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

NCT ID: NCT04783285

Last Updated: 2022-03-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-29
• Study Completion Date: 2021-12-31

Brief 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).

Detailed Description

Epidemiological studies indicate that Portugal has one of the highest prevalence rates of mental disorders in Europe. In 2016, one in five Portuguese suffered from a psychiatric illness and the network of Integrated Continuous Care in mental health is small, which is a major constraint to rehabilitation and support responses for people with mental health problems.

It is important to include psychologists and neuropsychologists in multidisciplinary teams, in actions related to mental health promotion and mental illness prevention programs, so that they can provide more comprehensive interventions for other effects of chronic mental health conditions, such as cognitive decline.

There is evidence linking psychotic disorders to impairments in functioning in most cognitive domains, including memory, executive functions, and attention, and that cognitive ageing in some areas may be accelerated in individuals with psychotic disorders. Thus, it is important to focus interventions on cognitive functioning in patients with psychosis, even after acute psychotic symptoms have improved. Executive functions appear to be of particular importance in the context of mental health problems, as they appear to be particularly integral for psychosocial functioning and the completion of instrumental activities of daily living. There is evidence that CS interventions in individual format are associated with greater effectiveness.

Many studies have supported the effectiveness and accessibility of home-based interventions in people with chronic mental illness. Yet, there are few published studies on continuous intervention in people with chronic mental illness and even more limited knowledge of how cognitive stimulation can help chronic mental health patients, including those with psychosis, to function.

One Portuguese study about the effect of an individual CS program in a home setting on cognitive and mood functioning in adults with psychotic disorders was tested, showed encouraging results and presented in detail an intervention protocol. However, it also presents some important limitations (e.g., convenience sample, lack of follow-up evaluation).

This study aims to overcome those limitations, through a randomised controlled trial, and, in addition to testing the effect of the CS program on global cognition, it also aims to assess its effect on emotional state, daily functioning, and quality of life.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Intervention Group

Participants who meet the inclusion criteria will be randomly assigned to the intervention group receiving CS or to a control group receiving treatment as usual. Participants in the intervention group will participate in two CS sessions per week for 16 weeks besides their treatment as usual. The sessions will be based on the existing protocol.

Group Type: EXPERIMENTAL

Individual cognitive stimulation therapy (iCST)

Intervention Type: BEHAVIORAL

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.

Control Group

Participants assigned to the control group will maintain their usual treatment: social interaction activities, stimulation of personal skills, and any prescribed psychotic-specific medication.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Adults under 65 years.
• Diagnosed with of schizophrenia spectrum and other psychotic disorders according to the criteria of DSM-5 (APA, 2013), determined by a professional clinician.
• Willing to participate in all intervention and assessment sessions.
• Provided informed consent.
• Native speakers of Portuguese.

Exclusion Criteria

• Presentation of a condition requiring immediate intervention (e.g., suicidal thoughts).
• Severe sensory and physical limitations that prevent participation in the sessions.
• Severe disconnection with the environment and very limited attentional level.
• Inability to communicate adequately.
• Psychoactive substance use.
• Currently participating in another study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CEDIARA - Assoc. Solidariedade Social de Ribeira de Fráguas

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Susana I Justo Henriques, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Health Sciences Research Unit: Nursing (UICISA: E), Nursing School of Coimbra

Ana E Marques Castro, M.Sc.

Role: PRINCIPAL_INVESTIGATOR

Cediara - Associação de Solidariedade Social de Ribeira de Fráguas

Enrique Pérez Sáez, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

National Reference Centre for Alzheimer's and Dementia Care, Imserso, Spain

Janessa O Carvalho, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Bridgewater State University, Bridgewater, USA

Ana P Sargaço Mendes, MD

Role: PRINCIPAL_INVESTIGATOR

Centro Hospitalar do Baixo Vouga, Aveiro, Portugal

Locations

Cediara - Social Solidarity Association of Ribeira de Fráguas

Albergaria-a-Velha, Aveiro District, Portugal

Countries

Portugal

Other Identifiers

20210218

Identifier Type: -

Identifier Source: org_study_id