Schizophrenia and Related DisordersTSWNCT03483701
Thinking Skills at Work: Cognitive Remediation Therapy for Patients With Serious Mental Illness
A study testing Cognitive Remediation Therapy in people with Schizophrenia and Related Disorders and Psychotic Disorder, run by Fraser Health at 1 site in Canada.
Trial summary
The purpose of this study is to help people with serious mental illness get and keep the job they want by improving their thinking skills, using cognitive remediation therapy. For people with serious mental illness, the Individual Placement and Support (IPS) Program is an effective approach to help people become… Read more about this study
- Who is it for?
- Ages 19 to 60 years
- Conditions the study is for
- Schizophrenia and Related Disorders, Psychotic Disorder
- What is being tested?
- Cognitive Remediation Therapy
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteCanada
- Study dates
- 1 Apr 2017to 25 May 2020
- 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 19 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Participants aged 19-60 years old
- Enrolled in the IPS program for at least 3 months
- Clinically stable (no changes to psychiatric medication and psychiatric hospitalization in the 30 days prior to intake)
Who cannot join
- History of traumatic brain injury
- Neurological disorder
- Developmental disability
- Difficulty understanding written and spoken English
Trial locations and contacts
1 site in 1 country.
Canada1 site
Fraser Health: Royal Columbian Hospital
New Westminster, British Columbia, V3L 3W7
About this study
Official title: Cognitive Remediation Therapy for Patients With Serious Mental Illness Who Failed to Benefit From Supported Employment
The purpose of this study is to help people with serious mental illness get and keep the job they want by improving their thinking skills, using cognitive remediation therapy. For people with serious mental illness, the Individual Placement and Support (IPS) Program is an effective approach to help people become employed. Despite its general success, still only 55% of clients find employment. Most of that success occurs in the first three months; after six months, the chances of finding competitive work are quite low. Among those who fail to find employment with IPS, cognitive dysfunction is often a significant problem. The proposed study will target IPS clients who have not found work after 3 months of employment-support services: our hypothesis is that, after three months with no success, the addition of cognitive remediation to IPS will improve employment rates (compared to those who continue to receive IPS alone).
The proposed randomized controlled trial will use a single-blind study design, focused on IPS clients who are slow to (or may never) find employment success. Specifically, the proposed study will have two treatment arms: a) cognitive remediation added to continued IPS services, and b) continued IPS services alone. The study will collaborate with IPS workers at 11 Mental Health and Substance Use (MHSU) clinics to identify clients who are non-responders in the first 3 months, and seek their consent to participate in the study. They will be randomized to either TAU (continuation with IPS and other standard treatments), or TAU plus cognitive remediation. The CRT will consist of computerized cognitive exercise practice, strategy coaching, and teaching coping/compensatory strategies for 12 weeks. Clients will be assessed at 3-time points: prior to the start of cognitive remediation ("baseline"), end-point (3-month), and 6 months after the endpoint evaluation. Primary outcome measures will include success at gaining a competitive job, total hours of competitive employment, and neuropsychological measures of cognition.
Read the detailed description
Background Information:
The Individual Placement and Support (IPS) program is an evidence-based vocational rehabilitation services that assist individuals with mental illness or significant mental health concerns gain and maintain competitive employment in the community. Unemployment rates among people with mental illness are high, even though most people with serious mental illness want to work.
Fraser Health provides IPS services to approximately 350 MHSU clients per year in six communities. The IPS strategy helps about 55% of clients find competitive jobs, but almost half (45%) fail to find work. Among those who fail to find employment, cognitive dysfunction is often a significant problem.
Cognitive remediation therapy (CRT) is an evidence-based, psychological treatment for the neurocognitive deficits seen in patients with severe mental illness. CRT targets cognitive functioning with the goal of improving role functioning in daily life. When compared with employment intervention alone, programs that incorporate CRT have shown a variety of vocational benefits, (e.g., more likely to work, held more jobs, worked more weeks, and earned more in wages) that are maintained even at a 3-year follow-up. CRT targeted to clients who have not been successful with IPS is efficient: non-responders improved employment outcome with a number needed-to-treat (NNT) of 4 over a two-year period.
Cognitive remediation (CRT) improves thinking skills and work functioning. CRT provides specific training modules and exercises that target thinking skills known to be impaired in severe mental illness. For example, working memory and cognitive flexibility are trained through real-world exercises that teach clients to organize and manage time, focus their attention, consider errors and their consequences, control answers and plan ahead. These skills are important to be successful in obtaining and maintaining employment.
Purpose of Study:
The primary purpose of this study is to assess, for people with serious mental illness who have failed to find employment despite three months of support in the IPS program, the effects of 12 weeks of cognitive remediation therapy (CRT) on subsequent employment outcomes while they continue to receive IPS employment-support services. Hypothesis:
The first hypothesis is that adding CRT for those who have not found employment by 3 months in the program will result in better competitive work outcomes, compared to those who continue IPS alone. The second hypothesis is that participants receiving CRT will improve more in cognitive functioning than those who did not receive CRT training. The third hypothesis is that symptom severity will be related to work outcomes.
- Being tested
- Cognitive Remediation Therapy
- Keywords
- Cognitive Remediation Therapy
- 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 Remediation TherapyBehavioural
The intervention of interest for participants in the experimental group is the addition of up to 5 hours per week of computerized cognitive exercises. Cognitive training can be done at home on a computer. For participants without access to a computer, a laptop/tablet computer with the necessary software will be provided for the duration of training. Participants will be able to complete the cognitive exercises on their own schedule, with participation verified by the software. Participants will also receive 1 hour/week of individual coaching to discuss cognitive remediation progress, e.g. to learn about different cognitive domains and develop ways to generalize their cognitive remediation gains.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Remediation Therapy | Experimental | Participants in the experimental group will continue to receive IPS services, which is part of their standard care. In addition, they will be required to complete up to 5 hours per week of computerized cognitive exercises. Cognitive training can be done at home on a computer, on their own schedule. Participants will also receive 1 hour/week of individual coaching to discuss cognitive remediation progress, learn about different cognitive domains and develop ways to generalize their cognitive remediation gains. Receives: Behavioral: Cognitive Remediation Therapy |
| Treatment as Usual | No intervention | Participants in the control condition will continue to receive IPS services as usual. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Employment Outcomes
The number of hours client worked in the past 90 days.
Measured: 90 days
Secondary outcomes (2)
Cognitive Functioning
Cognitive functioning will be measured using the Matrics Consensus Cognitive Battery. The MCCB has 10 tests that measures 7 cognitive domains: speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. Raw scores will be converted to T-score for each domain. T-score has a mean of 50 and a standard deviation of 10.
Measured: 90 minutes
Psychiatric Symptoms
Brief Psychiatric Rating Scale. The BPRS is a semi-structured interview of psychiatric symptoms over the past 2 weeks. There are 24 items rated from 1 to 7 with higher scores indicating more severe symptoms.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2018
- Study start1 Apr 2017
- Primary completion31 Mar 2020
- Study completion25 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Schizophrenia and Related DisordersStudies 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
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fraser Health
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Social Development and Poverty Reduction, British Columbia
- Responsible party
- Sponsor
- Investigators
- David Erickson, PhD, Principal investigator, Fraser Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03483701
- Sponsor's protocol ID
- FHREB No. 2016-096
- Acronym
- TSW
- Status last verified
- Jul 2020
- First submitted
- 16 Mar 2018
- Last updated
- 23 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Marshall T, Goldberg RW, Braude L, Dougherty RH, Daniels AS, Ghose SS, George P, Delphin-Rittmon ME. Supported employment: assessing the evidence. Psychiatr Serv. 2014 Jan 1;65(1):16-23. doi: 10.1176/appi.ps.201300262.
PubMed 24247197Green MF, Kern RS, Heaton RK. Longitudinal studies of cognition and functional outcome in schizophrenia: implications for MATRICS. Schizophr Res. 2004 Dec 15;72(1):41-51. doi: 10.1016/j.schres.2004.09.009.
PubMed 15531406McGurk SR, Mueser KT. Cognitive functioning, symptoms, and work in supported employment: a review and heuristic model. Schizophr Res. 2004 Oct 1;70(2-3):147-73. doi: 10.1016/j.schres.2004.01.009.
PubMed 15329293McGurk SR, Mueser KT, Feldman K, Wolfe R, Pascaris A. Cognitive training for supported employment: 2-3 year outcomes of a randomized controlled trial. Am J Psychiatry. 2007 Mar;164(3):437-41. doi: 10.1176/ajp.2007.164.3.437.
PubMed 17329468McGurk SR, Mueser KT, Xie H, Welsh J, Kaiser S, Drake RE, Becker DR, Bailey E, Fraser G, Wolfe R, McHugo GJ. Cognitive Enhancement Treatment for People With Mental Illness Who Do Not Respond to Supported Employment: A Randomized Controlled Trial. Am J Psychiatry. 2015 Sep 1;172(9):852-61. doi: 10.1176/appi.ajp.2015.14030374. Epub 2015 May 22.
PubMed 25998278Bell MD, Zito W, Greig T, Wexler BE. Neurocognitive enhancement therapy with vocational services: work outcomes at two-year follow-up. Schizophr Res. 2008 Oct;105(1-3):18-29. doi: 10.1016/j.schres.2008.06.026. Epub 2008 Aug 19.
PubMed 18715755Kurtz MM, Wexler BE, Fujimoto M, Shagan DS, Seltzer JC. Symptoms versus neurocognition as predictors of change in life skills in schizophrenia after outpatient rehabilitation. Schizophr Res. 2008 Jul;102(1-3):303-11. doi: 10.1016/j.schres.2008.03.023. Epub 2008 May 20.
PubMed 18495433
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Remediation Therapy for Patients With Serious Mental Illness Who Failed to Benefit From Supported Employment
- ClinicalTrials.gov ID
- NCT03483701
- Acronym / sponsor ID
- TSW / FHREB No. 2016-096
- Keywords
- Cognitive Remediation Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Fraser HealthUniversity, hospital or other
- Collaborators
- Ministry of Social Development and Poverty Reduction, British Columbia
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 25 May 2020 (actual)
- First posted
- 30 Mar 2018 (actual)
- 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 help people with serious mental illness get and keep the job they want by improving their thinking skills, using cognitive remediation therapy. For people with serious mental illness, the Individual Placement and Support (IPS) Program is an effective approach to help people become employed. Despite its general success, still only 55% of clients find employment. Most of that success occurs in the first three months; after six months, the chances of finding competitive work are quite low. Among those who fail to find employment with IPS, cognitive dysfunction is often a significant problem. The proposed study will target IPS clients who have not found work after 3 months of employment-support services: our hypothesis is that, after three months with no success, the addition of cognitive remediation to IPS will improve employment rates (compared to those who continue to receive IPS alone).
The proposed randomized controlled trial will use a single-blind study design, focused on IPS clients who are slow to (or may never) find employment success. Specifically, the proposed study will have two treatment arms: a) cognitive remediation added to continued IPS services, and b) continued IPS services alone. The study will collaborate with IPS workers at 11 Mental Health and Substance Use (MHSU) clinics to identify clients who are non-responders in the first 3 months, and seek their consent to participate in the study. They will be randomized to either TAU (continuation with IPS and other standard treatments), or TAU plus cognitive remediation. The CRT will consist of computerized cognitive exercise practice, strategy coaching, and teaching coping/compensatory strategies for 12 weeks. Clients will be assessed at 3-time points: prior to the start of cognitive remediation ("baseline"), end-point (3-month), and 6 months after the endpoint evaluation. Primary outcome measures will include success at gaining a competitive job, total hours of competitive employment, and neuropsychological measures of cognition.
Detailed description
Background Information:
The Individual Placement and Support (IPS) program is an evidence-based vocational rehabilitation services that assist individuals with mental illness or significant mental health concerns gain and maintain competitive employment in the community. Unemployment rates among people with mental illness are high, even though most people with serious mental illness want to work.
Fraser Health provides IPS services to approximately 350 MHSU clients per year in six communities. The IPS strategy helps about 55% of clients find competitive jobs, but almost half (45%) fail to find work. Among those who fail to find employment, cognitive dysfunction is often a significant problem.
Cognitive remediation therapy (CRT) is an evidence-based, psychological treatment for the neurocognitive deficits seen in patients with severe mental illness. CRT targets cognitive functioning with the goal of improving role functioning in daily life. When compared with employment intervention alone, programs that incorporate CRT have shown a variety of vocational benefits, (e.g., more likely to work, held more jobs, worked more weeks, and earned more in wages) that are maintained even at a 3-year follow-up. CRT targeted to clients who have not been successful with IPS is efficient: non-responders improved employment outcome with a number needed-to-treat (NNT) of 4 over a two-year period.
Cognitive remediation (CRT) improves thinking skills and work functioning. CRT provides specific training modules and exercises that target thinking skills known to be impaired in severe mental illness. For example, working memory and cognitive flexibility are trained through real-world exercises that teach clients to organize and manage time, focus their attention, consider errors and their consequences, control answers and plan ahead. These skills are important to be successful in obtaining and maintaining employment.
Purpose of Study:
The primary purpose of this study is to assess, for people with serious mental illness who have failed to find employment despite three months of support in the IPS program, the effects of 12 weeks of cognitive remediation therapy (CRT) on subsequent employment outcomes while they continue to receive IPS employment-support services. Hypothesis:
The first hypothesis is that adding CRT for those who have not found employment by 3 months in the program will result in better competitive work outcomes, compared to those who continue IPS alone. The second hypothesis is that participants receiving CRT will improve more in cognitive functioning than those who did not receive CRT training. The third hypothesis is that symptom severity will be related to work outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Remediation Therapy | Experimental | Behavioral: Cognitive Remediation TherapyParticipants in the experimental group will continue to receive IPS services, which is part of their standard care. In addition, they will be required to complete up to 5 hours per week of computerized cognitive exercises. Cognitive training can be done at home on a computer, on their own schedule. Participants will also receive 1 hour/week of individual coaching to discuss cognitive remediation progress, learn about different cognitive domains and develop ways to generalize their cognitive remediation gains. |
| Treatment as Usual | No intervention | –Participants in the control condition will continue to receive IPS services as usual. |
Who may qualify
- Ages
- 19 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Participants aged 19-60 years old
- Enrolled in the IPS program for at least 3 months
- Clinically stable (no changes to psychiatric medication and psychiatric hospitalization in the 30 days prior to intake)
Key exclusion criteria (4 listed)
- History of traumatic brain injury
- Neurological disorder
- Developmental disability
- Difficulty understanding written and spoken English
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 Remediation TherapyThe intervention of interest for participants in the experimental group is the addition of up to 5 hours per week of computerized cognitive exercises. Cognitive training can be done at home on a computer. For participants without access to a computer, a laptop/tablet computer with the necessary software will be provided for the duration of training. Participants will be able to complete the cognitive exercises on their own schedule, with participation verified by the software. Participants will also receive 1 hour/week of individual coaching to discuss cognitive remediation progress, e.g. to learn about different cognitive domains and develop ways to generalize their cognitive remediation gains. | Behavioural | Cognitive Remediation Therapy |
Primary outcome
Employment Outcomes
Time frame: 90 days
The number of hours client worked in the past 90 days.
2 secondary outcomes
Cognitive Functioning
Time frame: 90 minutes
Psychiatric Symptoms
Time frame: 2 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 23 Jul 2020.
- Background: PubMed 24247197Marshall T, Goldberg RW, Braude L, Dougherty RH, Daniels AS, Ghose SS, George P, Delphin-Rittmon ME. Supported employment: assessing the evidence. Psychiatr Serv. 2014 Jan 1;65(1):16-23. doi: 10.1176/appi.ps.201300262.
- Background: PubMed 15531406Green MF, Kern RS, Heaton RK. Longitudinal studies of cognition and functional outcome in schizophrenia: implications for MATRICS. Schizophr Res. 2004 Dec 15;72(1):41-51. doi: 10.1016/j.schres.2004.09.009.
- Background: PubMed 15329293McGurk SR, Mueser KT. Cognitive functioning, symptoms, and work in supported employment: a review and heuristic model. Schizophr Res. 2004 Oct 1;70(2-3):147-73. doi: 10.1016/j.schres.2004.01.009.
- Background: PubMed 17329468McGurk SR, Mueser KT, Feldman K, Wolfe R, Pascaris A. Cognitive training for supported employment: 2-3 year outcomes of a randomized controlled trial. Am J Psychiatry. 2007 Mar;164(3):437-41. doi: 10.1176/ajp.2007.164.3.437.
- Background: PubMed 25998278McGurk SR, Mueser KT, Xie H, Welsh J, Kaiser S, Drake RE, Becker DR, Bailey E, Fraser G, Wolfe R, McHugo GJ. Cognitive Enhancement Treatment for People With Mental Illness Who Do Not Respond to Supported Employment: A Randomized Controlled Trial. Am J Psychiatry. 2015 Sep 1;172(9):852-61. doi: 10.1176/appi.ajp.2015.14030374. Epub 2015 May 22.
- Background: PubMed 18715755Bell MD, Zito W, Greig T, Wexler BE. Neurocognitive enhancement therapy with vocational services: work outcomes at two-year follow-up. Schizophr Res. 2008 Oct;105(1-3):18-29. doi: 10.1016/j.schres.2008.06.026. Epub 2008 Aug 19.
- Background: PubMed 18495433Kurtz MM, Wexler BE, Fujimoto M, Shagan DS, Seltzer JC. Symptoms versus neurocognition as predictors of change in life skills in schizophrenia after outpatient rehabilitation. Schizophr Res. 2008 Jul;102(1-3):303-11. doi: 10.1016/j.schres.2008.03.023. Epub 2008 May 20.
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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.
David Erickson, PhD principal investigator
Fraser Health
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 Remediation Therapy in people with Schizophrenia and Related Disorders and Psychotic Disorder, run by Fraser Health 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 3 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 23 Jul 2020. 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.
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?
Employment Outcomes (time frame: 90 days). 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 NCT03483701, which also lists 7 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 23 Jul 2020.