SchizophreniaNCT00261794
Cognitive Remediation for Schizophrenia
A study testing computer-assisted cognitive remediation (CACR) in people with Schizophrenia, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the efficacy of an innovative, computer driven cognitive rehabilitation program for unemployed veterans with schizophrenia. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- computer-assisted cognitive remediation (CACR)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2004to Sep 2007
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Current DSM-IV diagnoses of schizophrenia or schizoaffective disorder
- Stable clinical course and antipsychotic treatment on a new generation antipsychotic other than clozapine and/or a dose of first generation antipsychotic equivalent to 10 mg. or less of haloperidol for one month prior to enrollment
- Age between 18 and 64 years
- Voluntary consent after receiving full information about the study
Who cannot join
- Documented history of neurological disorder or significant head trauma with extended loss of consciousness
- Physical limitations (e.g., with hearing or vision) that would interfere substantially with the use of computer-based exercises
- Current treatment with a first generation antipsychotic medication at a dose equivalent to more than 10 mg. of haloperidol
- Current treatment with benztropine mesylate at a daily does greater than 4 mg
- Current treatment with trihexyphenidyl at a daily dose greater than 15 mg
- Current treatment that combines benztropine mesylate with trihexyphenidyl
Show all 10Show fewer
- Current treatment with diphenhydramine
- Current competitive employment or participation (current or within past 3 months) in a program designed to secure competitive employment (e.g., CWT)
- Mini Mental Status Examination (MMSE) score of less than 23
- Diagnosis of current Substance Dependence according to DSM-IV criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Maryland Health Care System, Baltimore
Baltimore, Maryland, 21201
About this study
Official title: Computer Assisted Cognitive Remediation for Schizophrenia
The purpose of this study is to evaluate the efficacy of an innovative, computer driven cognitive rehabilitation program for unemployed veterans with schizophrenia.
Read the detailed description
Schizophrenia leads to a striking array of negative outcomes, including profound deficits in the ability to fulfill desired and expected community roles. Chronic under employment and unemployment are among the most serious of these consequences. VA treats over 100,000 veterans with schizophrenia spectrum disorders, the majority of whom are unable to work competitively and do not participate in VA vocational rehabilitation programs despite the fact that VA is committed to enhancing the ability of these veterans to work. Within VA, a major vehicle for helping veterans to become employed is the Compensated Work Therapy (CWT) program, yet in FY2001 only 800 of the roughly 14000 veterans treated in CWT had SMI diagnoses, and only a subset of those 800 had schizophrenia. A number of factors contribute to low participation in vocational rehabilitation and poor work outcomes, but recent data suggest that one of the most important is cognitive impairment. People with schizophrenia have significant deficits in multiple areas of neurocognition, including secondary and working memory, attention, and executive functioning. These impairments have been shown to play a major role in functional outcome, including the ability to benefit from rehabilitation and to work. As a result, there has been increasing interest in the potential for improving neurocognitive functioning via cognitive rehabilitation. While several programs have yielded promising data, currently there is no empirically validated approach.The purpose of this project is to evaluate the efficacy of an innovative, computer driven cognitive rehabilitation program we have developed: Computer Assisted Cognitive Remediation (CACR). Veterans with schizophrenia who are unemployed and not participating in vocational rehabilitation will be recruited and randomly assigned to one of two conditions: a) 36 sessions of CACR; or b) 36 sessions of a manualized computer control condition (RC). The efficacy of CACR will be assessed on a range of outcome domains, including neuropsychological test, measures of every day and social problem solving, self-reported cognitive functioning and self-efficacy, and work readiness. All subjects will be referred to CWT at the conclusion of treatment and we will assess how many receive work assignments, and work performance (over 3-months) of those who begin work. We hypothesize that CACR will be more effective than the control treatment in each domain.The results of this project could have important implications for treatment of veterans with schizophrenia. CACR is a manualized program that can be administered by BA level staff. If demonstrated to be efficacious, it could be disseminated throughout VA and have a beneficial impact on vocational outcomes and the quality of life of veterans with schizophrenia.
- Conditions
- Schizophrenia
- Being tested
- computer-assisted cognitive remediation (CACR), manualized computer control condition (RC).
- Keywords
- cognition, schizophrenia, treatment
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
computer-assisted cognitive remediation (CACR)Behavioural
Also called CACR
36 individual computer sessions with a staff clinician. computer activities consist of commercially available educational software designed for use in the classroom.
manualized computer control condition (RC).Behavioural
Also called RC
36 sessions of a manualized computer control condition.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | computer-assisted cognitive remediation (CACR) Receives: Behavioral: computer-assisted cognitive remediation (CACR) |
| 2 | Active comparator | computer-based cognitive activity Receives: Behavioral: manualized computer control condition (RC). |
What is being measured
The primary outcome is the main question the study is designed to answer.
cognitive performance and every day problem solving
Measured: post-treatment and 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2005 (estimated)
- Study startNov 2004
- Primary completionJun 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Investigators
- Alan S. Bellack, PhD, Principal investigator, VA Maryland Health Care System, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00261794
- Sponsor's protocol ID
- D3153R
- Status last verified
- Jan 2010
- First submitted
- 1 Dec 2005
- Last updated
- 6 Jan 2010
- Results posted
- No
Publications
Bellack AS, Gold JM, Buchanan RW. Cognitive rehabilitation for schizophrenia: problems, prospects, and strategies. Schizophr Bull. 1999;25(2):257-74. doi: 10.1093/oxfordjournals.schbul.a033377.
PubMed 10416730Bellack AS. Skills training for people with severe mental illness. Psychiatr Rehabil J. 2004 Spring;27(4):375-91. doi: 10.2975/27.2004.375.391.
PubMed 15222149Dickinson D, Tenhula W, Morris S, Brown C, Peer J, Spencer K, Li L, Gold JM, Bellack AS. A randomized, controlled trial of computer-assisted cognitive remediation for schizophrenia. Am J Psychiatry. 2010 Feb;167(2):170-80. doi: 10.1176/appi.ajp.2009.09020264. Epub 2009 Dec 15.
PubMed 20008941
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computer Assisted Cognitive Remediation for Schizophrenia
- ClinicalTrials.gov ID
- NCT00261794
- Acronym / sponsor ID
- D3153R
- Conditions
- Schizophrenia
- Keywords
- cognition, schizophrenia, treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Nov 2004
- Primary completion
- Jun 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 5 Dec 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 evaluate the efficacy of an innovative, computer driven cognitive rehabilitation program for unemployed veterans with schizophrenia.
Detailed description
Schizophrenia leads to a striking array of negative outcomes, including profound deficits in the ability to fulfill desired and expected community roles. Chronic under employment and unemployment are among the most serious of these consequences. VA treats over 100,000 veterans with schizophrenia spectrum disorders, the majority of whom are unable to work competitively and do not participate in VA vocational rehabilitation programs despite the fact that VA is committed to enhancing the ability of these veterans to work. Within VA, a major vehicle for helping veterans to become employed is the Compensated Work Therapy (CWT) program, yet in FY2001 only 800 of the roughly 14000 veterans treated in CWT had SMI diagnoses, and only a subset of those 800 had schizophrenia. A number of factors contribute to low participation in vocational rehabilitation and poor work outcomes, but recent data suggest that one of the most important is cognitive impairment. People with schizophrenia have significant deficits in multiple areas of neurocognition, including secondary and working memory, attention, and executive functioning. These impairments have been shown to play a major role in functional outcome, including the ability to benefit from rehabilitation and to work. As a result, there has been increasing interest in the potential for improving neurocognitive functioning via cognitive rehabilitation. While several programs have yielded promising data, currently there is no empirically validated approach.The purpose of this project is to evaluate the efficacy of an innovative, computer driven cognitive rehabilitation program we have developed: Computer Assisted Cognitive Remediation (CACR). Veterans with schizophrenia who are unemployed and not participating in vocational rehabilitation will be recruited and randomly assigned to one of two conditions: a) 36 sessions of CACR; or b) 36 sessions of a manualized computer control condition (RC). The efficacy of CACR will be assessed on a range of outcome domains, including neuropsychological test, measures of every day and social problem solving, self-reported cognitive functioning and self-efficacy, and work readiness. All subjects will be referred to CWT at the conclusion of treatment and we will assess how many receive work assignments, and work performance (over 3-months) of those who begin work. We hypothesize that CACR will be more effective than the control treatment in each domain.The results of this project could have important implications for treatment of veterans with schizophrenia. CACR is a manualized program that can be administered by BA level staff. If demonstrated to be efficacious, it could be disseminated throughout VA and have a beneficial impact on vocational outcomes and the quality of life of veterans with schizophrenia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: computer-assisted cognitive remediation (CACR)computer-assisted cognitive remediation (CACR) |
| 2 | Active comparator | Behavioral: manualized computer control condition (RC).computer-based cognitive activity |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Current DSM-IV diagnoses of schizophrenia or schizoaffective disorder
- Stable clinical course and antipsychotic treatment on a new generation antipsychotic other than clozapine and/or a dose of first generation antipsychotic equivalent to 10 mg. or less of haloperidol for one month prior to enrollment
- Age between 18 and 64 years
- Voluntary consent after receiving full information about the study
Key exclusion criteria (10 listed)
- Documented history of neurological disorder or significant head trauma with extended loss of consciousness
- Physical limitations (e.g., with hearing or vision) that would interfere substantially with the use of computer-based exercises
- Current treatment with a first generation antipsychotic medication at a dose equivalent to more than 10 mg. of haloperidol
- Current treatment with benztropine mesylate at a daily does greater than 4 mg
- Current treatment with trihexyphenidyl at a daily dose greater than 15 mg
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-assisted cognitive remediation (CACR)Also: CACR36 individual computer sessions with a staff clinician. computer activities consist of commercially available educational software designed for use in the classroom. | Behavioural | 1 |
| manualized computer control condition (RC).Also: RC36 sessions of a manualized computer control condition. | Behavioural | 2 |
Primary outcome
cognitive performance and every day problem solving
Time frame: post-treatment and 3-month follow-up
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 6 Jan 2010.
- Results publication: PubMed 10416730Bellack AS, Gold JM, Buchanan RW. Cognitive rehabilitation for schizophrenia: problems, prospects, and strategies. Schizophr Bull. 1999;25(2):257-74. doi: 10.1093/oxfordjournals.schbul.a033377.
- Results publication: PubMed 15222149Bellack AS. Skills training for people with severe mental illness. Psychiatr Rehabil J. 2004 Spring;27(4):375-91. doi: 10.2975/27.2004.375.391.
- Results publication: PubMed 20008941Dickinson D, Tenhula W, Morris S, Brown C, Peer J, Spencer K, Li L, Gold JM, Bellack AS. A randomized, controlled trial of computer-assisted cognitive remediation for schizophrenia. Am J Psychiatry. 2010 Feb;167(2):170-80. doi: 10.1176/appi.ajp.2009.09020264. Epub 2009 Dec 15.
Related trials for Schizophrenia
RecruitingPhase 3
Safety and Tolerability Trial of Lumateperone in Pediatric Patients With Schizophrenia, Bipolar Disorder or Autism Spectrum Disorder
Schizophrenia, Bipolar Disorder
RecruitingPhase 1
A Study of the Feasibility, Safety and Tolerability of Aticaprant as Adjunctive Treatment in Participants With Schizophrenia
Schizophrenia
Not yet recruiting
NEURO-COGS: Neurometabolic Mechanisms of Cognitive Training in Schizophrenia
Schizophrenia, Schizoaffective Disorder
Not yet recruitingPhase 3
Phase 3 Study of HS-10380 for Acute Schizophrenia in Chinese Adults
SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingObservational study
Real-World Impact of TV-44749 in Adults With Schizophrenia
Schizophrenia
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.
Alan S. Bellack, PhD principal investigator
VA Maryland Health Care System, Baltimore
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-assisted cognitive remediation (CACR) in people with Schizophrenia, run by US Department of Veterans Affairs 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 4 inclusion and 10 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 6 Jan 2010. 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?
cognitive performance and every day problem solving (time frame: post-treatment and 3-month follow-up). 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 NCT00261794, which also lists 3 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 6 Jan 2010; AzTrials last refreshed its copy on 4 Nov 2026.