Schizophrenia and Disorders With Psychotic FeaturesSSTNCT00791882
Social Skills Training in Refractory Schizophrenia
A study testing Social Skills Training in people with Schizophrenia and Disorders With Psychotic Features, run by University of Sao Paulo at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Schizophrenia and Disorders With Psychotic Features
- What is being tested?
- Social Skills Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2009to Aug 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Show all 12Show fewer
- rapport
- passive social withdrawal
- lack of spontaneity
- motor retardation
- active social avoidance
- Stable disease, in use of clozapine, without recent hospitalization.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Instituto de Psiquiatria do HCFMUSP
São Paulo, São Paulo, 05403000
Silvia Scemes, BSc, 55 11 30697808, silviascemes@gmail.com
Helio Elkis, PhD MD
About this study
Official title: Evaluation of Social Skills Training in Reducing Negative Symptoms in Patients With Refractory Schizophrenia
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.
Read the 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.
- Being tested
- Social Skills Training
- Medical subject headings
- Schizophrenia Spectrum and Other Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social Skills TrainingBehavioural
Also called Social Skills Training and Control group without active intervention.
A program developed during 20 weeks according to adapted BELLACK 's manual (1997),including sessions in group one hour per week.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Social Skills Training |
| 2 | No intervention | Control group will attend the same number of sessions, but without intervention of the therapists Receives: Behavioral: Social Skills Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response: at least 20% decrease at PANSS - negative subscale after 20 weeks, in comparison with baseline, maintained at 26 weeks follow-up.
Measured: 20 weeks treatment
Secondary outcomes (1)
Improvement at PSP scores
Measured: 20 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2008 (estimated)
- Study startAug 2009
- Primary completionAug 2011 (estimated)
- Study completionAug 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schizophrenia and Disorders With Psychotic FeaturesStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Investigators
- Helio Elkis, MD PhD, Principal investigator, Departamento de Psiquiatria da FMUSP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00791882
- Sponsor's protocol ID
- SST
- Acronym
- SST
- Status last verified
- Nov 2009
- First submitted
- 14 Nov 2008
- Last updated
- 30 Nov 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Social Skills Training in Reducing Negative Symptoms in Patients With Refractory Schizophrenia
- ClinicalTrials.gov ID
- NCT00791882
- Acronym / sponsor ID
- SST / SST
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Aug 2011 (estimated)
- Study completion
- Aug 2011 (estimated)
- First posted
- 17 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Social Skills TrainingGroup 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 |
| 2 | No intervention | Behavioral: Social Skills TrainingControl group will attend the same number of sessions, but without intervention of the therapists |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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:
- Stable disease, in use of clozapine, without recent hospitalization.
Key exclusion criteria (7 listed)
- Comorbid substance use.
- Axis I comorbidity.
- History of head trauma or neurological disease.
- Clinical problems which can affect central nervous system.
- Mental retardation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Social Skills TrainingAlso: Social Skills Training and Control group without active intervention.A program developed during 20 weeks according to adapted BELLACK 's manual (1997),including sessions in group one hour per week. | Behavioural | 1, 2 |
Primary outcome
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
1 secondary outcome
Improvement at PSP scores
Time frame: 20 weeks after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helio Elkis, MD PhD principal investigator
Departamento de Psiquiatria da FMUSP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Social Skills Training in people with Schizophrenia and Disorders With Psychotic Features, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Helio Elkis, MD PhD (+ 55 11 30697531, helkis@usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2009.