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Evaluation of Social Skills Training in Reducing Negative Symptoms in Patients With Refractory Schizophrenia
Objective Primary: 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.
In schizophrenia positive symptoms can be improved with an antipsychotic treatment. However there is a subgroup of patients who have a predominance of persistent negative symptoms that do not respond to antipsychotic treatment, such as blunted affect , emotional and social withdrawal, and there is evidence that such symptoms can improve with psychosocial interventions. 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.
Age
18 - 55 years
Sex
ALL
Healthy Volunteers
No
Instituto de Psiquiatria do HCFMUSP
São Paulo, São Paulo, Brazil
Start Date
August 1, 2009
Primary Completion Date
August 1, 2011
Completion Date
August 1, 2011
Last Updated
November 30, 2009
92
ESTIMATED participants
Social Skills Training
BEHAVIORAL
Lead Sponsor
University of Sao Paulo
NCT06939088
NCT02928965
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT02307396