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Social Skills Training in Refractory Schizophrenia (SST)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by University of Sao Paulo.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT00791882
First received: November 14, 2008
Last updated: November 27, 2009
Last verified: November 2009
History of Changes
  Purpose

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.


Condition Intervention
Schizophrenia and Disorders With Psychotic Features
 Behavioral: Social Skills Training

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Evaluation of Social Skills Training in Reducing Negative Symptoms in Patients With Refractory Schizophrenia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Response: at least 20% decrease at PANSS - negative subscale after 20 weeks, in comparison with baseline, maintained at 26 weeks follow-up. [ Time Frame: 20 weeks treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improvement at PSP scores [ Time Frame: 20 weeks after treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 92
Study Start Date: August 2009
Estimated Study Completion Date: August 2011
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Social Skills Training and Control group without active intervention.

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

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00791882

Contacts
Contact: Helio Elkis, MD PhD + 55 11 30697531 helkis@usp.br
Contact: Silvia Scemes, BSc + 55 11 30697808 silviascemes@gmail.com

Locations
Brazil
Instituto de Psiquiatria do HCFMUSP Recruiting
São Paulo, Brazil, 05403000
Contact: Silvia Scemes, BSc     55 11 30697808     silviascemes@gmail.com    
Principal Investigator: Helio Elkis, PhD MD            
Sponsors and Collaborators
University of Sao Paulo
Investigators
Principal Investigator: Helio Elkis, MD PhD Departamento de Psiquiatria da FMUSP
  More Information

No publications provided

Responsible Party: Helio Elkis MD PhD, Instituto de Psiquiatria da Faculdade de Medicina da Universidade de São Paulo
ClinicalTrials.gov Identifier: NCT00791882     History of Changes
Other Study ID Numbers: SST
Study First Received: November 14, 2008
Last Updated: November 27, 2009
Health Authority: Brazil: Ministry of Health
Brazil: National Committee of Ethics in Research

Additional relevant MeSH terms:
Mental Disorders
Psychotic Disorders
Schizophrenia
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on June 17, 2013