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SST: Social Skills Training in Refractory Schizophrenia

Sponsor
University of Sao Paulo (Other)
Overall Status
Unknown status
CT.gov ID
NCT00791882
Collaborator
(none)
92
Enrollment
1
Location
2
Arms
24
Duration (Months)
3.8
Patients Per Site Per Month

Study Details

Study Description

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
  • Behavioral: Social Skills Training
 N/A

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 Design

Study Type:
Interventional
Anticipated 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 :
Aug 1, 2009
Anticipated Primary Completion Date :
Aug 1, 2011
Anticipated Study Completion Date :
Aug 1, 2011

Arms and Interventions

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.

    		•

    Outcome Measures

    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. [20 weeks treatment]

    Secondary Outcome Measures

    1. Improvement at PSP scores [20 weeks after treatment]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Instituto de Psiquiatria do HCFMUSP São Paulo Brazil 05403000

    Sponsors and Collaborators

    • University of Sao Paulo

    Investigators

    • Principal Investigator: Helio Elkis, MD PhD, Departamento de Psiquiatria da FMUSP

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00791882
    Other Study ID Numbers:
    • SST
    First Posted:
    Nov 17, 2008
    Last Update Posted:
    Nov 30, 2009
    Last Verified:
    Nov 1, 2009
    Additional relevant MeSH terms:
    Schizophrenia
    Schizophrenia Spectrum and Other Psychotic Disorders

    Study Results

    No Results Posted as of Nov 30, 2009