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Social Skills Training in Refractory Schizophrenia (SST)

Primary Purpose

Schizophrenia and Disorders With Psychotic Features

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Social Skills Training
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia and Disorders With Psychotic Features

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept 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.

Sites / Locations

  • Instituto de Psiquiatria do HCFMUSPRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

1

2

Arm 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

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

Outcomes

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.

Secondary Outcome Measures

Improvement at PSP scores

Full Information

First Posted
November 14, 2008
Last Updated
November 27, 2009
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT00791882
Brief Title
Social Skills Training in Refractory Schizophrenia
Acronym
SST
Official Title
Evaluation of Social Skills Training in Reducing Negative Symptoms in Patients With Refractory Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
November 2009
Overall Recruitment Status
Unknown status
Study Start Date
August 2009 (undefined)
Primary Completion Date
August 2011 (Anticipated)
Study Completion Date
August 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University of Sao Paulo

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia and Disorders With Psychotic Features

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
92 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm 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
Arm Title
2
Arm Type
No Intervention
Arm Description
Control group will attend the same number of sessions, but without intervention of the therapists
Intervention Type
Behavioral
Intervention Name(s)
Social Skills Training
Other Intervention Name(s)
Social Skills Training and Control group without active intervention.
Intervention Description
A program developed during 20 weeks according to adapted BELLACK 's manual (1997),including sessions in group one hour per week.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Improvement at PSP scores
Time Frame
20 weeks after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Helio Elkis, MD PhD
Phone
+ 55 11 30697531
Email
helkis@usp.br
First Name & Middle Initial & Last Name or Official Title & Degree
Silvia Scemes, BSc
Phone
+ 55 11 30697808
Email
silviascemes@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helio Elkis, MD PhD
Organizational Affiliation
Departamento de Psiquiatria da FMUSP
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto de Psiquiatria do HCFMUSP
City
São Paulo
ZIP/Postal Code
05403000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Silvia Scemes, BSc
Phone
55 11 30697808
Email
silviascemes@gmail.com
First Name & Middle Initial & Last Name & Degree
Helio Elkis, PhD MD

12. IPD Sharing Statement

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Social Skills Training in Refractory Schizophrenia

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