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

Primary Purpose

Psychotic Disorders, Schizophrenia, Schizoaffective Disorder

Status
Completed
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
Individual cognitive stimulation therapy (iCST)
Sponsored by
CEDIARA - Assoc. Solidariedade Social de Ribeira de Fráguas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psychotic Disorders focused on measuring cognition, mood, executive functions, quality of life, non-pharmacological therapy, randomised controlled trial, schizophrenia, psychotic disorders, cognitive stimulation

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Cediara - Social Solidarity Association of Ribeira de Fráguas

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Group

Control Group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
March 1, 2021
Last Updated
March 8, 2022
Sponsor
CEDIARA - Assoc. Solidariedade Social de Ribeira de Fráguas
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1. Study Identification

Unique Protocol Identification Number
NCT04783285
Brief Title
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

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
March 29, 2021 (Actual)
Primary Completion Date
October 22, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CEDIARA - Assoc. Solidariedade Social de Ribeira de Fráguas

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Participants assigned to the control group will maintain their usual treatment: social interaction activities, stimulation of personal skills, and any prescribed psychotic-specific medication.
Intervention Type
Behavioral
Intervention Name(s)
Individual cognitive stimulation therapy (iCST)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cognitive functioning evaluated through Montreal Cognitive Assessment [MoCA]
Description
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.
Time Frame
baseline
Title
Change in cognitive functioning evaluated through MoCA
Description
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.
Time Frame
8 weeks after the beginning of the intervention
Title
Change in cognitive functioning evaluated through MoCA
Description
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.
Time Frame
16 weeks after the beginning of the intervention
Title
Change in cognitive functioning evaluated through MoCA
Description
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.
Time Frame
8 weeks after end of intervention
Title
Executive functions evaluated through Frontal Assessment Battery (FAB)
Description
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.
Time Frame
baseline
Title
Change in executive functions evaluated through FAB
Description
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.
Time Frame
8 weeks after the beginning of the intervention
Title
Change in executive functions evaluated through FAB
Description
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.
Time Frame
16 weeks after the beginning of the intervention
Title
Change in executive functions evaluated through FAB
Description
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.
Time Frame
8 weeks after end of intervention
Secondary Outcome Measure Information:
Title
Self-maintaining and instrumental activities of daily living evaluated through Lawton Instrumental Activities of Daily Living (IADL) Scale
Description
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.
Time Frame
baseline
Title
Change in self-maintaining and instrumental activities of daily living evaluated through Lawton IADL Scale
Description
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.
Time Frame
8 weeks after the beginning of the intervention
Title
Change in self-maintaining and instrumental activities of daily living evaluated through Lawton IADL Scale
Description
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.
Time Frame
16 weeks after the beginning of the intervention
Title
Change in self-maintaining and instrumental activities of daily living evaluated through Lawton IADL Scale
Description
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.
Time Frame
8 weeks after end of intervention
Title
Depressive symptomatology assessed through the Center for Epidemiologic Studies Depression Scale (CES-D)
Description
This instrument evaluated depressive symptoms using 20 answers. Scores range between 0 and 60 points. Higher scores indicate more severe depressive symptoms.
Time Frame
baseline
Title
Change in depressive symptomatology assessed through the CES-D
Description
This instrument evaluated depressive symptoms using 20 answers. Scores range between 0 and 60 points. Higher scores indicate more severe depressive symptoms.
Time Frame
8 weeks after the beginning of the intervention
Title
Change in depressive symptomatology assessed through the CES-D
Description
This instrument evaluated depressive symptoms using 20 answers. Scores range between 0 and 60 points. Higher scores indicate more severe depressive symptoms.
Time Frame
16 weeks after the beginning of the intervention
Title
Change in depressive symptomatology assessed through the CES-D
Description
This instrument evaluated depressive symptoms using 20 answers. Scores range between 0 and 60 points. Higher scores indicate more severe depressive symptoms.
Time Frame
8 weeks after end of intervention
Title
Quality of life (QoL) evaluated through World Health Organization Quality of Life-Bref (WHOQOL-BREF)
Description
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.
Time Frame
baseline
Title
Change in QoL evaluated through WHOQOL-BREF
Description
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.
Time Frame
8 weeks after the beginning of the intervention
Title
Change in QoL evaluated through WHOQOL-BREF
Description
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.
Time Frame
16 weeks after the beginning of the intervention
Title
Change in QoL evaluated through WHOQOL-BREF
Description
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.
Time Frame
8 weeks after end of intervention
Title
Quality of life (QoL) evaluated through MOS Short Form Health Survey 36 Item v2 (SF-36v2)
Description
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.
Time Frame
baseline
Title
Change in QoL evaluated through SF-36v2
Description
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.
Time Frame
8 weeks after the beginning of the intervention
Title
Change in QoL evaluated through SF-36v2
Description
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.
Time Frame
16 weeks after the beginning of the intervention
Title
Change in QoL evaluated through SF-36v2
Description
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.
Time Frame
8 weeks after end of intervention
Other Pre-specified Outcome Measures:
Title
Sociodemographic information gathered through the sociodemographic questionnaire
Description
Participants' answers in the sociodemographic questionnaire designed specifically for this study. It gathers information about gender, age, marital status, educational level, clinical diagnosis and will be administered to all participants.
Time Frame
baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susana I Justo Henriques, Ph.D.
Organizational Affiliation
Health Sciences Research Unit: Nursing (UICISA: E), Nursing School of Coimbra
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ana E Marques Castro, M.Sc.
Organizational Affiliation
Cediara - Associação de Solidariedade Social de Ribeira de Fráguas
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Enrique Pérez Sáez, Ph.D.
Organizational Affiliation
National Reference Centre for Alzheimer's and Dementia Care, Imserso, Spain
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Janessa O Carvalho, Ph.D.
Organizational Affiliation
Bridgewater State University, Bridgewater, USA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ana P Sargaço Mendes, MD
Organizational Affiliation
Centro Hospitalar do Baixo Vouga, Aveiro, Portugal
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cediara - Social Solidarity Association of Ribeira de Fráguas
City
Albergaria-a-Velha
State/Province
Aveiro
ZIP/Postal Code
3850-705
Country
Portugal

12. IPD Sharing Statement

Plan to Share IPD
No

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

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