Social Skills Training in Refractory Schizophrenia (SST)

University of Sao Paulo

Status: Unknown

Conditions: Schizophrenia and Disorders With Psychotic Features

Treatments: Behavioral: Social Skills Training

Study type: Interventional

Funder types: Other

Identifiers

NCT00791882

SST

Details and patient eligibility

About

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.

Full 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.

Enrollment: 92 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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92 participants in 2 patient groups

1

Experimental group

Description:

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

Treatment:

Behavioral: Social Skills Training

2

No Intervention group

Description:

Control group will attend the same number of sessions, but without intervention of the therapists

Treatment:

Behavioral: Social Skills Training