Clinical trial NCT04783285: Effect of Individual Cognitive Stimulation at Home in Adults With Psychotic Disorders
Official title: Effect of Individual Cognitive Stimulation at Home in Adults With Psychotic Disorders: Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychotic Disorders
Schizophrenia
Schizoaffective Disorder
Delusional Disorder
Substance-Induced Psychotic Disorder
Keywords: cognition
mood
executive functions
quality of life
non-pharmacological therapy
randomised controlled trial
schizophrenia
psychotic disorders
cognitive stimulation
Lead sponsor: CEDIARA - Assoc. Solidariedade Social de Ribeira de Fráguas
Sponsor class: OTHER
First posted: 2021-03-05
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Cognitive functioning evaluated through Montreal Cognitive Assessment [MoCA]
timeFrame: baseline
measure: Change in cognitive functioning evaluated through MoCA
timeFrame: 8 weeks after the beginning of the intervention
measure: Change in cognitive functioning evaluated through MoCA
timeFrame: 16 weeks after the beginning of the intervention
measure: Change in cognitive functioning evaluated through MoCA
timeFrame: 8 weeks after end of intervention
measure: Executive functions evaluated through Frontal Assessment Battery (FAB)
timeFrame: baseline
measure: Change in executive functions evaluated through FAB
timeFrame: 8 weeks after the beginning of the intervention
measure: Change in executive functions evaluated through FAB
timeFrame: 16 weeks after the beginning of the intervention
measure: Change in executive functions evaluated through FAB
timeFrame: 8 weeks after end of intervention
Secondary outcomes:
measure: Self-maintaining and instrumental activities of daily living evaluated through Lawton Instrumental Activities of Daily Living (IADL) Scale
timeFrame: baseline
measure: Change in self-maintaining and instrumental activities of daily living evaluated through Lawton IADL Scale
timeFrame: 8 weeks after the beginning of the intervention
measure: Change in self-maintaining and instrumental activities of daily living evaluated through Lawton IADL Scale
timeFrame: 16 weeks after the beginning of the intervention
measure: Change in self-maintaining and instrumental activities of daily living evaluated through Lawton IADL Scale
timeFrame: 8 weeks after end of intervention
measure: Depressive symptomatology assessed through the Center for Epidemiologic Studies Depression Scale (CES-D)
timeFrame: baseline
measure: Change in depressive symptomatology assessed through the CES-D
timeFrame: 8 weeks after the beginning of the intervention
measure: Change in depressive symptomatology assessed through the CES-D
timeFrame: 16 weeks after the beginning of the intervention
measure: Change in depressive symptomatology assessed through the CES-D
timeFrame: 8 weeks after end of intervention
measure: Quality of life (QoL) evaluated through World Health Organization Quality of Life-Bref (WHOQOL-BREF)
timeFrame: baseline
measure: Change in QoL evaluated through WHOQOL-BREF
timeFrame: 8 weeks after the beginning of the intervention
measure: Change in QoL evaluated through WHOQOL-BREF
timeFrame: 16 weeks after the beginning of the intervention
measure: Change in QoL evaluated through WHOQOL-BREF
timeFrame: 8 weeks after end of intervention
measure: Quality of life (QoL) evaluated through MOS Short Form Health Survey 36 Item v2 (SF-36v2)
timeFrame: baseline
measure: Change in QoL evaluated through SF-36v2
timeFrame: 8 weeks after the beginning of the intervention
measure: Change in QoL evaluated through SF-36v2
timeFrame: 16 weeks after the beginning of the intervention
measure: Change in QoL evaluated through SF-36v2
timeFrame: 8 weeks after end of intervention
Other outcomes:
measure: Sociodemographic information gathered through the sociodemographic questionnaire
timeFrame: baseline
Locations:
city: Albergaria-a-Velha
country: Portugal
facility: Cediara - Social Solidarity Association of Ribeira de Fráguas
state: Aveiro
Study officials:
affiliation: Health Sciences Research Unit: Nursing (UICISA: E), Nursing School of Coimbra
name: Susana I Justo Henriques, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Cediara - Associação de Solidariedade Social de Ribeira de Fráguas
name: Ana E Marques Castro, M.Sc.
role: PRINCIPAL_INVESTIGATOR
affiliation: National Reference Centre for Alzheimer's and Dementia Care, Imserso, Spain
name: Enrique Pérez Sáez, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Bridgewater State University, Bridgewater, USA
name: Janessa O Carvalho, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Centro Hospitalar do Baixo Vouga, Aveiro, Portugal
name: Ana P Sargaço Mendes, MD
role: PRINCIPAL_INVESTIGATOR
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