Psychotic DisordersNCT04783285
Effect of Individual Cognitive Stimulation at Home in Adults With Psychotic Disorders
A study testing Individual cognitive stimulation therapy (iCST) in people with Psychotic Disorders and Schizophrenia, run by CEDIARA - Assoc. Solidariedade Social de Ribeira de Fráguas at 1 site in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Psychotic Disorders, Schizophrenia, Schizoaffective Disorder
- What is being tested?
- Individual cognitive stimulation therapy (iCST)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 sitePortugal
- Study dates
- 29 Mar 2021to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Cediara - Social Solidarity Association of Ribeira de Fráguas
Albergaria-a-Velha, Aveiro District, 3850-705
About this study
Official title: Effect of Individual Cognitive Stimulation at Home in Adults With Psychotic Disorders: Randomised Controlled Trial
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).
Read the 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
- Being tested
- Individual cognitive stimulation therapy (iCST)
- Keywords
- cognition, mood, executive functions, quality of life, non-pharmacological therapy, randomised controlled trial, schizophrenia, psychotic disorders, cognitive stimulation
- Medical subject headings
- Psychotic Disorders, Schizophrenia, Schizophrenia, Paranoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individual cognitive stimulation therapy (iCST)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | 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. Receives: Behavioral: Individual cognitive stimulation therapy (iCST) |
| Control Group | No intervention | Participants assigned to the control group will maintain their usual treatment: social interaction activities, stimulation of personal skills, and any prescribed psychotic-specific medication. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive functioning evaluated through Montreal Cognitive Assessment [MoCA]
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.
Measured: baseline
Change in cognitive functioning evaluated through MoCA
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.
Measured: 8 weeks after the beginning of the intervention
Change in cognitive functioning evaluated through MoCA
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.
Measured: 16 weeks after the beginning of the intervention
Change in cognitive functioning evaluated through MoCA
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.
Measured: 8 weeks after end of intervention
Executive functions evaluated through Frontal Assessment Battery (FAB)
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.
Measured: baseline
Change in executive functions evaluated through FAB
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.
Measured: 8 weeks after the beginning of the intervention
Change in executive functions evaluated through FAB
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.
Measured: 16 weeks after the beginning of the intervention
Change in executive functions evaluated through FAB
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.
Measured: 8 weeks after end of intervention
Secondary outcomes (16)
Self-maintaining and instrumental activities of daily living evaluated through Lawton Instrumental Activities of Daily Living (IADL) Scale
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.
Measured: baseline
Change in self-maintaining and instrumental activities of daily living evaluated through Lawton IADL Scale
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.
Measured: 8 weeks after the beginning of the intervention
Change in self-maintaining and instrumental activities of daily living evaluated through Lawton IADL Scale
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.
Measured: 16 weeks after the beginning of the intervention
Change in self-maintaining and instrumental activities of daily living evaluated through Lawton IADL Scale
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.
Measured: 8 weeks after end of intervention
Depressive symptomatology assessed through the Center for Epidemiologic Studies Depression Scale (CES-D)
This instrument evaluated depressive symptoms using 20 answers. Scores range between 0 and 60 points. Higher scores indicate more severe depressive symptoms.
Measured: baseline
Change in depressive symptomatology assessed through the CES-D
This instrument evaluated depressive symptoms using 20 answers. Scores range between 0 and 60 points. Higher scores indicate more severe depressive symptoms.
Measured: 8 weeks after the beginning of the intervention
Change in depressive symptomatology assessed through the CES-D
This instrument evaluated depressive symptoms using 20 answers. Scores range between 0 and 60 points. Higher scores indicate more severe depressive symptoms.
Measured: 16 weeks after the beginning of the intervention
Change in depressive symptomatology assessed through the CES-D
This instrument evaluated depressive symptoms using 20 answers. Scores range between 0 and 60 points. Higher scores indicate more severe depressive symptoms.
Measured: 8 weeks after end of intervention
Quality of life (QoL) evaluated through World Health Organization Quality of Life-Bref (WHOQOL-BREF)
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.
Measured: baseline
Change in QoL evaluated through WHOQOL-BREF
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.
Measured: 8 weeks after the beginning of the intervention
Change in QoL evaluated through WHOQOL-BREF
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.
Measured: 16 weeks after the beginning of the intervention
Change in QoL evaluated through WHOQOL-BREF
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.
Measured: 8 weeks after end of intervention
Quality of life (QoL) evaluated through MOS Short Form Health Survey 36 Item v2 (SF-36v2)
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.
Measured: baseline
Change in QoL evaluated through SF-36v2
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.
Measured: 8 weeks after the beginning of the intervention
Change in QoL evaluated through SF-36v2
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.
Measured: 16 weeks after the beginning of the intervention
Change in QoL evaluated through SF-36v2
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.
Measured: 8 weeks after end of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2021
- Study start29 Mar 2021
- Primary completion22 Oct 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychotic DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- CEDIARA - Assoc. Solidariedade Social de Ribeira de Fráguas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Susana I Justo Henriques, Ph.D., Principal investigator, Health Sciences Research Unit: Nursing (UICISA: E), Nursing School of CoimbraAna E Marques Castro, M.Sc., Principal investigator, Cediara - Associação de Solidariedade Social de Ribeira de FráguasEnrique Pérez Sáez, Ph.D., Principal investigator, National Reference Centre for Alzheimer's and Dementia Care, Imserso, SpainJanessa O Carvalho, Ph.D., Principal investigator, Bridgewater State University, Bridgewater, USAAna P Sargaço Mendes, MD, Principal investigator, Centro Hospitalar do Baixo Vouga, Aveiro, Portugal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04783285
- Sponsor's protocol ID
- 20210218
- Status last verified
- Feb 2021
- First submitted
- 1 Mar 2021
- Last updated
- 10 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Individual Cognitive Stimulation at Home in Adults With Psychotic Disorders: Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04783285
- Acronym / sponsor ID
- 20210218
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- CEDIARA - Assoc. Solidariedade Social de Ribeira de FráguasUniversity, hospital or other
- Study start
- 29 Mar 2021 (actual)
- Primary completion
- 22 Oct 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 5 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: 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. |
| Control Group | No intervention | –Participants assigned to the control group will maintain their usual treatment: social interaction activities, stimulation of personal skills, and any prescribed psychotic-specific medication. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Intervention Group |
Primary outcome
Cognitive functioning evaluated through Montreal Cognitive Assessment [MoCA]
Time frame: 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 cognitive functioning evaluated through MoCA
Time frame: 8 weeks after the beginning of the 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.
Change in cognitive functioning evaluated through MoCA
Time frame: 16 weeks after the beginning of the 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.
Change in cognitive functioning evaluated through MoCA
Time frame: 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.
Executive functions evaluated through Frontal Assessment Battery (FAB)
Time frame: 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 executive functions evaluated through FAB
Time frame: 8 weeks after the beginning of the 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.
Change in executive functions evaluated through FAB
Time frame: 16 weeks after the beginning of the 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.
Change in executive functions evaluated through FAB
Time frame: 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.
16 secondary outcomes
Self-maintaining and instrumental activities of daily living evaluated through Lawton Instrumental Activities of Daily Living (IADL) Scale
Time frame: baseline
Change in self-maintaining and instrumental activities of daily living evaluated through Lawton IADL Scale
Time frame: 8 weeks after the beginning of the intervention
Change in self-maintaining and instrumental activities of daily living evaluated through Lawton IADL Scale
Time frame: 16 weeks after the beginning of the intervention
Change in self-maintaining and instrumental activities of daily living evaluated through Lawton IADL Scale
Time frame: 8 weeks after end of intervention
Depressive symptomatology assessed through the Center for Epidemiologic Studies Depression Scale (CES-D)
Time frame: baseline
Change in depressive symptomatology assessed through the CES-D
Time frame: 8 weeks after the beginning of the intervention
Change in depressive symptomatology assessed through the CES-D
Time frame: 16 weeks after the beginning of the intervention
Change in depressive symptomatology assessed through the CES-D
Time frame: 8 weeks after end of intervention
Quality of life (QoL) evaluated through World Health Organization Quality of Life-Bref (WHOQOL-BREF)
Time frame: baseline
Change in QoL evaluated through WHOQOL-BREF
Time frame: 8 weeks after the beginning of the intervention
Change in QoL evaluated through WHOQOL-BREF
Time frame: 16 weeks after the beginning of the intervention
Change in QoL evaluated through WHOQOL-BREF
Time frame: 8 weeks after end of intervention
Quality of life (QoL) evaluated through MOS Short Form Health Survey 36 Item v2 (SF-36v2)
Time frame: baseline
Change in QoL evaluated through SF-36v2
Time frame: 8 weeks after the beginning of the intervention
Change in QoL evaluated through SF-36v2
Time frame: 16 weeks after the beginning of the intervention
Change in QoL evaluated through SF-36v2
Time frame: 8 weeks after end of intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susana I Justo Henriques, Ph.D. principal investigator
Health Sciences Research Unit: Nursing (UICISA: E), Nursing School of Coimbra
Ana E Marques Castro, M.Sc. principal investigator
Cediara - Associação de Solidariedade Social de Ribeira de Fráguas
Enrique Pérez Sáez, Ph.D. principal investigator
National Reference Centre for Alzheimer's and Dementia Care, Imserso, Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individual cognitive stimulation therapy (iCST) in people with Psychotic Disorders and Schizophrenia, run by CEDIARA - Assoc. Solidariedade Social de Ribeira de Fráguas at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive functioning evaluated through Montreal Cognitive Assessment [MoCA] (time frame: baseline). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2022.