Online TP (Training Program) on SC (Social Cognition) for Schizophrenia

Study Overview
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Brief Summary
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Randomized controlled trial. Sixty-five participants (83% with schizophrenia or bipolar disorder) were recruited from community mental health teams. Fifty-seven met criteria and agreed to participate in the study. The conditions of cognitive rehabilitation were assigned randomly with support employment CR + IPS (n = 28) and IPS alone (n = 29). Cogpack program was used. Two groups were followed at 8 and 12 months after the baseline.

Detailed Description
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This work was developed in the island of Tenerife (Spain) within a public service specialised in labour integration of people with disabilities in which an IPS team was set up in 2005. The study was carried out in collaboration with the units of community mental health of the island. These units carry out the control of people with serious mental illnesses including pharmacological treatment and psychosocial programming. All research procedures were approved by the Medicine Committee of Canary Health Services. The follow-up period for the data collection was set between 2013 and 2014. Employment specialists belong to a public institution specialized in work disability.Sixty-five participants but only 57 signed written informed consent and completed the baseline. Two groups were assigned randomly:one with support employment and cognitive rehabilitation the second group with IPS alone

Official Title
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Online Training Program on Social Cognition for Patients With Schizophrenia

Conditions
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Social Cognition

Intervention / Treatment
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* Other: Cognitive Rehabilitation and Individual Placement and Support


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants had to: comply with the state definitions of severe mental illness (SMI), which includes an ICD-10 (World Health Organization, 1992) diagnosis of F20- 29 (schizophrenia, schizotypal, delusional and other non-mood psychotic disorders) and F31-F32.3 (major mood affective disorders) have previous difficulties to maintain a job currently want a competitive job and accept the job search starts Exclusion Criteria: People with no Severe mental illness and not want to participate

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Cognitive rehabilitation with a cognitive training program
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Experimental Group (e-Motional Training and Individual Placement and Support) | Other: Cognitive Rehabilitation and Individual Placement and Support<br>* Cognitive Rehabilitation and Individual Placement and Support<br>* Other names: CR and IPS;|
| No Intervention: Control<br>Control Group (Individual Placement and Support) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ekman 60 Faces Test total score changes | Minimum 0 and maximum 60. Between 20-40 years average 51.43, cut-off point 45, below deficit. Between 40-60 years, average 51.20, cut-off point 43, below deficit. | At baseline and after 1 year treatment | 
| Hinting Task total score changes | Total 1 minimum 0 and maximum 20. Total 2 minimum 0 and maximum 10. Cut-off point 18, less deficit. | At baseline and after 1 year treatment | 
| Happé Strange Stories Test total score changes | Total control minimum 0 and maximum 16. Total theory of mind minimum 0 and maximum 16. Cut-off point 14, below the deficit. | At baseline and after 1 year treatment | 
| Faux Pas Recognition Test total score changes | FP stories and C questions, C stories and FP questions and C stories and C questions minimum 0 and maximum 20. FP stories and FP questions minimum 0 and maximum 60. Cut-off point without errors 54 and with errors 48, lower deficit scores. | At baseline and after 1 year treatment | 
| Ambiguous Intentions and Hostility Questionnaire total score changes | Hostility, anger, guilt and aggression minimum 1 and maximum 5. Intentionality minimum 1 and maximum 6. Calculate the mean. | At baseline and after 1 year treatment | 
| Movie for the Assessment of Social Cognition total score changes | Minimum 0 and maximum 42. | At baseline and after 1 year treatment | 
| Screening for Cognitive Impairment in Psychiatry (SCIP-S) total score changes | Minimum 1 and maximum 99, very low range 1-2.5 and low range 2.5-15. The deterioration depends on the scale. | At baseline and after 1 year treatment | 
| Positive and Negative Symptom Scale (PANSS) total score changes | Positive and negative subscales minimum 7 and maximum 49. General psychopathology subscale minimum 16 and maximum 112. Composite subscale minimum -42 and maximum +42. Categorize subtype positive >0 and negative <0. | At baseline and after 1 year treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Employment | Number of jobs | Up to 12 months in 2021 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rehabilitation, schizophrenia, emotional adjustment, theory of mind