Social Skills Training in Refractory Schizophrenia (SST)

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.

Study Overview

• Status: Unknown
• Conditions: Schizophrenia and Disorders With Psychotic Features
• Intervention / Treatment: Behavioral: Social Skills Training

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.

• Study Type: Interventional
• Enrollment (Anticipated): 92
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Helio Elkis, MD PhD; Phone Number: + 55 11 30697531; Email: helkis@usp.br
• Study Contact Backup: Name: Silvia Scemes, BSc; Phone Number: + 55 11 30697808; Email: silviascemes@gmail.com

Study Locations

• Brazil
  • São Paulo, Brazil, 05403000
    • Recruiting
    • Instituto de Psiquiatria do HCFMUSP
    • Contact: Silvia Scemes, BSc; Phone Number: 55 11 30697808; Email: silviascemes@gmail.com
    • Principal Investigator: Helio Elkis, PhD MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	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.; Other Names: Social Skills Training and Control group without active intervention.
No Intervention: 2; Control group will attend the same number of sessions, but without intervention of the therapists	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.; Other Names: Social Skills Training and Control group without active intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Time Frame
Improvement at PSP scores	20 weeks after treatment

Collaborators and Investigators

• Sponsor: University of Sao Paulo
• Investigators: Principal Investigator: Helio Elkis, MD PhD, Departamento de Psiquiatria da FMUSP

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (Anticipated): August 1, 2011
• Study Completion (Anticipated): August 1, 2011

Study Registration Dates

• First Submitted: November 14, 2008
• First Submitted That Met QC Criteria: November 14, 2008
• First Posted (Estimate): November 17, 2008

Study Record Updates

• Last Update Posted (Estimate): November 30, 2009
• Last Update Submitted That Met QC Criteria: November 27, 2009
• Last Verified: November 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia; Schizophrenia Spectrum and Other Psychotic Disorders
• Other Study ID Numbers: SST