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

NCT06372002 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 683

Last updated 2024-04-17

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • University of Castilla-La Mancha

    collaborator OTHER

  • Confederación Española de Alzheimer (CEAFA)

    collaborator UNKNOWN

  • Instituto de Mayores y Servicios Sociales (IMSERSO)

    lead OTHER_GOV

Principal Investigators

  • Enrique Pérez-Sáez, Phd · CRE de atención a personas con enfermedad de Alzheimer y otras demencias - Imserso

  • Luz María Peña Longobardo, Phd · University of Castilla-La Mancha

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-16
Primary Completion
2024-07-31
Completion
2024-07-31

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06372002 on ClinicalTrials.gov