SchizophreniaEarly Phase 1NCT01175642
Cognitive Remediation and Functional Skills Training in Schizophrenia
A Early Phase 1 study testing Cognitive Remediation and FAST in people with Schizophrenia and Schizoaffective Disorder, run by National Alliance for Research on Schizophrenia and Depression at 1 site in Canada.
Trial summary
This randomized trial is examining whether a treatment called cognitive remediation is more effective when it is paired with a social and functional skills training component. 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 Remediation and FAST
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2007to Sep 2010
- Phase
- Early Phase 1
- 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
- Enrolled in outpatient mental health care
- Reading level of 6th grade or higher
- English speaking
Who cannot join
- Medical conditions known to affect cognition
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Specificity and Generalizability of Cognitive Remediation and Functional Skills Training in Schizophrenia
This randomized trial is examining whether a treatment called cognitive remediation is more effective when it is paired with a social and functional skills training component.
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Being tested
- Cognitive Remediation, FAST
- Keywords
- Schizophrenia, Psychosis, Schizoaffective Disorder
- 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 RemediationBehavioural
Computer-based, therapist-lead cognitive remediation
FASTBehavioural
Functional adaptive skills training. Group treatment to foster the acquisition of social and adaptive skills
| Study group | Role | What they receive |
|---|---|---|
| Cognitive remediation | Experimental | Cognitive remediation Receives: Behavioral: Cognitive Remediation |
| Functional Adaptive Skills Training | Active comparator | Functional and social skills group treatment Receives: Behavioral: FAST |
| Combined Treatment | Active comparator | Combined cognitive remediation and functional adaptive skills training Receives: Behavioral: Cognitive Remediation; Behavioral: FAST |
What is being measured
The primary outcome is the main question the study is designed to answer.
neurocognition
Measured: 12 weeks
Secondary outcomes (5)
functional competence
performance-based measures of functional and social competence
Measured: 12 weeks
neurocognition
Measured: 24 weeks
neurocognition
Measured: 36 weeks
functional competence
Measured: 24 weeks
functional competence
Measured: 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2010 (estimated)
- Study startJul 2007
- Primary completionAug 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Alliance for Research on Schizophrenia and Depression
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher R. Bowie, National Alliance for Research on Schizophrenia and Depression
- Investigators
- Christopher R Bowie, PhD, Principal investigator, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01175642
- Sponsor's protocol ID
- PSYC-085-08
- Status last verified
- Aug 2010
- First submitted
- 3 Aug 2010
- Last updated
- 17 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Bowie CR, McGurk SR, Mausbach B, Patterson TL, Harvey PD. Combined cognitive remediation and functional skills training for schizophrenia: effects on cognition, functional competence, and real-world behavior. Am J Psychiatry. 2012 Jul;169(7):710-8. doi: 10.1176/appi.ajp.2012.11091337.
PubMed 22581070
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Specificity and Generalizability of Cognitive Remediation and Functional Skills Training in Schizophrenia
- ClinicalTrials.gov ID
- NCT01175642
- Acronym / sponsor ID
- PSYC-085-08
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Keywords
- Schizophrenia, Psychosis, Schizoaffective Disorder
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- National Alliance for Research on Schizophrenia and DepressionUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Aug 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 5 Aug 2010 (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 randomized trial is examining whether a treatment called cognitive remediation is more effective when it is paired with a social and functional skills training component.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cognitive remediation | Experimental | Behavioral: Cognitive RemediationCognitive remediation |
| Functional Adaptive Skills Training | Active comparator | Behavioral: FASTFunctional and social skills group treatment |
| Combined Treatment | Active comparator | Behavioral: Cognitive Remediation, Behavioral: FASTCombined cognitive remediation and functional adaptive skills training |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of schizophrenia or schizoaffective disorder
- Enrolled in outpatient mental health care
- Reading level of 6th grade or higher
- English speaking
Key exclusion criteria (1 listed)
- Medical conditions known to affect cognition
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 RemediationComputer-based, therapist-lead cognitive remediation | Behavioural | Cognitive remediation, Combined Treatment |
| FASTFunctional adaptive skills training. Group treatment to foster the acquisition of social and adaptive skills | Behavioural | Combined Treatment, Functional Adaptive Skills Training |
Primary outcome
neurocognition
Time frame: 12 weeks
5 secondary outcomes
functional competence
Time frame: 12 weeks
neurocognition
Time frame: 24 weeks
neurocognition
Time frame: 36 weeks
functional competence
Time frame: 24 weeks
functional competence
Time frame: 36 weeks
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 17 Nov 2016.
- Derived from this study: PubMed 22581070Bowie CR, McGurk SR, Mausbach B, Patterson TL, Harvey PD. Combined cognitive remediation and functional skills training for schizophrenia: effects on cognition, functional competence, and real-world behavior. Am J Psychiatry. 2012 Jul;169(7):710-8. doi: 10.1176/appi.ajp.2012.11091337.
- Individual participant dataSharing planned: No
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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.
Christopher R Bowie, PhD principal investigator
Queen's University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Cognitive Remediation and FAST in people with Schizophrenia and Schizoaffective Disorder, run by National Alliance for Research on Schizophrenia and Depression at 1 site in Canada.
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 1 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 17 Nov 2016. 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 Canada. 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 phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
neurocognition (time frame: 12 weeks). 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 NCT01175642, which also lists 1 linked publication.
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 17 Nov 2016; AzTrials last refreshed its copy on 6 Nov 2026.