SchizophreniaNCT00069433
Enhancing the Outcome of Skills Training for People With Schizophrenia
A study testing Social skills and symptom management training in people with Schizophrenia, run by New York State Psychiatric Institute at 2 sites in United States.
Trial summary
This study will determine the effectiveness of skills training in people with schizophrenia and the applicability of the acquired skills in the "real world." Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Social skills and symptom management training
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2001to Nov 2005
- 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 or schizoaffective disorder for > 5 years
- Use of stable dose risperidone, olanzapine, or quetiapine for at least 1 month with no planned medication changes
- Social Behavior Scale (SBS) score > 45
- Willing and able to provide informed consent
Who cannot join
- Intelligence Quotient < 70
- Use of more than one antipsychotic medication
- Use of benzodiazepines, tricyclic antidepressants, or anticholinergic medication commonly used to treat extrapyramidal symptoms
- Diagnostic and Statistical Manual (DSM)-IV criteria for alcohol or other substance dependence
- History of any traumatic brain injury leading to loss of consciousness for > 30 minutes
- Diagnosis of a comorbid medical condition that could interfere with antipsychotic medication treatment or the ability to complete the study
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Hall-Brooke-The Center
Bridgeport, Connecticut, 06606
Hall-Brooke Behavioral Health Services
Westport, Connecticut, 06880
About this study
Official title: Skills Training for Schizophrenia: Enhancing Outcomes
This study will determine the effectiveness of skills training in people with schizophrenia and the applicability of the acquired skills in the "real world."
Read the detailed description
People with schizophrenia have a large number of social and symptom management training programs available to them. Studies suggest that these training programs are effective, but their generalizability and effectiveness in outpatient settings has not been thoroughly examined. This study will examine the treatment outcomes of a skills training approach in schizophrenic individuals taking antipsychotic medication.
Participants taking stable doses of risperidone, olanzapine, or quetiapine will be randomly assigned to receive either intensive symptom management and social skills training or group therapy for 12 months. A verbal memory test will be used to stratify the randomization procedure and to control for neurocognitive functioning.
- Conditions
- Schizophrenia
- Being tested
- Social skills and symptom management training
- Keywords
- Psychotic Disorders
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social skills and symptom management trainingProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2003 (estimated)
- Study startApr 2001
- Primary completionNov 2005
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00069433
- Sponsor's protocol ID
- #4339
- Other IDs
- R01MH066362, DSIR AT-SP
- Status last verified
- Sep 2013
- First submitted
- 24 Sep 2003
- Last updated
- 24 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skills Training for Schizophrenia: Enhancing Outcomes
- ClinicalTrials.gov ID
- NCT00069433
- Acronym / sponsor ID
- #4339
- Conditions
- Schizophrenia
- Keywords
- Psychotic Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Apr 2001
- Primary completion
- Nov 2005 (actual)
- Study completion
- Nov 2005 (actual)
- First posted
- 9 Oct 2003 (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.
This study will determine the effectiveness of skills training in people with schizophrenia and the applicability of the acquired skills in the "real world."
Detailed description
People with schizophrenia have a large number of social and symptom management training programs available to them. Studies suggest that these training programs are effective, but their generalizability and effectiveness in outpatient settings has not been thoroughly examined. This study will examine the treatment outcomes of a skills training approach in schizophrenic individuals taking antipsychotic medication.
Participants taking stable doses of risperidone, olanzapine, or quetiapine will be randomly assigned to receive either intensive symptom management and social skills training or group therapy for 12 months. A verbal memory test will be used to stratify the randomization procedure and to control for neurocognitive functioning.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Diagnosis of schizophrenia or schizoaffective disorder for > 5 years
- Use of stable dose risperidone, olanzapine, or quetiapine for at least 1 month with no planned medication changes
- Social Behavior Scale (SBS) score > 45
- Willing and able to provide informed consent
Key exclusion criteria (6 listed)
- Intelligence Quotient < 70
- Use of more than one antipsychotic medication
- Use of benzodiazepines, tricyclic antidepressants, or anticholinergic medication commonly used to treat extrapyramidal symptoms
- Diagnostic and Statistical Manual (DSM)-IV criteria for alcohol or other substance dependence
- History of any traumatic brain injury leading to loss of consciousness for > 30 minutes
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 and symptom management training | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Social skills and symptom management training in people with Schizophrenia, run by New York State Psychiatric Institute at 2 sites in United States.
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 4 inclusion and 6 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: finished, as of the sponsor's last update on 24 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
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 24 Sep 2013.