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Social Skills Training in Refractory Schizophrenia (SST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00791882
Recruitment Status : Unknown
Verified November 2009 by University of Sao Paulo.
Recruitment status was:  Recruiting
First Posted : November 17, 2008
Last Update Posted : November 30, 2009
Sponsor:
Information provided by:
University of Sao Paulo

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.


Condition or disease Intervention/treatment Phase
Schizophrenia and Disorders With Psychotic Features Behavioral: Social Skills Training Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Evaluation of Social Skills Training in Reducing Negative Symptoms in Patients With Refractory Schizophrenia
Study Start Date : August 2009
Estimated Primary Completion Date : August 2011
Estimated Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

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 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.




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Improvement at PSP scores [ Time Frame: 20 weeks after treatment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00791882


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

Locations
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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
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Principal Investigator: Helio Elkis, MD PhD Departamento de Psiquiatria da FMUSP
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Responsible Party: Helio Elkis MD PhD, Instituto de Psiquiatria da Faculdade de Medicina da Universidade de São Paulo
ClinicalTrials.gov Identifier: NCT00791882    
Other Study ID Numbers: SST
First Posted: November 17, 2008    Key Record Dates
Last Update Posted: November 30, 2009
Last Verified: November 2009
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders