Clinical trial NCT00791882: Social Skills Training in Refractory Schizophrenia
Official title: Evaluation of Social Skills Training in Reducing Negative Symptoms in Patients With Refractory Schizophrenia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Schizophrenia and Disorders With Psychotic Features
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2008-11-17
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Response: at least 20% decrease at PANSS - negative subscale after 20 weeks, in comparison with baseline, maintained at 26 weeks follow-up.
timeFrame: 20 weeks treatment
Secondary outcomes:
measure: Improvement at PSP scores
timeFrame: 20 weeks after treatment
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Instituto de Psiquiatria do HCFMUSP
Study officials:
affiliation: Departamento de Psiquiatria da FMUSP
name: Helio Elkis, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: