Effectiveness and Cost-Effectiveness of Cognitive Stimulation Therapy - Spain (CST-ES) in People Living With Dementia
NCT ID: NCT06372002
Last Updated: 2024-04-17
Study Results
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Basic Information
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ACTIVE_NOT_RECRUITING
NA
683 participants
INTERVENTIONAL
2023-10-16
2024-07-31
Brief Summary
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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).
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Detailed Description
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To improve the quality of life of patients with dementia and their families, a wide variety of non-pharmacological therapies (NPT) have been developed, making cognitive interventions one of the most widespread. Although in Spain the term cognitive stimulation is mostly used in a generic way that includes different intervention modalities, at a conceptual level three types of cognitive interventions have been described: cognitive stimulation, cognitive training, and cognitive rehabilitation. In summary, cognitive stimulation increases orientation and global cognitive status, whilst cognitive training aims to restore specific cognitive functions, and cognitive rehabilitation aims to preserve functionality in everyday contexts. Although distinguishing between these cognition-oriented interventions is not always easy, cognitive stimulation has probed the most efficacy, with significant benefits on cognitive function compared to those obtained with acetylcholinesterase inhibitors and positive effects on quality of life, well-being, communication, and social interaction.
Cognitive Stimulation Therapy (CST) is a cognitive intervention for mild to moderate dementia that was developed in the United Kingdom and derived from those therapies that had shown the most promising results, combining their most effective elements. The original CST program consists of 14 45-minute sessions delivered twice a week for 7 weeks. There is also a maintenance program that includes 24 additional sessions (one session per week). CST is thought to provide a positive environment, with continuity and consistency between sessions to support memories formation. Its key principles include person-centered attention, consideration of the interests and abilities of every participant, use of implicit rather than explicit learning, focusing on opinions rather than facts, stimulation of all senses and cognitive skills, and use of reminiscence to orientate in the present moment. CST focuses on the cognitive strengths of people with dementia, reducing the sense of failure and increasing their confidence. Positive reinforcement of questioning, thinking, and interacting can also lead to more positive self-evaluation, increased communication, and better use of cognitive skills in daily life.
A manual has been published with the original CST intervention (Making a Difference) and another with the maintenance program (Making a Difference 2), which includes the basic principles of the intervention, each of the sessions developed, details of the materials needed, and how to monitor the process.
CST has shown significant benefits in general cognitive function, as well as improvements in specific cognitive functions such as communication and language, memory, orientation, and praxis. The program has also been shown to improve the quality of life of the participants. In addition, CST is effective independent of acetylcholinesterase inhibitor treatment, and cognitive benefits are comparable to those obtained with this medication. CST is a relatively unexpensive and more cost-effective intervention than usual care. As a result of these findings, CST has been recommended by organizations such as Alzheimer's Disease International or the National Institute for Health and Clinical Excellence and the Social Care Institute for Excellence, translated and adapted into several languages, and offered in at least 35 countries.
Although there is a significant amount of cognitive stimulation materials available in Spain, none of the published programs has a level of evidence comparable to that of CST. Given the need for evidence-based tools and materials to respond to the needs of people with dementia, the National Reference Center for the Care of People with Alzheimer's Disease and Other Dementias (CREA) has undertaken a process of translation and cultural adaptation of the two published CST manuals to the Spanish language and culture (CST-ES). Once the adaptation is completed, a study protocol is developed to evaluate the effectiveness and cost-effectiveness of the CST-ES program to improve cognitive performance and quality of life in people with mild to moderate dementia. Afterward, a multicenter study will be conducted using a randomized clinical trial methodology.
Hypothesis
* After the 7 weeks of CST-ES, participants in the intervention group will improve their cognitive scores, whilst participants in the control group will either maintain or worsen their scores.
* Participants in the CST-ES group will improve their quality of life.
* Participants who continue with the CST-ES maintenance program will experience cognitive benefits compared to participants in the usual treatment control group.
* The CST-ES maintenance program will increase the quality-of-life benefits compared to the control group.
* Intervention with CST-ES and maintenance of CST-ES will be efficient compared to usual treatment.
Objectives
The main objectives of the study are:
• To compare the effectiveness of CST-ES intervention followed by maintenance CST-ES with usual treatment to improve cognition and quality of life in people with mild to moderate dementia.
The following is proposed as a secondary objective:
• Perform a cost-effectiveness and cost-utility analysis comparing the direct costs associated with CST-ES and usual treatment with the outcomes of the two alternatives.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
* 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.
TREATMENT
DOUBLE
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.
Study Groups
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Cognitive Stimulation Therapy
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.
Cognitive Stimulation Therapy (CST)
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.
Control
Participants in the control group will maintain their standard care, participating in those activities previously assigned in their individual care plan.
No interventions assigned to this group
Interventions
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Cognitive Stimulation Therapy (CST)
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* Health problems that prevent or hinder their participation in the sessions.
ALL
No
Sponsors
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University of Castilla-La Mancha
OTHER
Confederación Española de Alzheimer (CEAFA)
UNKNOWN
Instituto de Mayores y Servicios Sociales (IMSERSO)
OTHER_GOV
Responsible Party
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Enrique Perez Saez
Neuropsychologist
Principal Investigators
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Enrique Pérez-Sáez, Phd
Role: STUDY_DIRECTOR
CRE de atención a personas con enfermedad de Alzheimer y otras demencias - Imserso
Luz María Peña Longobardo, Phd
Role: PRINCIPAL_INVESTIGATOR
University of Castilla-La Mancha
Locations
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Centro de día de la Asociación de Familiares y Amigos de Enfermos de Alzheimer de Alcoy y Comarca
Alcoy, Alicante, Spain
AFA Castalla y Onil
Castalla, Alicante, Spain
AFA Elda, Petrer y Comarca del Medio Vinalopo
Elda, Alicante, Spain
AFA Teulada - Moraira (Marina Alta)
Teulada, Alicante, Spain
Asociación Familiares de Personas con Alzheimer de Villena y Comarca
Villena, Alicante, Spain
Centro Terapéutico para Alzheimer y otras demencias "Antonia Blanco Sánchez"
Mérida, Badajoz, Spain
AFAMA Pollença
Pollença, Balearic Islands, Spain
Centro Alois II
Cornellà de Llobregat, Barcelona, Spain
Asociación de familiares de personas con Alzheimer y otras demencias del Maresme
Mataró, Barcelona, Spain
Asociación de Familiares de Enfermos de Alzheimer de Iniesta (ADADI)
Iniesta, Cuenca, Spain
AFEAVA
Hervás, Cáceres, Spain
AFA Faro de Chipiona
Chipiona, Cádiz, Spain
Afa Puerto
El Puerto de Santa María, Cádiz, Spain
Asoc familiares de enfermos de Alzheimer y otras demencias afines de Fernán Núñez
Fernán Núñez, Córdoba, Spain
AFAMO
Montilla, Córdoba, Spain
AFASUR Genil
Puente-Genil, Córdoba, Spain
Asociación de familiares de enfermos de Alzheimer de Motril - Contigo
Motril, Granada, Spain
Asociación Alzheimer Bierzo
Ponferrada, León, Spain
Afa Santa Marina Del Rey
Santa Marina del Rey, León, Spain
Associació de Familiars i Malalts d'Alzheimer de Tàrrega i comarca
Tàrrega, Lleida, Spain
AFA Pozuelo
Pozuelo de Alarcón, Madrid, Spain
Asociación Alzheimer y otras Demencias Lorca
Lorca, Murcia, Spain
Centro de día Alzheimer Estepona
Estepona, Málaga, Spain
Centro de Día Nieves Barranco
Marbella, Málaga, Spain
AFADAX
Vélez-Málaga, Málaga, Spain
Asociación de Alzheimer "Virgen del Castillo"
Lebrija, Sevilla, Spain
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
ASFAL (Asociación de Familiares y Amigos de personas con Alzheimer de Algemesí)
Algemesí, Valencia, Spain
AFA Alginet
Alginet, Valencia, Spain
Centro de estimulación y Rehabilitación "La LLimera" de AFABALS
Benifaió, Valencia, Spain
AFA Benavente y Comarca
Benavente, Zamora, Spain
AFA Alicante
Alicante, , Spain
Alzheimer Ávila
Ávila, , Spain
Centre de Día AFA Barcelona
Barcelona, , Spain
AFA Alzhe de Cadiz
Cadiz, , Spain
Club de la memoria - Alzhei Cáceres
Cáceres, , Spain
Asociación San Rafael de Alzheimer y Otras Demencias
Córdoba, , Spain
AFA Huelva
Huelva, , Spain
Alzheimer León
León, , Spain
Asociación de Familiares y Enfermos de Alzheimer y otras demencias de La Rioja (AFA Rioja)
Logroño, , Spain
AFALU
Lugo, , Spain
AFA Málaga
Málaga, , Spain
Centro de Referencia estatal de atención a personas con enfermedad de Alzheimer y otras demencias - Imserso
Salamanca, , Spain
AGADEA
Santiago de Compostela, , Spain
AFAV (Asociación Familiares Enfermos de Alzheimer Valencia)
Valencia, , Spain
AFARABA
Vitoria-Gasteiz, Álava, Spain
Countries
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References
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Other Identifiers
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05/23
Identifier Type: -
Identifier Source: org_study_id
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