Social Skills Training in Refractory Schizophrenia

Schizophrenia and Disorders With Psychotic Features Clinical Trial

— SST  

Official title:

Evaluation of Social Skills Training in Reducing Negative Symptoms in Patients With Refractory Schizophrenia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00791882
• Other study ID #: SST
• Status: Recruiting
• Phase: N/A
• First received: November 14, 2008
• Last updated: November 27, 2009
• Start date: August 2009
• Est. completion date: August 2011

Study information

• Verified date: November 2009
• Source: University of Sao Paulo
• Contact: Helio Elkis, MD PhD
• Phone: + 55 11 30697531
• Email: helkis[@]usp.br
• Is FDA regulated: No
• Health authority: Brazil: Ministry of HealthBrazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 92
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Diagnosis of schizophrenia can´t not be over 10 years old.

• 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:

• Comorbid substance use.

• 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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia
• Schizophrenia and Disorders with Psychotic Features

Intervention

Behavioral:
• Social Skills Training
A program developed during 20 weeks according to adapted BELLACK 's manual (1997),including sessions in group one hour per week.

Locations

Country	Name	City	State
Brazil	Instituto de Psiquiatria do HCFMUSP	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response: at least 20% decrease at PANSS - negative subscale after 20 weeks, in comparison with baseline, maintained at 26 weeks follow-up.		20 weeks treatment	No
Secondary	Improvement at PSP scores		20 weeks after treatment	No