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

Effectiveness and Cost-Effectiveness of of Cognitive Stimulation Therapy - Spain (CST-ES) in People Living With Dementia: A Randomized Controlled Multicenter Clinical Trial

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Neurocognitive Disorders; Dementia; Mild Cognitive Impairment
• Intervention / Treatment: Behavioral: Cognitive Stimulation Therapy (CST)

Detailed Description

Spain is one of the countries with the most aged population, due to the increase in life expectancy and the decrease in the birth rate. As a result, the number of people affected by age-related pathologies, such as dementia, has increased. Dementia affects more than 700,000 people in Spain and it is expected that this number will be nearly two million people by 2050. For this reason, the Comprehensive Plan for Alzheimer's Disease and Other Dementias 2019-2023 states that addressing dementia is a public health priority and a major social and health problem.

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.

• Study Type: Interventional
• Enrollment (Actual): 683
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Alicante, Spain
    • AFA Alicante
  • Barcelona, Spain
    • Centre de Día AFA Barcelona
  • Cáceres, Spain
    • Club de la memoria - Alzhei Cáceres
  • Cádiz, Spain
    • AFA Alzhe de Cadiz
  • Córdoba, Spain
    • Asociación San Rafael de Alzheimer y Otras Demencias
  • Huelva, Spain
    • AFA Huelva
  • León, Spain
    • Alzheimer León
  • Logroño, Spain
    • Asociación de Familiares y Enfermos de Alzheimer y otras demencias de La Rioja (AFA Rioja)
  • Lugo, Spain
    • AFALU
  • Málaga, Spain
    • AFA Málaga
  • Salamanca, Spain, 37008
    • Centro de Referencia estatal de atención a personas con enfermedad de Alzheimer y otras demencias - Imserso
  • Santiago de Compostela, Spain
    • AGADEA
  • Valencia, Spain
    • AFAV (Asociación Familiares Enfermos de Alzheimer Valencia)
  • Ávila, Spain
    • Alzheimer Ávila
  • Alicante
    • Alcoy, Alicante, Spain
      • Centro de día de la Asociación de Familiares y Amigos de Enfermos de Alzheimer de Alcoy y Comarca
    • Castalla, Alicante, Spain
      • AFA Castalla y Onil
    • Elda, Alicante, Spain
      • AFA Elda, Petrer y Comarca del Medio Vinalopo
    • Teulada, Alicante, Spain
      • AFA Teulada - Moraira (Marina Alta)
    • Villena, Alicante, Spain
      • Asociación Familiares de Personas con Alzheimer de Villena y Comarca
  • Badajoz
    • Mérida, Badajoz, Spain
      • Centro Terapéutico para Alzheimer y otras demencias "Antonia Blanco Sánchez"
  • Barcelona
    • Cornellà De Llobregat, Barcelona, Spain
      • Centro Alois II
    • Mataró, Barcelona, Spain
      • Asociación de familiares de personas con Alzheimer y otras demencias del Maresme
  • Cuenca
    • Iniesta, Cuenca, Spain
      • Asociación de Familiares de Enfermos de Alzheimer de Iniesta (ADADI)
  • Cáceres
    • Hervás, Cáceres, Spain
      • AFEAVA
  • Cádiz
    • Chipiona, Cádiz, Spain
      • AFA Faro de Chipiona
    • El Puerto De Santa María, Cádiz, Spain
      • Afa Puerto
  • Córdoba
    • Fernán Núñez, Córdoba, Spain
      • Asoc familiares de enfermos de Alzheimer y otras demencias afines de Fernán Núñez
    • Montilla, Córdoba, Spain
      • AFAMO
    • Puente Genil, Córdoba, Spain
      • AFASUR Genil
  • Granada
    • Motril, Granada, Spain
      • Asociación de familiares de enfermos de Alzheimer de Motril - Contigo
  • Islas Baleares
    • Pollença, Islas Baleares, Spain
      • AFAMA Pollença
  • León
    • Ponferrada, León, Spain
      • Asociación Alzheimer Bierzo
    • Santa Marina del Rey, León, Spain
      • Afa Santa Marina Del Rey
  • Lleida
    • Tàrrega, Lleida, Spain
      • Associació de Familiars i Malalts d'Alzheimer de Tàrrega i comarca
  • Madrid
    • Pozuelo De Alarcón, Madrid, Spain
      • AFA Pozuelo
  • Murcia
    • Lorca, Murcia, Spain
      • Asociación Alzheimer y otras Demencias Lorca
  • Málaga
    • Estepona, Málaga, Spain
      • Centro de día Alzheimer Estepona
    • Marbella, Málaga, Spain
      • Centro de Día Nieves Barranco
    • Vélez-Málaga, Málaga, Spain
      • AFADAX
  • Sevilla
    • Lebrija, Sevilla, Spain
      • Asociación de Alzheimer "Virgen del Castillo"
  • Toledo
    • Talavera De La Reina, Toledo, Spain
      • AFATA Asociación de familiares y amigos de personas con deterioro cognitivo, enfermedad de Alzheimer y otras demencias de Talavera de la Reina
  • Valencia
    • Algemesí, Valencia, Spain
      • ASFAL (Asociación de Familiares y Amigos de personas con Alzheimer de Algemesí)
    • Alginet, Valencia, Spain
      • AFA Alginet
    • Benifayó, Valencia, Spain
      • Centro de estimulación y Rehabilitación "La LLimera" de AFABALS
  • Zamora
    • Benavente, Zamora, Spain
      • AFA Benavente y Comarca
  • Álava
    • Gasteiz / Vitoria, Álava, Spain
      • AFARABA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Participants in the control group will maintain their standard care, participating in those activities previously assigned in their individual care plan.
Experimental: 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.	Behavioral: 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 Names: Maintenance CST (mCST); Cognitive Stimulation Therapy España (CST-ES); Cognitive Stimulation Therapy España de mantenimiento (mCST-ES)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cognitive functioning assessed through Mini-Mental State Examination (MMSE)	Cognitive functioning assessed by the Mini-Mental State Examination (MMSE), a gold standard screening tool for assessing global cognitive function. Scores range from 0 to 30, with higher scores indicating better cognitive functioning.	Baseline (T0)
Change in Cognitive functioning assessed through Mini-Mental State Examination (MMSE)	Cognitive functioning assessed by the Mini-Mental State Examination (MMSE), a gold standard screening tool for assessing global cognitive function. Scores range from 0 to 30, with higher scores indicating better cognitive functioning.	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)	Cognitive functioning assessed by the Mini-Mental State Examination (MMSE), a gold standard screening tool for assessing global cognitive function. Scores range from 0 to 30, with higher scores indicating better cognitive functioning.	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)	EuroQol-5D 5-level version (EQ-5D-5L). The EQ-5D-5L is a generic instrument for the assessment of health-related quality of life that can be used in both relatively healthy individuals and in groups of patients with different disease conditions. The individual evaluates his or her own state of health first as severity levels by dimensions (mobility, self-care, daily activities, pain/ discomfort and anxiety/depression), and then using a more general evaluation visual analog scale (VAS). A third element is the social values index that is obtained for each health status generated by the instrument. The index ranges from 1 (best health status) to 0 (death), though there are negative values for the index, corresponding to those health statuses that are assessed as being worse than death. In this way, an index is obtained that can be used directly or combined with life years to calculate quality-adjusted life years (QALYs).	Baseline (T0)
Change in Quality of life evaluated through EuroQol-5D 5-level version (EQ-5D-5L)	EuroQol-5D 5-level version (EQ-5D-5L). The EQ-5D-5L is a generic instrument for the assessment of health-related quality of life that can be used in both relatively healthy individuals and in groups of patients with different disease conditions. The individual evaluates his or her own state of health first as severity levels by dimensions (mobility, self-care, daily activities, pain/ discomfort and anxiety/depression), and then using a more general evaluation visual analog scale (VAS). A third element is the social values index that is obtained for each health status generated by the instrument. The index ranges from 1 (best health status) to 0 (death), though there are negative values for the index, corresponding to those health statuses that are assessed as being worse than death. In this way, an index is obtained that can be used directly or combined with life years to calculate quality-adjusted life years (QALYs).	7 weeks after the start of the CST-ES program (First follow-up T1)
Change in Quality of life evaluated through EuroQol-5D 5-level version (EQ-5D-5L)	EuroQol-5D 5-level version (EQ-5D-5L). The EQ-5D-5L is a generic instrument for the assessment of health-related quality of life that can be used in both relatively healthy individuals and in groups of patients with different disease conditions. The individual evaluates his or her own state of health first as severity levels by dimensions (mobility, self-care, daily activities, pain/ discomfort and anxiety/depression), and then using a more general evaluation visual analog scale (VAS). A third element is the social values index that is obtained for each health status generated by the instrument. The index ranges from 1 (best health status) to 0 (death), though there are negative values for the index, corresponding to those health statuses that are assessed as being worse than death. In this way, an index is obtained that can be used directly or combined with life years to calculate quality-adjusted life years (QALYs).	24 weeks after the start of CST-ES maintenance program (second follow-up and endpoint assessment, T2)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Resource utilization evaluated through Resource Utilization in Dementia (RUD)	The Resource Utilization in Dementia (RUD) instrument is a standardized tool and the most widely used instrument for resource use data collection in dementia. The RUD assesses resource use of both patients and caregivers and consists of a baseline assessment and follow-up assessments. The RUD is administrated as an interview with the primary caregiver or other person with knowledge about the patient´s living situation.	Baseline (T0)
Change in resource utilization evaluated through Resource Utilization in Dementia (RUD)	The Resource Utilization in Dementia (RUD) instrument is a standardized tool and the most widely used instrument for resource use data collection in dementia. The RUD assesses resource use of both patients and caregivers and consists of a baseline assessment and follow-up assessments. The RUD is administrated as an interview with the primary caregiver or other person with knowledge about the patient´s living situation.	24 weeks after the start of CST-ES maintenance program (second follow-up and endpoint assessment, T2)
Sociodemographic information gathered through the sociodemographic questionnaire	The sociodemographic questionnaire was designed specifically for this study. It gathers information about the participants' gender, age, marital status, educational level, sensory deficit, diagnosis, and pharmacological treatment. It will be administered to all participants.	Baseline (T0)
Adherence to the intervention and dropouts evaluated through a session form	Adherence to the intervention and dropouts will be assessed using a session form, designed specifically for this study, completed by the technician after each session, tracking the attendance and mood/behaviour of the participants throughout the intervention sessions.	After each of the intervention sessions

Collaborators and Investigators

• Sponsor: Instituto de Mayores y Servicios Sociales (IMSERSO)
• Collaborators: University of Castilla-La Mancha; Confederación Española de Alzheimer (CEAFA)
• Investigators: Study Director: Enrique Pérez-Sáez, Phd, CRE de atención a personas con enfermedad de Alzheimer y otras demencias - Imserso; Principal Investigator: Luz María Peña Longobardo, Phd, University of Castilla-La Mancha

Publications and helpful links

General Publications

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Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2023
• Primary Completion (Estimated): July 31, 2024
• Study Completion (Estimated): July 31, 2024

Study Registration Dates

• First Submitted: April 11, 2024
• First Submitted That Met QC Criteria: April 16, 2024
• First Posted (Actual): April 17, 2024

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: quality of life; neuropsychiatric symptoms; cognition; Mild Cognitive Impairment; Dementia; cost-effectiveness; Cognitive stimulation; Neurocognitive Disorders; older adult; cognition oriented treatment
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Cognition Disorders; Dementia; Cognitive Dysfunction; Neurocognitive Disorders
• Other Study ID Numbers: 05/23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No