Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
92 participants
INTERVENTIONAL
2009-08-31
2011-08-31
Brief Summary
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To evaluate the efficacy of social skills training in reducing negative symptoms in patients with refractory schizophrenia, in comparison with control (befriending group).
Secondary:
To evaluate changes in social functioning.
To evaluate the effect of SST in other dimensions of psychopathology: positive symptoms, depression and general psychopathology.
To evaluate the impact of SST in cognition.
Hypothesis Social skills training is more effective than control group (Befriending) in reducing negative symptoms in patients with refractory schizophrenia.
Detailed Description
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The objective of this study is to evaluate the efficacy of Social Skills Training on negative symptoms in patients with refractory schizophrenia by means of a randomized, single-blind controlled trial with the duration of a year, including, follow up.
This study will be conducted in two groups: one group will receive social skills training (N=46) and a control group (N=46) will attend the same number of sessions, but without intervention of the therapists (befriending).
Psychiatric, psychological and neuropsychological aspects will be evaluated at baseline, after 20 weeks and 6 months after the end of the intervention.
The scales that will be used for the psychiatric assessments are: PANSS (reduction of 20% in the negative subscale), CGI, CALGARY, SDS, and PSP, As well as the Social Skills Inventory IHS. The neuropsychological assessment will have groups of scales to measure: Attention, Memory, Executive Functions, Estimated Intellectual Efficiency and a ToM. For statistical , the repeated measure ANOVA will be used, as well as the effect size and number needed to treat.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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1
Group of behaviors by which someone express feelings, attitudes, wishes,opinions and rights , in an adequate manner regarding situation and context.
Social skills are the substrate for social competence, which is the ability to find and legitimate relevant and personal goals
Social Skills Training
A program developed during 20 weeks according to adapted BELLACK 's manual (1997),including sessions in group one hour per week.
2
Control group will attend the same number of sessions, but without intervention of the therapists
Social Skills Training
A program developed during 20 weeks according to adapted BELLACK 's manual (1997),including sessions in group one hour per week.
Interventions
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Social Skills Training
A program developed during 20 weeks according to adapted BELLACK 's manual (1997),including sessions in group one hour per week.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age between 18 and 55 years old.
* A minimum of 16 in negative subscale of PANSS.
* A score 4 in at least 3 of the following symptoms:
* blunted affect
* social withdrawal
* rapport
* passive social withdrawal
* lack of spontaneity
* motor retardation
* active social avoidance
* Stable disease, in use of clozapine, without recent hospitalization.
Exclusion Criteria
* Axis I comorbidity.
* History of head trauma or neurological disease.
* Clinical problems which can affect central nervous system.
* Mental retardation.
* Patients treated with other antipsychotic than clozapine.
* Patients who underwent other psychosocial treatments.
18 Years
55 Years
ALL
No
Sponsors
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University of Sao Paulo
OTHER
Responsible Party
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Instituto de Psiquiatria da Faculdade de Medicina da Universidade de São Paulo
Principal Investigators
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Helio Elkis, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Departamento de Psiquiatria da FMUSP
Locations
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Instituto de Psiquiatria do HCFMUSP
São Paulo, São Paulo, Brazil
Countries
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Central Contacts
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Facility Contacts
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Silvia Scemes, BSc
Role: primary
Other Identifiers
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SST
Identifier Type: -
Identifier Source: org_study_id