Social Skills Training in Refractory Schizophrenia

NCT00791882 | Unknown DMC

• 1 other identifier: SST
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia and Disorders With Psychotic Features

Outcome Measures

Primary Outcomes (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 Outcomes (1)

• Improvement at PSP scores

  20 weeks after treatment

Study Arms (2)

1

EXPERIMENTAL

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

2

NO INTERVENTION

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

Behavioral: Social Skills Training

Interventions

Social Skills Training BEHAVIORAL

A program developed during 20 weeks according to adapted BELLACK 's manual (1997),including sessions in group one hour per week.

Also known as: Social Skills Training and Control group without active intervention.

1; 2

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Instituto de Psiquiatria do HCFMUSP

São Paulo, São Paulo, 05403000, Brazil

RECRUITING

MeSH Terms

Conditions

Schizophrenia Spectrum and Other Psychotic Disorders

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Helio Elkis, MD PhD

  Departamento de Psiquiatria da FMUSP

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Helio Elkis, MD PhD

CONTACT

+ 55 11 30697531; helkis@usp.br

Silvia Scemes, BSc

CONTACT

+ 55 11 30697808; silviascemes@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 14, 2008
• First Posted: November 17, 2008
• Study Start: August 1, 2009
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: November 30, 2009

Record last verified: 2009-11

Locations

BR (1)