez-Málaga, Málaga, Spain

Location

Asociación de Alzheimer "Virgen del Castillo"

Lebrija, Sevilla, Spain

Location

AFATA Asociación de familiares y amigos de personas con deterioro cognitivo, enfermedad de Alzheimer y otras demencias de Talavera de la Reina

Talavera de la Reina, Toledo, Spain

Location

ASFAL (Asociación de Familiares y Amigos de personas con Alzheimer de Algemesí)

Algemesí, Valencia, Spain

Location

AFA Alginet

Alginet, Valencia, Spain

Location

Centro de estimulación y Rehabilitación "La LLimera" de AFABALS

Benifaió, Valencia, Spain

Location

AFA Benavente y Comarca

Benavente, Zamora, Spain

Location

AFA Alicante

Alicante, Spain

Location

Alzheimer Ávila

Ávila, Spain

Location

Centre de Día AFA Barcelona

Barcelona, Spain

Location

AFA Alzhe de Cadiz

Cadiz, Spain

Location

Club de la memoria - Alzhei Cáceres

Cáceres, Spain

Location

Asociación San Rafael de Alzheimer y Otras Demencias

Córdoba, Spain

Location

AFA Huelva

Huelva, Spain

Location

Alzheimer León

León, Spain

Location

Asociación de Familiares y Enfermos de Alzheimer y otras demencias de La Rioja (AFA Rioja)

Logroño, Spain

Location

AFALU

Lugo, Spain

Location

AFA Málaga

Málaga, Spain

Location

Centro de Referencia estatal de atención a personas con enfermedad de Alzheimer y otras demencias - Imserso

Salamanca, 37008, Spain

Location

AGADEA

Santiago de Compostela, Spain

Location

AFAV (Asociación Familiares Enfermos de Alzheimer Valencia)

Valencia, Spain

Location

AFARABA

Vitoria-Gasteiz, Álava, Spain

Location

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MeSH Terms

Conditions

Dementia; Neurocognitive Disorders; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Cognition Disorders

Study Officials

• Enrique Pérez-Sáez, Phd

  CRE de atención a personas con enfermedad de Alzheimer y otras demencias - Imserso

  STUDY DIRECTOR

• Luz María Peña Longobardo, Phd

  University of Castilla-La Mancha

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The technician in charge of the evaluation of those participating in the study must be blinded throughout the CST intervention, i.e., he/she will not know whether the users being evaluated belong to the intervention or the control group. The CRE Alzheimer professional responsible for randomization and data analysis will also be blinded. The participants and the technician performing the intervention cannot be blinded due to the nature of the intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neuropsychologist

Model Details: A pragmatic, multicenter, randomized, controlled clinical trial is proposed to compare treatment with CST-ES followed by maintenance treatment with CST-ES with treatment as usual: * First Phase: Participants who meet the inclusion criteria will be randomized to the CST-ES intervention group or a treatment-as-usual control group. Participants assigned to the intervention group will receive two sessions of CST-ES per week for 7 weeks, also they will continue their usual treatment. Participants in the control group will receive their usual treatment during the development of the study. * Second Phase: After the first phase is completed, participants assigned to the intervention group will receive one session of maintenance CST-ES per week for 24 weeks besides continuing their usual treatment, whereas participants in the control group will continue their usual treatment during this second phase.

Study Record Dates

• First Submitted: April 11, 2024
• First Posted: April 17, 2024
• Study Start: October 16, 2023
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: April 17, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (46)