Ignite Creation Date:
2024-05-06 @ 3:51 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04783285
Status:
COMPLETED
Last Update Posted:
2022-03-10
First Post:
2021-03-01
Brief Title:
Effect of Individual Cognitive Stimulation at Home in Adults With Psychotic Disorders
Sponsor:
CEDIARA - Assoc Solidariedade Social de Ribeira de Fráguas
Organization:
CEDIARA - Assoc Solidariedade Social de Ribeira de Fráguas
Study Overview
Official Title:
Effect of Individual Cognitive Stimulation at Home in Adults With Psychotic Disorders Randomised Controlled Trial
Status:
COMPLETED
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 eg 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
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 eg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None