SchizophreniaPhase 2NCT00895258
Cognitive Training to Improve Work Outcomes in Severe Mental Illness
A Phase 2 study testing Individual placement and support plus cognitive training (IPS-CT) and Individual placement and support plus enhanced support (IPS-ES) in people with Schizophrenia and Bipolar Disorder, run by University of California, San Diego at 1 site in United States.
Trial summary
This study will compare the efficacy of two types of supportive treatments for a program called Individual Placement and Support, which helps people with severe mental illnesses find and keep jobs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia, Bipolar Disorder, Depression
- What is being tested?
- Individual placement and support plus cognitive training (IPS-CT) and Individual placement and support plus enhanced support (IPS-ES)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 163 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Mar 2014
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Receiving psychiatric care at UCSD Outpatient Psychiatric Services
- DSM-IV diagnosis of a severe mental illness, including schizophrenia, schizoaffective disorder, bipolar disorder, or major depressive disorder
- Unemployed in the past 30 days, but stating a goal of work
- Fluency and literacy in English
Who cannot join
- Presence of dementia
- Presence of mental retardation
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSD Outpatient Psychiatric Services
San Diego, California, 92103
About this study
This study will compare the efficacy of two types of supportive treatments for a program called Individual Placement and Support, which helps people with severe mental illnesses find and keep jobs.
Read the detailed description
Unemployment in people with severe mental illnesses (SMIs), such as schizophrenia, bipolar disorder, and major depressive disorder, has both economic and health-related costs. Unemployed people with SMIs often report an improved quality of life after finding a job, through increases in self-esteem, socialization, opportunities to use skills and abilities, external structure, and income. Supported employment plans, such as Individualized Placement and Support (IPS), help to place and support people with SMIs in jobs available in their community. However, people with SMIs often have difficulties keeping jobs. Research suggests these difficulties are due to cognitive deficits-underlying patterns of thought. This study will test two versions of IPS to see which produces the best outcomes for people with SMIs looking for jobs: one version will be supplemented with cognitive training (CT), which will address cognitive deficits related to work, and the other version will be supplemented with enhanced support (ES), which will increase the support people with SMIs receive with their jobs.
Participation in this study will last 24 months. Participants will first undergo a baseline assessment and then will be randomly assigned to receive IPS with CT or IPS with ES. Participants in both groups will complete one IPS session and one support session-either CT or ES-each week for 12 weeks. The IPS sessions will involve working with a vocational counselor to find a job and then receiving support in training for and maintaining that job. Participants receiving CT sessions will be taught strategies to improve attention, learning and memory, and problem-solving. Participants receiving ES will receive extra sessions of vocational support. All participants will complete assessments at six times: at study entry and after 3, 6, 12, 18, and 24 months. These assessments will include interviews about life circumstances, psychiatric symptoms, and job satisfaction. The first four assessment sessions will involve additional tests-administered with a pencil and paper or on a computer-that measure thinking, learning, memory, and problem-solving abilities.
- Conditions
- Schizophrenia, Bipolar Disorder, Depression
- Being tested
- Individual placement and support plus cognitive training (IPS-CT), Individual placement and support plus enhanced support (IPS-ES)
- Keywords
- Schizoaffective Disorder, Major Depressive Disorder, Supported Employment, Work, Rehabilitation, Severe Mental Illness, Cognitive Training, Cognitive Rehabilitation, Cognitive Remediation
- Medical subject headings
- Schizophrenia, Bipolar Disorder, Depression, Psychotic Disorders, Depressive Disorder, Major, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individual placement and support plus cognitive training (IPS-CT)Behavioural
One IPS plus one CT session each week for 12 weeks
Individual placement and support plus enhanced support (IPS-ES)Behavioural
One IPS plus one ES session each week for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| IPS-CT | Experimental | Participants will receive individual placement and support (IPS) plus cognitive training (CT). Receives: Behavioral: Individual placement and support plus cognitive training (IPS-CT) |
| IPS-ES | Active comparator | Participants will receive individual placement and support (IPS) plus enhanced support (ES). Receives: Behavioral: Individual placement and support plus enhanced support (IPS-ES) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weeks worked
Measured: Measured weekly for 2 years
Secondary outcomes (2)
Cognition, based on the extended Measurement And Treatment Research to Improve Cognition in Schizophrenia (MATRICS) battery
Measured: Measured at baseline and after 3, 6, 12, 18, and 24 months
Functioning
Measured: Measured at baseline and after 3, 6, 12, 18, and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2009 (estimated)
- Study startApr 2008
- Primary completionMar 2014
- Study completionMar 2014
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.
- More trials run by University of California, San DiegoThe 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, ETwamley, University of California, San Diego
- Investigators
- Elizabeth W. Twamley, PhD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00895258
- Sponsor's protocol ID
- R01MH080150
- Other IDs
- R01MH080150, DSIR 82-SEDX
- Status last verified
- Jun 2014
- First submitted
- 7 May 2009
- Last updated
- 19 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Burton CZ, Vella L, Twamley EW. Prospective memory, level of disability, and return to work in severe mental illness. Clin Neuropsychol. 2019 Apr;33(3):594-605. doi: 10.1080/13854046.2018.1436725. Epub 2018 Feb 25.
PubMed 29480043
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Training to Improve Work Outcomes in Severe Mental Illness
- ClinicalTrials.gov ID
- NCT00895258
- Acronym / sponsor ID
- R01MH080150
- Conditions
- Schizophrenia, Bipolar Disorder, Depression
- Keywords
- Schizoaffective Disorder, Major Depressive Disorder, Supported Employment, Work, Rehabilitation, Severe Mental Illness, Cognitive Training, Cognitive Rehabilitation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Apr 2008
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 8 May 2009 (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 compare the efficacy of two types of supportive treatments for a program called Individual Placement and Support, which helps people with severe mental illnesses find and keep jobs.
Detailed description
Unemployment in people with severe mental illnesses (SMIs), such as schizophrenia, bipolar disorder, and major depressive disorder, has both economic and health-related costs. Unemployed people with SMIs often report an improved quality of life after finding a job, through increases in self-esteem, socialization, opportunities to use skills and abilities, external structure, and income. Supported employment plans, such as Individualized Placement and Support (IPS), help to place and support people with SMIs in jobs available in their community. However, people with SMIs often have difficulties keeping jobs. Research suggests these difficulties are due to cognitive deficits-underlying patterns of thought. This study will test two versions of IPS to see which produces the best outcomes for people with SMIs looking for jobs: one version will be supplemented with cognitive training (CT), which will address cognitive deficits related to work, and the other version will be supplemented with enhanced support (ES), which will increase the support people with SMIs receive with their jobs.
Participation in this study will last 24 months. Participants will first undergo a baseline assessment and then will be randomly assigned to receive IPS with CT or IPS with ES. Participants in both groups will complete one IPS session and one support session-either CT or ES-each week for 12 weeks. The IPS sessions will involve working with a vocational counselor to find a job and then receiving support in training for and maintaining that job. Participants receiving CT sessions will be taught strategies to improve attention, learning and memory, and problem-solving. Participants receiving ES will receive extra sessions of vocational support. All participants will complete assessments at six times: at study entry and after 3, 6, 12, 18, and 24 months. These assessments will include interviews about life circumstances, psychiatric symptoms, and job satisfaction. The first four assessment sessions will involve additional tests-administered with a pencil and paper or on a computer-that measure thinking, learning, memory, and problem-solving abilities.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IPS-CT | Experimental | Behavioral: Individual placement and support plus cognitive training (IPS-CT)Participants will receive individual placement and support (IPS) plus cognitive training (CT). |
| IPS-ES | Active comparator | Behavioral: Individual placement and support plus enhanced support (IPS-ES)Participants will receive individual placement and support (IPS) plus enhanced support (ES). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Receiving psychiatric care at UCSD Outpatient Psychiatric Services
- DSM-IV diagnosis of a severe mental illness, including schizophrenia, schizoaffective disorder, bipolar disorder, or major depressive disorder
- Unemployed in the past 30 days, but stating a goal of work
- Fluency and literacy in English
Key exclusion criteria (2 listed)
- Presence of dementia
- Presence of mental retardation
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 |
|---|---|---|
| Individual placement and support plus cognitive training (IPS-CT)One IPS plus one CT session each week for 12 weeks | Behavioural | IPS-CT |
| Individual placement and support plus enhanced support (IPS-ES)One IPS plus one ES session each week for 12 weeks | Behavioural | IPS-ES |
Primary outcome
Weeks worked
Time frame: Measured weekly for 2 years
2 secondary outcomes
Cognition, based on the extended Measurement And Treatment Research to Improve Cognition in Schizophrenia (MATRICS) battery
Time frame: Measured at baseline and after 3, 6, 12, 18, and 24 months
Functioning
Time frame: Measured at baseline and after 3, 6, 12, 18, and 24 months
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 19 Jun 2014.
- Derived from this study: PubMed 29480043Burton CZ, Vella L, Twamley EW. Prospective memory, level of disability, and return to work in severe mental illness. Clin Neuropsychol. 2019 Apr;33(3):594-605. doi: 10.1080/13854046.2018.1436725. Epub 2018 Feb 25.
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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
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Individual placement and support plus cognitive training (IPS-CT) and Individual placement and support plus enhanced support (IPS-ES) in people with Schizophrenia and Bipolar 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 4 inclusion and 2 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 19 Jun 2014. 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 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.
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?
Weeks worked (time frame: Measured weekly for 2 years). 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 NCT00895258, 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 19 Jun 2014.