SchizophreniaNCT01521026
Cognitive Training for Patients With Schizophrenia
A study testing Cognitive Training in people with Schizophrenia and Schizoaffective Disorder, run by University of California, San Diego at 1 site in United States.
Trial summary
This research on cognitive training addresses the following questions: 1. Does cognitive training lead to improved cognition, functional abilities, psychiatric symptoms, treatment adherence, or quality of life in patients with psychoses? 2. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder, Other Primary Psychotic Disorders
- What is being tested?
- Cognitive Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2003to Aug 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Primary psychotic disorder (including schizophrenia, schizoaffective disorder, psychotic mood disorder, or psychosis NOS)
- Age 18 or older
- Fluency in English
Who cannot join
- Dementia
- Neurological conditions affecting cognition
- Mental retardation
- Substance use disorder within the past month
- Participation in other intervention trials
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSD Outpatient Psychiatric Services
San Diego, California, 92103
About this study
This research on cognitive training addresses the following questions:
- Does cognitive training lead to improved cognition, functional abilities, psychiatric symptoms, treatment adherence, or quality of life in patients with psychoses?
- What are the neurocognitive and non-cognitive factors that predict good outcomes following cognitive rehabilitation? In addition to verbal learning and memory, immediate verbal memory, vigilance, and executive functioning, the cognitive training intervention attempted to improve prospective memory ability (i.e., the ability to remember to do things in the future, such as take medications or attend a doctor's appointment).
- Being tested
- Cognitive Training
- 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 TrainingBehavioural
12-week compensatory cognitive training in group format
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Training | Experimental | Cognitive training group Receives: Behavioral: Cognitive Training |
| Standard Pharmacotherapy | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
UCSD Performance-based Skills Assessment Total Score (Measures Functional Capacity)
Performance-based measure of functional capacity in five domains: Communication, Finance, Recreation Planning, Transportation, and Household Chores Scale ranges from 0-100. Subscales are summed to yield the total score. Higher scores represent better performance.
Measured: 3 months
Secondary outcomes (1)
Hopkins Verbal Learning Test Percent Retained
Verbal list learning task with three learning trials and a delay trial. Percent retained refers to the percentage of items recalled at the delay trial, compared to the third learning trial.
Score ranges from 0-100. Higher scores represent better performance.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2012 (estimated)
- Study startSep 2003
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- National Alliance for Research on Schizophrenia and Depression
- Responsible party
- Principal investigator, Elizabeth Twamley, University of California, San Diego
- Investigators
- Elizabeth W Twamley, PhD, Principal investigator, UCSD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01521026
- Sponsor's protocol ID
- NARSAD Young Investigator
- Status last verified
- Jun 2023
- First submitted
- 22 Jan 2012
- Last updated
- 5 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Twamley EW, Vella L, Burton CZ, Heaton RK, Jeste DV. Compensatory cognitive training for psychosis: effects in a randomized controlled trial. J Clin Psychiatry. 2012 Sep;73(9):1212-9. doi: 10.4088/JCP.12m07686. Epub 2012 Aug 7.
PubMed 22939029
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Training for Patients With Schizophrenia
- ClinicalTrials.gov ID
- NCT01521026
- Acronym / sponsor ID
- NARSAD Young Investigator
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- National Alliance for Research on Schizophrenia and Depression
- Study start
- Sep 2003
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 30 Jan 2012 (estimated)
- Results
- Posted 11 Dec 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research on cognitive training addresses the following questions:
- Does cognitive training lead to improved cognition, functional abilities, psychiatric symptoms, treatment adherence, or quality of life in patients with psychoses?
- What are the neurocognitive and non-cognitive factors that predict good outcomes following cognitive rehabilitation? In addition to verbal learning and memory, immediate verbal memory, vigilance, and executive functioning, the cognitive training intervention attempted to improve prospective memory ability (i.e., the ability to remember to do things in the future, such as take medications or attend a doctor's appointment).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Training | Experimental | Behavioral: Cognitive TrainingCognitive training group |
| Standard Pharmacotherapy | No intervention | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Primary psychotic disorder (including schizophrenia, schizoaffective disorder, psychotic mood disorder, or psychosis NOS)
- Age 18 or older
- Fluency in English
Key exclusion criteria (5 listed)
- Dementia
- Neurological conditions affecting cognition
- Mental retardation
- Substance use disorder within the past month
- Participation in other intervention trials
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 Training12-week compensatory cognitive training in group format | Behavioural | Cognitive Training |
Primary outcome
UCSD Performance-based Skills Assessment Total Score (Measures Functional Capacity)
Time frame: 3 months
Performance-based measure of functional capacity in five domains: Communication, Finance, Recreation Planning, Transportation, and Household Chores Scale ranges from 0-100. Subscales are summed to yield the total score. Higher scores represent better performance.
1 secondary outcome
Hopkins Verbal Learning Test Percent Retained
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22939029Twamley EW, Vella L, Burton CZ, Heaton RK, Jeste DV. Compensatory cognitive training for psychosis: effects in a randomized controlled trial. J Clin Psychiatry. 2012 Sep;73(9):1212-9. doi: 10.4088/JCP.12m07686. Epub 2012 Aug 7.
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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.
Elizabeth W Twamley, PhD principal investigator
UCSD
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 Training in people with Schizophrenia and Schizoaffective Disorder, run by University of California, San Diego 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 3 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 5 Jul 2023. 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?
Yes. Results are posted in the registry (first posted 11 Dec 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
UCSD Performance-based Skills Assessment Total Score (Measures Functional Capacity) (time frame: 3 months). 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 NCT01521026, 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 5 Jul 2023.