SchizophreniaNCT00223535
Cognitive Remediation and Social Skills Training in Schizophrenia
A study testing Cognitive Remediation and Social Skills Training in people with Schizophrenia and Schizoaffective, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial summary
The purpose of this study is to examine whether patients who participate in cognitive remediation prior to a skills training program learn and perform the skills better than patients who do not participate in cognitive remediation. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Schizophrenia, Schizoaffective
- What is being tested?
- Cognitive Remediation and Social Skills Training
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2003to Mar 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of schizophrenia/schizoaffective disorder
- currently receiving treatment with an atypical antipsychotic medication
- between the ages of 18 and 60 years
- speak English as their primary language
- has at least a 6th grade level of reading (WRAT) Exclusion Criteria
- no current diagnosis of substance abuse or dependence
- no documented history of head injury, epilepsy or mental retardation.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to examine whether patients who participate in cognitive remediation prior to a skills training program learn and perform the skills better than patients who do not participate in cognitive remediation.
Read the detailed description
Subjects are 40 stable outpatients with schizophrenia or schizoaffective disorder who are receiving medication and routine follow-up care at community clinics in San Antonio, Texas.
Patients receive baseline assessments and then are randomly assigned to either Cognitive Remediation (CR) or Keyboarding Skills (KS) for a period of 8 weeks. Following 8 weeks of treatment in either CR or KS, all patients participated in Social Skills Training (SST) for a period of 8 weeks. Assessments conducted by raters blinded to treatment condition are repeated following either remediation or control treatment, and again following SST.
Treatment groups Cognitive Remediation (CR) -- The CR program is based upon teaching techniques developed within educational psychology that promote intrinsic motivation and task engagement. The program uses existing computer software packages (e.g., Oregon Trail) with engaging story lines or activities, and built-in reinforcement of correct responses to help patients with schizophrenia develop attention, memory, planning, and problem-solving skills. CR is delivered in a computer lab setting with a facilitator present to assist patients.
Keyboarding Skills (KS) -- Control Treatment: The control treatment is an engaging self-paced software program designed to teach typing skills. KS is delivered in a computer lab setting with a facilitator present.
Both the KS and CR are administered in small groups of three to five patients each.
Social Skills Training (SST) -- SST is a manual-driven, behavioral rehabilitation program teaching basic conversation and social problem-solving skills (Bellack et al., 1997). SST runs for 8 weeks and is conducted in small groups that meet twice weekly.
- Conditions
- Schizophrenia, Schizoaffective
- Being tested
- Cognitive Remediation, Social Skills Training
- Keywords
- Schizophrenia, Cognitive Remediation, Social Skills Training, Psychosocial
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive RemediationBehavioural
Social Skills TrainingBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Scores on tests of cognitive functioning
Secondary outcomes (1)
Outcomes on tests of social functioning after SST
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startFeb 2003
- Study completionMar 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.
- More trials run by The University of Texas Health Science Center at San AntonioThe 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
- Enrolment
- 40 participants
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Alliance for Research on Schizophrenia and Depression
- Investigators
- Dawn I Velligan, Ph.D., Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00223535
- Sponsor's protocol ID
- 012-0013-164
- Status last verified
- Sep 2005
- First submitted
- 14 Sep 2005
- Last updated
- 22 Sep 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Remediation and Social Skills Training in Schizophrenia
- ClinicalTrials.gov ID
- NCT00223535
- Acronym / sponsor ID
- 012-0013-164
- Conditions
- Schizophrenia, Schizoaffective
- Keywords
- Schizophrenia, Cognitive Remediation, Social Skills Training, Psychosocial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- National Alliance for Research on Schizophrenia and Depression
- Study start
- Feb 2003
- Study completion
- Mar 2005
- First posted
- 22 Sep 2005 (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.
The purpose of this study is to examine whether patients who participate in cognitive remediation prior to a skills training program learn and perform the skills better than patients who do not participate in cognitive remediation.
Detailed description
Subjects are 40 stable outpatients with schizophrenia or schizoaffective disorder who are receiving medication and routine follow-up care at community clinics in San Antonio, Texas.
Patients receive baseline assessments and then are randomly assigned to either Cognitive Remediation (CR) or Keyboarding Skills (KS) for a period of 8 weeks. Following 8 weeks of treatment in either CR or KS, all patients participated in Social Skills Training (SST) for a period of 8 weeks. Assessments conducted by raters blinded to treatment condition are repeated following either remediation or control treatment, and again following SST.
Treatment groups Cognitive Remediation (CR) -- The CR program is based upon teaching techniques developed within educational psychology that promote intrinsic motivation and task engagement. The program uses existing computer software packages (e.g., Oregon Trail) with engaging story lines or activities, and built-in reinforcement of correct responses to help patients with schizophrenia develop attention, memory, planning, and problem-solving skills. CR is delivered in a computer lab setting with a facilitator present to assist patients.
Keyboarding Skills (KS) -- Control Treatment: The control treatment is an engaging self-paced software program designed to teach typing skills. KS is delivered in a computer lab setting with a facilitator present.
Both the KS and CR are administered in small groups of three to five patients each.
Social Skills Training (SST) -- SST is a manual-driven, behavioral rehabilitation program teaching basic conversation and social problem-solving skills (Bellack et al., 1997). SST runs for 8 weeks and is conducted in small groups that meet twice weekly.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Diagnosis of schizophrenia/schizoaffective disorder
- currently receiving treatment with an atypical antipsychotic medication
- between the ages of 18 and 60 years
- speak English as their primary language
- has at least a 6th grade level of reading (WRAT) Exclusion Criteria
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Cognitive Remediation | Behavioural | – |
| Social Skills Training | Behavioural | – |
Primary outcome
Scores on tests of cognitive functioning
1 secondary outcome
Outcomes on tests of social functioning after SST
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 22 Sep 2005.
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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.
Dawn I Velligan, Ph.D. principal investigator
University of Texas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Remediation and Social Skills Training in people with Schizophrenia and Schizoaffective, run by The University of Texas Health Science Center at San Antonio at 1 site 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 7 inclusion and 0 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 22 Sep 2005. 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 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.
What does the primary outcome measure?
Scores on tests of cognitive functioning. 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 22 Sep 2005.