SchizophreniaNCT00339170
Cognitive Training and Enhanced Supported Employment in Schizophrenia
A study testing Computer-Based Cognitive Enhancement Training Program and Work Therapy Program in people with Schizophrenia, run by Yale University at 1 site in United States.
Trial summary
This study will evaluate the effectiveness of a computer-based cognitive enhancement program plus a work therapy program at improving productivity, work performance, and quality of life in schizophrenic individuals. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Computer-Based Cognitive Enhancement Training Program and Work Therapy Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2000to Jul 2013
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of schizophrenia or schizoaffective disorder
Who cannot join
- Hospitalized in the 30 days prior to study entry
- Homeless in the 30 days prior to study entry
- Changed medications in the 30 days prior to study entry
- Substance abuse in the 30 days prior to study entry
- History of head trauma
Trial locations and contacts
1 site in 1 country.
United States1 site
Connecticut Mental Health Center
New Haven, Connecticut, 06519
About this study
Official title: Cognitive Training and Enhanced Supported Employment
This study will evaluate the effectiveness of a computer-based cognitive enhancement program plus a work therapy program at improving productivity, work performance, and quality of life in schizophrenic individuals.
Read the detailed description
Schizophrenia is a chronic, severe, and disabling brain disorder that affects 2.4 million people in the United States. Individuals with schizophrenia may have difficulties with cognitive functioning, including problems with attention, memory, and organizational thought processes. These factors can lead to decreased productivity and poor work performance, which may make holding a job difficult. Research has shown that certain types of psychological therapies, such as cognitive behavioral therapy, are useful in reducing the severity of schizophrenic symptoms. The purpose of this study is to determine whether a computer-based cognitive enhancement training program, in combination with a work therapy program, will enhance workplace performance, productivity, and quality of life in individuals with schizophrenia.
This study will enroll individuals with schizophrenia or schizoaffective disorder. Participants will undergo a cognitive assessment at baseline. They will then be randomly assigned to either a 12-month cognitive enhancement training program plus a 12-month work therapy program or a 12-month work therapy program alone. Participants in the cognitive enhancement training program will receive feedback on their cognitive strengths and weaknesses based on the outcomes of the baseline assessment. The training component will be comprised of 150 computer-based exercises that focus on improving memory, attention, and organizational skills. Participants will attend two weekly meetings: one will focus on providing feedback regarding goal-setting and problem-solving, and the other will focus on improving verbal skills and social information processing. Individuals taking part only in the work therapy program will attend two non-cognitive discussion groups per week. All participants will work up to 20 hours a week in an approved work environment, and will have access to appropriate support services. Following the end of the program, participants will have the option of working an additional 12 months. Schizophrenia symptoms, quality of life, and neuropsychological and rehabilitation effects will be assessed at the end of Years 1 and 2.
- Conditions
- Schizophrenia
- Being tested
- Computer-Based Cognitive Enhancement Training Program, Work Therapy Program
- Keywords
- Schizoaffective Disorder, Schizophrenic Disorders, Psychotic Disorders, Cognition
- 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.
Computer-Based Cognitive Enhancement Training ProgramBehavioural
Participants in the cognitive enhancement training program will receive feedback on their cognitive strengths and weaknesses based on the outcomes of the baseline assessment. The training component will be comprised of 150 computer-based exercises that focus on improving memory, attention, and organizational skills. Participants will attend two weekly meetings: one will focus on providing feedback regarding goal-setting and problem-solving, and the other will focus on improving verbal skills and social information processing.
Work Therapy ProgramBehavioural
Participants in the work therapy program will attend two non-cognitive discussion groups per week.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Participants receive a 12-month cognitive enhancement training program plus a 12-month work therapy program. Receives: Behavioral: Computer-Based Cognitive Enhancement Training Program; Behavioral: Work Therapy Program |
| 2 | Active comparator | Participants receive a 12-month work therapy program alone. Receives: Behavioral: Work Therapy Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Schizophrenia symptoms
Measured: Measured at Year 1
Vocational functioning
Measured: Measured at Year 2
Schizophrenia symptoms
Measured: Measured at Year 2
Quality of life
Measured: Measured at Year 2
Quality of life
Measured: Measured at Year 1
Vocational functioning
Measured: Measured at Year 1
Secondary outcomes (4)
Number of hospitalizations
Measured: Measured at Year 1
Income
Measured: Measured at Year 1
Number of hospitalizations
Measured: Measured at Year 2
Income
Measured: Measured at Year 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2006 (estimated)
- Study startApr 2000
- Primary completionJun 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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
- Outcomes assessor
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Morris D. Bell, PhD, Principal investigator, Yale University School of Medicine, VA CT Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00339170
- Sponsor's protocol ID
- R01MH061493
- Other IDs
- R01MH061493, DSIR AT-RH
- Status last verified
- Apr 2016
- First submitted
- 16 Jun 2006
- Last updated
- 30 Mar 2020
- Results posted
- No
Publications
Bell, M.D., Bryson, G., Kaplan, E. Work rehabilitation in schizophrenia: cognitive predictors of best and worst performance. Schizophrenia Research. 1999; 36:322.
Bell M, Bryson G, Wexler BE. Cognitive remediation of working memory deficits: durability of training effects in severely impaired and less severely impaired schizophrenia. Acta Psychiatr Scand. 2003 Aug;108(2):101-9. doi: 10.1034/j.1600-0447.2003.00090.x.
PubMed 12823166Bell M, Bryson G, Greig T, Corcoran C, Wexler BE. Neurocognitive enhancement therapy with work therapy: effects on neuropsychological test performance. Arch Gen Psychiatry. 2001 Aug;58(8):763-8. doi: 10.1001/archpsyc.58.8.763.
PubMed 11483142Bell MD, Fiszdon J, Bryson G, Wexler BE. Effects of neurocognitive enhancement therapy in schizophrenia: normalisation of memory performance. Cogn Neuropsychiatry. 2004 Aug;9(3):199-211. doi: 10.1080/13546800344000084.
PubMed 16571581Greig T, Zito W, Bell MD. Rehab rounds: A hybrid transitional and supported employment program. Psychiatr Serv. 2004 Mar;55(3):240-2. doi: 10.1176/appi.ps.55.3.240. No abstract available.
PubMed 15001722Bell, M.D., Brsyon, G.J. Work rehabilitation in schizophrenia: cognitive predictors of best and worst performance. Schizophrenia Research. 2001;36:322.
Bell, M.D, Brsyon, G.J , Fiszdon, J., Greig, T.C., Wexler, B.E. Neurocognitive enhancement therapy and work therapy in schizophrenia: Work outcomes at 6 months and 12 month follow-up. Biological Psychiatry. 2004; 55: 1S-242S.
Greig, T.C., Nicholls, S.S., Bryson, G.J., Bell, M.D. The Vocational Cognitive Rating Scale: A Scale for the Assessment of Cognitive Functioning at Work for Clients With Severe Mental Illness. The Journal of Vocational Rehabilitation. 2004; 21: 71-81.
Bryson, G & Bell, MD. Work performance improvement in schizophrenia: Symptom and cognitive predictors. Schizophrenia Resarch. 2001; 49: 258.
Bell MD, Choi KH, Dyer C, Wexler BE. Benefits of cognitive remediation and supported employment for schizophrenia patients with poor community functioning. Psychiatr Serv. 2014 Apr 1;65(4):469-75. doi: 10.1176/appi.ps.201200505.
PubMed 24382594Surti TS, Corbera S, Bell MD, Wexler BE. Successful computer-based visual training specifically predicts visual memory enhancement over verbal memory improvement in schizophrenia. Schizophr Res. 2011 Nov;132(2-3):131-4. doi: 10.1016/j.schres.2011.06.031. Epub 2011 Jul 27.
PubMed 21795025
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Training and Enhanced Supported Employment
- ClinicalTrials.gov ID
- NCT00339170
- Acronym / sponsor ID
- R01MH061493
- Conditions
- Schizophrenia
- Keywords
- Schizoaffective Disorder, Schizophrenic Disorders, Psychotic Disorders, Cognition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Apr 2000
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 20 Jun 2006 (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 evaluate the effectiveness of a computer-based cognitive enhancement program plus a work therapy program at improving productivity, work performance, and quality of life in schizophrenic individuals.
Detailed description
Schizophrenia is a chronic, severe, and disabling brain disorder that affects 2.4 million people in the United States. Individuals with schizophrenia may have difficulties with cognitive functioning, including problems with attention, memory, and organizational thought processes. These factors can lead to decreased productivity and poor work performance, which may make holding a job difficult. Research has shown that certain types of psychological therapies, such as cognitive behavioral therapy, are useful in reducing the severity of schizophrenic symptoms. The purpose of this study is to determine whether a computer-based cognitive enhancement training program, in combination with a work therapy program, will enhance workplace performance, productivity, and quality of life in individuals with schizophrenia.
This study will enroll individuals with schizophrenia or schizoaffective disorder. Participants will undergo a cognitive assessment at baseline. They will then be randomly assigned to either a 12-month cognitive enhancement training program plus a 12-month work therapy program or a 12-month work therapy program alone. Participants in the cognitive enhancement training program will receive feedback on their cognitive strengths and weaknesses based on the outcomes of the baseline assessment. The training component will be comprised of 150 computer-based exercises that focus on improving memory, attention, and organizational skills. Participants will attend two weekly meetings: one will focus on providing feedback regarding goal-setting and problem-solving, and the other will focus on improving verbal skills and social information processing. Individuals taking part only in the work therapy program will attend two non-cognitive discussion groups per week. All participants will work up to 20 hours a week in an approved work environment, and will have access to appropriate support services. Following the end of the program, participants will have the option of working an additional 12 months. Schizophrenia symptoms, quality of life, and neuropsychological and rehabilitation effects will be assessed at the end of Years 1 and 2.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Computer-Based Cognitive Enhancement Training Program, Behavioral: Work Therapy ProgramParticipants receive a 12-month cognitive enhancement training program plus a 12-month work therapy program. |
| 2 | Active comparator | Behavioral: Work Therapy ProgramParticipants receive a 12-month work therapy program alone. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of schizophrenia or schizoaffective disorder
Key exclusion criteria (5 listed)
- Hospitalized in the 30 days prior to study entry
- Homeless in the 30 days prior to study entry
- Changed medications in the 30 days prior to study entry
- Substance abuse in the 30 days prior to study entry
- History of head trauma
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 |
|---|---|---|
| Computer-Based Cognitive Enhancement Training ProgramParticipants in the cognitive enhancement training program will receive feedback on their cognitive strengths and weaknesses based on the outcomes of the baseline assessment. The training component will be comprised of 150 computer-based exercises that focus on improving memory, attention, and organizational skills. Participants will attend two weekly meetings: one will focus on providing feedback regarding goal-setting and problem-solving, and the other will focus on improving verbal skills and social information processing. | Behavioural | 1 |
| Work Therapy ProgramParticipants in the work therapy program will attend two non-cognitive discussion groups per week. | Behavioural | 1, 2 |
Primary outcome
Schizophrenia symptoms
Time frame: Measured at Year 1
Vocational functioning
Time frame: Measured at Year 2
Schizophrenia symptoms
Time frame: Measured at Year 2
Quality of life
Time frame: Measured at Year 2
Quality of life
Time frame: Measured at Year 1
Vocational functioning
Time frame: Measured at Year 1
4 secondary outcomes
Number of hospitalizations
Time frame: Measured at Year 1
Income
Time frame: Measured at Year 1
Number of hospitalizations
Time frame: Measured at Year 2
Income
Time frame: Measured at Year 2
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 30 Mar 2020.
- BackgroundBell, M.D., Bryson, G., Kaplan, E. Work rehabilitation in schizophrenia: cognitive predictors of best and worst performance. Schizophrenia Research. 1999; 36:322.
- Background: PubMed 12823166Bell M, Bryson G, Wexler BE. Cognitive remediation of working memory deficits: durability of training effects in severely impaired and less severely impaired schizophrenia. Acta Psychiatr Scand. 2003 Aug;108(2):101-9. doi: 10.1034/j.1600-0447.2003.00090.x.
- Background: PubMed 11483142Bell M, Bryson G, Greig T, Corcoran C, Wexler BE. Neurocognitive enhancement therapy with work therapy: effects on neuropsychological test performance. Arch Gen Psychiatry. 2001 Aug;58(8):763-8. doi: 10.1001/archpsyc.58.8.763.
- Background: PubMed 16571581Bell MD, Fiszdon J, Bryson G, Wexler BE. Effects of neurocognitive enhancement therapy in schizophrenia: normalisation of memory performance. Cogn Neuropsychiatry. 2004 Aug;9(3):199-211. doi: 10.1080/13546800344000084.
- Background: PubMed 15001722Greig T, Zito W, Bell MD. Rehab rounds: A hybrid transitional and supported employment program. Psychiatr Serv. 2004 Mar;55(3):240-2. doi: 10.1176/appi.ps.55.3.240. No abstract available.
- BackgroundBell, M.D., Brsyon, G.J. Work rehabilitation in schizophrenia: cognitive predictors of best and worst performance. Schizophrenia Research. 2001;36:322.
- BackgroundBell, M.D, Brsyon, G.J , Fiszdon, J., Greig, T.C., Wexler, B.E. Neurocognitive enhancement therapy and work therapy in schizophrenia: Work outcomes at 6 months and 12 month follow-up. Biological Psychiatry. 2004; 55: 1S-242S.
- BackgroundGreig, T.C., Nicholls, S.S., Bryson, G.J., Bell, M.D. The Vocational Cognitive Rating Scale: A Scale for the Assessment of Cognitive Functioning at Work for Clients With Severe Mental Illness. The Journal of Vocational Rehabilitation. 2004; 21: 71-81.
- BackgroundBryson, G & Bell, MD. Work performance improvement in schizophrenia: Symptom and cognitive predictors. Schizophrenia Resarch. 2001; 49: 258.
- Derived from this study: PubMed 24382594Bell MD, Choi KH, Dyer C, Wexler BE. Benefits of cognitive remediation and supported employment for schizophrenia patients with poor community functioning. Psychiatr Serv. 2014 Apr 1;65(4):469-75. doi: 10.1176/appi.ps.201200505.
- Derived from this study: PubMed 21795025Surti TS, Corbera S, Bell MD, Wexler BE. Successful computer-based visual training specifically predicts visual memory enhancement over verbal memory improvement in schizophrenia. Schizophr Res. 2011 Nov;132(2-3):131-4. doi: 10.1016/j.schres.2011.06.031. Epub 2011 Jul 27.
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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.
Morris D. Bell, PhD principal investigator
Yale University School of Medicine, VA CT Healthcare System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computer-Based Cognitive Enhancement Training Program and Work Therapy Program in people with Schizophrenia, run by Yale University 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 1 inclusion and 5 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 30 Mar 2020. 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?
Schizophrenia symptoms (time frame: Measured at Year 1). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00339170, which also lists 11 linked publications.
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 Mar 2020.