Effect of Individual Cognitive Stimulation at Home in Adults With Psychotic Disorders
- Conditions
- SchizophreniaDelusional DisorderSubstance-Induced Psychotic DisorderPsychotic DisordersSchizoaffective Disorder
- Interventions
- Behavioral: Individual cognitive stimulation therapy (iCST)
- Registration Number
- NCT04783285
- Lead Sponsor
- CEDIARA - Assoc. Solidariedade Social de Ribeira de Fráguas
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 38
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Group Individual cognitive stimulation therapy (iCST) 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.
- Primary Outcome Measures
Name Time Method Executive functions evaluated through Frontal Assessment Battery (FAB) baseline The FAB is used to assess executive function in several subtests: conceptualization, mental flexibility, motor programming, sensitivity to interference, inhibitory control, and environmental autonomy. Scores range from 0 to 18, with higher scores indicating better executive functioning.
Change in cognitive functioning evaluated through MoCA 8 weeks after end of intervention Cognitive functioning is assessed using the MoCA which is a brief cognitive screening. Scores range from 0 to 30, with higher scores indicating better cognitive functioning.
Cognitive functioning evaluated through Montreal Cognitive Assessment [MoCA] baseline Cognitive functioning is assessed using the MoCA which is a brief cognitive screening. Scores range from 0 to 30, with higher scores indicating better cognitive functioning.
Change in executive functions evaluated through FAB 8 weeks after end of intervention The FAB is used to assess executive function in several subtests: conceptualization, mental flexibility, motor programming, sensitivity to interference, inhibitory control, and environmental autonomy. Scores range from 0 to 18, with higher scores indicating better executive functioning.
- Secondary Outcome Measures
Name Time Method Change in QoL evaluated through SF-36v2 8 weeks after end of intervention The SF-36v2 is used to assess QoL. Consisting of 36 items, it assesses eight dimensions of health (dimensions of health (physical, performance limitations due to physical or emotional problems, intensity and discomfort due to pain, general health, vitality, social function and mental health). The global score range between 0 to 100. Higher scores indicate better the health-related QoL.
Quality of life (QoL) evaluated through MOS Short Form Health Survey 36 Item v2 (SF-36v2) baseline The SF-36v2 is used to assess QoL. Consisting of 36 items, it assesses eight dimensions of health (dimensions of health (physical, performance limitations due to physical or emotional problems, intensity and discomfort due to pain, general health, vitality, social function and mental health). The global score range between 0 to 100. Higher scores indicate better the health-related QoL.
Depressive symptomatology assessed through the Center for Epidemiologic Studies Depression Scale (CES-D) baseline This instrument evaluated depressive symptoms using 20 answers. Scores range between 0 and 60 points. Higher scores indicate more severe depressive symptoms.
Change in depressive symptomatology assessed through the CES-D 8 weeks after end of intervention This instrument evaluated depressive symptoms using 20 answers. Scores range between 0 and 60 points. Higher scores indicate more severe depressive symptoms.
Quality of life (QoL) evaluated through World Health Organization Quality of Life-Bref (WHOQOL-BREF) baseline The WHOQOL-BREF is used to assess QoL. Consisting of 26 items, it assesses several domains: physical health, mental health, social relationships and environment. The first 2 items are intended to assess the individual's perception of his/her general QoL and general health. The global score range between 0 to 100. Higher scores indicate better QoL perceived by the subject.
Self-maintaining and instrumental activities of daily living evaluated through Lawton Instrumental Activities of Daily Living (IADL) Scale baseline Lawton IADL Scale assesses level of independence of the elderly in relation to instrumental activities of daily living. A score is assigned according to the subject's ability to perform a given task. The score ranges between 8 and 30 points. The highest score corresponds to a higher degree of dependence.
Change in self-maintaining and instrumental activities of daily living evaluated through Lawton IADL Scale 8 weeks after end of intervention Lawton IADL Scale assesses level of independence of the elderly in relation to instrumental activities of daily living. A score is assigned according to the subject's ability to perform a given task. The score ranges between 8 and 30 points. The highest score corresponds to a higher degree of dependence.
Change in QoL evaluated through WHOQOL-BREF 8 weeks after end of intervention The WHOQOL-BREF is used to assess QoL. Consisting of 26 items, it assesses several domains: physical health, mental health, social relationships and environment. The first 2 items are intended to assess the individual's perception of his/her general QoL and general health. The global score range between 0 to 100. Higher scores indicate better QoL perceived by the subject.
Trial Locations
- Locations (1)
Cediara - Social Solidarity Association of Ribeira de Fráguas
🇵🇹Albergaria-a-Velha, Aveiro, Portugal