SchizophreniaPhase 2/3NCT00430560
Work Activity Augmented by Cognitive Rehabilitation for Schizophrenia
A Phase 2/3 study testing cognitive rehabilitation and work therapy in people with Schizophrenia and Schizoaffective Disorder, run by VA Office of Research and Development at 1 site in United States.
Trial summary
This research investigates the benefits of productive activity and cognitive rehabilitation for patients with schizophrenia. Key questions are: 1. does cognitive rehabilitation plus work activity produce better outcomes than work activity alone? 2. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder
- What is being tested?
- cognitive rehabilitation and work therapy
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2000to Oct 2015
- Phase
- Phase 2/3
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of schizophrenia or schizoaffective disorder
Who cannot join
- change in psychiatric medications or housing within 30 days of study intake
- episode of drug abuse within 30 days of study intake
- GAF score 30 or less
- known neurological disease or developmental disability
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Connecticut Healthcare System
West Haven, Connecticut, 06516
About this study
Official title: Work Activity Augmented by Cognitive Rehabilitation: Continuation and Follow-up
This research investigates the benefits of productive activity and cognitive rehabilitation for patients with schizophrenia. Key questions are:
- does cognitive rehabilitation plus work activity produce better outcomes than work activity alone?
- Is cognitive rehabilitation more helpful for individuals with moderate or greater cognitive impairment than for individuals without such impairment?
- Does cognitive rehabilitation reduce the dropout rate and increase participation in work activity for cognitively impaired subjects?
- What features of cognitive rehabilitation are most important for clinical and rehabilitation outcomes?
Read the detailed description
This is a randomized, matching study in which subjects are stratified by degree of cognitive impairment, then randomly assigned to one of two conditions: Work Services Only vs. Work Services plus cognitive rehabilitation. Longitudinal analysis of work activity, work performance, symptoms, quality of life, cognitive function and service utilization are made.
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Being tested
- cognitive rehabilitation, work therapy
- Keywords
- work therapy, cognitive rehabilitation, schizophrenia, schizoaffective disorder, treatment outcome
- 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.
cognitive rehabilitationBehavioural
Also called computer training
computer training
work therapyProcedure or surgery
Also called IWT
opportunity to work in carefully supervised hospital job
work therapyBehavioural
work therapy
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | work therapy Receives: Procedure: work therapy; Behavioral: work therapy |
| 2 | Experimental | work therapy plus cognitive remediation Receives: Behavioral: cognitive rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuropsychological test performance
Measured: data collection completed
Secondary outcomes (4)
Hours of productive activity
Measured: data collection completed
Hours worked
Measured: data collection completed
Quality of life
Measured: data collection completed
Psychiatric symptoms
Measured: data collection completed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2007 (estimated)
- Study startOct 2000
- Primary completionOct 2005
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- VA Connecticut Healthcare System
- Responsible party
- Sponsor
- Investigators
- Morris D Bell, Ph.D., Principal investigator, VA Connecticut Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00430560
- Sponsor's protocol ID
- D2356-R
- Other IDs
- MDB0003
- Status last verified
- Sep 2017
- First submitted
- 31 Jan 2007
- Last updated
- 11 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Wexler BE, Bell MD. Cognitive remediation and vocational rehabilitation for schizophrenia. Schizophr Bull. 2005 Oct;31(4):931-41. doi: 10.1093/schbul/sbi038. Epub 2005 Aug 3.
PubMed 16079390Bell 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 11483142Fiszdon JM, Cardenas AS, Bryson GJ, Bell MD. Predictors of remediation success on a trained memory task. J Nerv Ment Dis. 2005 Sep;193(9):602-8. doi: 10.1097/01.nmd.0000177790.23311.ba.
PubMed 16131943Fiszdon JM, Whelahan H, Bryson GJ, Wexler BE, Bell MD. Cognitive training of verbal memory using a dichotic listening paradigm: impact on symptoms and cognition. Acta Psychiatr Scand. 2005 Sep;112(3):187-93. doi: 10.1111/j.1600-0447.2005.00565.x.
PubMed 16095473Bell MD, Fiszdon JM, Greig TC, Bryson GJ. Can older people with schizophrenia benefit from work rehabilitation? J Nerv Ment Dis. 2005 May;193(5):293-301. doi: 10.1097/01.nmd.0000161688.47164.71.
PubMed 15870612Bell MD, Bryson GJ, Greig TC, Fiszdon JM, Wexler BE. Neurocognitive enhancement therapy with work therapy: Productivity outcomes at 6- and 12-month follow-ups. J Rehabil Res Dev. 2005 Nov-Dec;42(6):829-38. doi: 10.1682/jrrd.2005.03.0061.
PubMed 16680620Fiszdon JM, Choi J, Bryson GJ, Bell MD. Impact of intellectual status on response to cognitive task training in patients with schizophrenia. Schizophr Res. 2006 Oct;87(1-3):261-9. doi: 10.1016/j.schres.2006.04.011. Epub 2006 Jun 5.
PubMed 16737798Bell 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 16571581
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Work Activity Augmented by Cognitive Rehabilitation: Continuation and Follow-up
- ClinicalTrials.gov ID
- NCT00430560
- Acronym / sponsor ID
- D2356-R
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Keywords
- work therapy, cognitive rehabilitation, schizophrenia, schizoaffective disorder, treatment outcome
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- VA Connecticut Healthcare System
- Study start
- Oct 2000
- Primary completion
- Oct 2005 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 2 Feb 2007 (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 research investigates the benefits of productive activity and cognitive rehabilitation for patients with schizophrenia. Key questions are:
- does cognitive rehabilitation plus work activity produce better outcomes than work activity alone?
- Is cognitive rehabilitation more helpful for individuals with moderate or greater cognitive impairment than for individuals without such impairment?
- Does cognitive rehabilitation reduce the dropout rate and increase participation in work activity for cognitively impaired subjects?
- What features of cognitive rehabilitation are most important for clinical and rehabilitation outcomes?
Detailed description
This is a randomized, matching study in which subjects are stratified by degree of cognitive impairment, then randomly assigned to one of two conditions: Work Services Only vs. Work Services plus cognitive rehabilitation. Longitudinal analysis of work activity, work performance, symptoms, quality of life, cognitive function and service utilization are made.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: work therapy, Behavioral: work therapywork therapy |
| 2 | Experimental | Behavioral: cognitive rehabilitationwork therapy plus cognitive remediation |
Who may qualify
- Ages
- 18 to 65 years
- 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 (4 listed)
- change in psychiatric medications or housing within 30 days of study intake
- episode of drug abuse within 30 days of study intake
- GAF score 30 or less
- known neurological disease or developmental disability
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 rehabilitationAlso: computer trainingcomputer training | Behavioural | 2 |
| work therapyAlso: IWTopportunity to work in carefully supervised hospital job | Procedure or surgery | 1 |
| work therapywork therapy | Behavioural | 1 |
Primary outcome
Neuropsychological test performance
Time frame: data collection completed
4 secondary outcomes
Hours of productive activity
Time frame: data collection completed
Hours worked
Time frame: data collection completed
Quality of life
Time frame: data collection completed
Psychiatric symptoms
Time frame: data collection completed
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 11 Sep 2017.
- Background: PubMed 16079390Wexler BE, Bell MD. Cognitive remediation and vocational rehabilitation for schizophrenia. Schizophr Bull. 2005 Oct;31(4):931-41. doi: 10.1093/schbul/sbi038. Epub 2005 Aug 3.
- Results publication: 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.
- Results publication: 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.
- Results publication: PubMed 16131943Fiszdon JM, Cardenas AS, Bryson GJ, Bell MD. Predictors of remediation success on a trained memory task. J Nerv Ment Dis. 2005 Sep;193(9):602-8. doi: 10.1097/01.nmd.0000177790.23311.ba.
- Results publication: PubMed 16095473Fiszdon JM, Whelahan H, Bryson GJ, Wexler BE, Bell MD. Cognitive training of verbal memory using a dichotic listening paradigm: impact on symptoms and cognition. Acta Psychiatr Scand. 2005 Sep;112(3):187-93. doi: 10.1111/j.1600-0447.2005.00565.x.
- Results publication: PubMed 15870612Bell MD, Fiszdon JM, Greig TC, Bryson GJ. Can older people with schizophrenia benefit from work rehabilitation? J Nerv Ment Dis. 2005 May;193(5):293-301. doi: 10.1097/01.nmd.0000161688.47164.71.
- Results publication: PubMed 16680620Bell MD, Bryson GJ, Greig TC, Fiszdon JM, Wexler BE. Neurocognitive enhancement therapy with work therapy: Productivity outcomes at 6- and 12-month follow-ups. J Rehabil Res Dev. 2005 Nov-Dec;42(6):829-38. doi: 10.1682/jrrd.2005.03.0061.
- Results publication: PubMed 16737798Fiszdon JM, Choi J, Bryson GJ, Bell MD. Impact of intellectual status on response to cognitive task training in patients with schizophrenia. Schizophr Res. 2006 Oct;87(1-3):261-9. doi: 10.1016/j.schres.2006.04.011. Epub 2006 Jun 5.
- Results publication: 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.
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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, Ph.D. principal investigator
VA Connecticut Healthcare System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing cognitive rehabilitation and work therapy in people with Schizophrenia and Schizoaffective Disorder, run by VA Office of Research and Development 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 4 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 11 Sep 2017. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Neuropsychological test performance (time frame: data collection completed). 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 NCT00430560, which also lists 9 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 11 Sep 2017.