Effect of Individual Cognitive Stimulation at Home in Adults With Psychotic Disorders

NCT04783285 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2022-03-10

No results posted yet for this study

Summary

The aim of this study is to test the effect of cognitive stimulation (CS), applied individually and at home, on the overall cognitive functioning, emotional state, functionality, and quality of life (QoL) in adults with psychotic disorders. To this end, a randomised controlled clinical trial will be conducted in which selected participants will be randomly assigned to an individual intervention group using CS or a control group. The CS program is adapted from other existing protocol, composed of 32 sessions. Each session will last 45 minutes and will be held twice weekly. There will be four evaluation points (baseline, intra-evaluation - after 8 weeks of intervention, post-evaluation - after 16 weeks of intervention, follow-up - after 8 weeks of the end of intervention).

Conditions

  • Psychotic Disorders
  • Schizophrenia
  • Schizoaffective Disorder
  • Delusional Disorder
  • Substance-Induced Psychotic Disorder

Interventions

BEHAVIORAL

Individual cognitive stimulation therapy (iCST)

The intervention group will receive 32 individual CS sessions per participant. Each session will last approximately 45 minutes and will have the following structure: session introduction (5 minutes); reality orientation (10 minutes); stimulation of cognitive domain (25 minutes); session closure (5 minutes). The sessions will be led by a previously trained therapist. The intervention program will include several activities based on the principles of CS and adjusted for participants with psychotic disorders.

Sponsors & Collaborators

  • CEDIARA - Assoc. Solidariedade Social de Ribeira de Fráguas

    lead OTHER

Principal Investigators

  • Susana I Justo Henriques, Ph.D. · Health Sciences Research Unit: Nursing (UICISA: E), Nursing School of Coimbra

  • Ana E Marques Castro, M.Sc. · Cediara - Associação de Solidariedade Social de Ribeira de Fráguas

  • Enrique Pérez Sáez, Ph.D. · National Reference Centre for Alzheimer's and Dementia Care, Imserso, Spain

  • Janessa O Carvalho, Ph.D. · Bridgewater State University, Bridgewater, USA

  • Ana P Sargaço Mendes, MD · Centro Hospitalar do Baixo Vouga, Aveiro, Portugal

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-29
Primary Completion
2021-10-22
Completion
2021-12-31

Countries

  • Portugal

Study Locations

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Entities

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 NCT04783285 on ClinicalTrials.gov