SchizophreniaTSWNCT01926613
Thinking Skills for Work in Severe Mental Illness
A study testing Thinking Skills for Work Program and Supported Employment in people with Schizophrenia and Schizoaffective Disorder, run by Dartmouth-Hitchcock Medical Center at 2 sites in United States.
Trial summary
The purpose of this study is help people with serious mental illness and receiving vocational rehabilitation get and keep the job they want by improving their thinking skills, such as attention and memory, using computer exercises and other strategies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder, Major Depression
- What is being tested?
- Thinking Skills for Work Program and Supported Employment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2006to Oct 2011
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic mental disorder
- Minimum age 18
- Unemployed
- Wants employment
- Must be a recipient of services at one of two participating agencies
- Fluent in English
- Willing and legally able to provide informed consent to participate in study -Subjects with court appointed legal guardians will be included
Who cannot join
- History of neurological conditions that impair cognition
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Thresholds, Inc.
Chicago, Illinois, 60613
Mental Health Center of Greater Manchester
Manchester, New Hampshire, 03103
About this study
Official title: Cognitive Rehabilitation and Supported Employment for Severe Mental Illness
The purpose of this study is help people with serious mental illness and receiving vocational rehabilitation get and keep the job they want by improving their thinking skills, such as attention and memory, using computer exercises and other strategies. One half of the participants in the study will receive vocational rehabilitation and the exercises to improve thinking skills, and the other half will receive just vocational rehabilitation. All participants will receive an assessment of symptoms and thinking skills at the beginning of the study and 6, 12, and 24 months later. Work activity during the 24 months in the study will be collected. It is expected that those participants who receive the practice of their thinking skills will be more likely to get and keep the job they want compared with people who do not receive this treatment.
Read the detailed description
This randomized controlled trial is evaluating the effectiveness of a pilot-tested, manualized cognitive remediation intervention entitled the "Thinking Skills for Work Program" by comparing it to enhanced supported employment services in clients with severe mental illness (SMI) who are participants in high fidelity supported employment programs at the Greater Mental health Center of Manchester and Thresholds, Inc., Chicago, Il, but who have had difficulty getting or keeping jobs. Participants are randomized to either the Thinking Skills for Work (cognitive remediation +supported employment; CT+SE) or enhanced supported employment (E-SE), with cognitive, symptom, and quality of life assessments performed at baseline, 3 months (following the completion of the computerized cognitive training component of the Thinking Skills for Work program), 12 months, and 24 months, and employment data gathered over the full 2-year period. For the E-SE condition, supported employment services are enhanced by training provided to the employment specialists regarding to recognize cognitive problems related to work performance, and how employment specialists can teach clients coping strategies for managing these problems. Primary analyses will focus on testing the hypotheses that the Thinking Skills for Work Program (CT+SE) leads to better cognitive functioning and better competitive work outcomes over the 2-year follow-up period compared to the E-SE program.
- Conditions
- Schizophrenia, Schizoaffective Disorder, Major Depression, Bipolar Disorder, Anxiety Disorder
- Being tested
- Thinking Skills for Work Program, Supported Employment
- Keywords
- Schizophrenia, Chronic Mental Disorder, Employment, Cognitive remediation, Vocational rehabilitation
- Medical subject headings
- Schizophrenia, Psychotic Disorders, Depressive Disorder, Major, Bipolar Disorder, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thinking Skills for Work ProgramBehavioural
The Thinking Skills for Work includes assessment of cognitive strengths and weaknesses and their relationship with work history, computerized cognitive practice, compensatory strategy training, and integration of cognitive and supported employment services.
Supported EmploymentBehavioural
Supported Employment is an evidence based vocational rehabilitation program
| Study group | Role | What they receive |
|---|---|---|
| Supported Employment Only | Active comparator | Supported employment is an evidence based practice designed to help people with serious mental illness obtain competitive work. This vocational model adheres to the principles of zero inclusion, rapid job search, no prevocational training, attention to client preferences and integration with clinical services. Receives: Behavioral: Supported Employment |
| Thinking Skills for Work | Experimental | The Thinking Skills for Work Program includes 5 components delivered by a Cognitive Specialist who works collaboratively with the consumer's Employment Specialist: a) assessing the consumer's strengths and weaknesses in cognitive functioning, and analysis of the contribution of cognitive impairments and other factors to job losses and difficulties obtaining a job; b) teaching coping strategies for dealing with cognitive challenges associated with job search or maintaining a job; c) computer cognitive training involving cognitive exercises with a commercially available software program, which is designed to improve the broad range of cognitive skills through a combination of practice and strategy coaching by the Cognitive Specialist; d) job search planning; and e) job support consultation. Receives: Behavioral: Thinking Skills for Work Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
AMOUNT OF EMPLOYMENT
TOTAL HOURS OF COMPETITIVE EMPLOYMENT FROM BASELINE TO 24 MONTHS. TOTAL WEEKS OF EMPLOYMENT FROM BASELINE TO 24 MONTHS. TOTAL NUMBER OF JOBS HELD FROM BASELINE TO 24 MONTHS.
Measured: 24 months
Secondary outcomes (1)
EXECUTIVE FUNCTIONING AND MEMORY
CHANGE FROM BASELINE IN EXECUTIVE FUNCTIONING AND MEMORY AT 6 MONTHS USING THE MATRICS COGNITIVE ASSESSMENT BATTERY. CHANGE FROM BASELINE IN EXECUTIVE FUNCTIONING AND MEMORY AT 12 MONTHS USING THE MATRICS COGNITIVE ASSESSMENT BATTERY.. CHANGE FROM BASELINE IN EXECUTIVE FUNCTIONING AND MEMORY AT 24 MONTHS USING THE MATRICS COGNITIVE ASSESSMENT BATTERY.
Measured: BASELINE, 6, 12, 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 posted21 Aug 2013 (estimated)
- Study startApr 2006
- Primary completionOct 2009
- Study completionOct 2011
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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Susan R McGurk, Ph.D., Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01926613
- Sponsor's protocol ID
- MH077210
- Other IDs
- 1R01MH077210-01
- Acronym
- TSW
- Status last verified
- Aug 2013
- First submitted
- 19 Aug 2013
- Last updated
- 21 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
McGurk 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 25998278
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Rehabilitation and Supported Employment for Severe Mental Illness
- ClinicalTrials.gov ID
- NCT01926613
- Acronym / sponsor ID
- TSW / MH077210
- Conditions
- Schizophrenia, Schizoaffective Disorder, Major Depression, Bipolar Disorder, Anxiety Disorder
- Keywords
- Schizophrenia, Chronic Mental Disorder, Employment, Cognitive remediation, Vocational rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Apr 2006
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 21 Aug 2013 (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 help people with serious mental illness and receiving vocational rehabilitation get and keep the job they want by improving their thinking skills, such as attention and memory, using computer exercises and other strategies. One half of the participants in the study will receive vocational rehabilitation and the exercises to improve thinking skills, and the other half will receive just vocational rehabilitation. All participants will receive an assessment of symptoms and thinking skills at the beginning of the study and 6, 12, and 24 months later. Work activity during the 24 months in the study will be collected. It is expected that those participants who receive the practice of their thinking skills will be more likely to get and keep the job they want compared with people who do not receive this treatment.
Detailed description
This randomized controlled trial is evaluating the effectiveness of a pilot-tested, manualized cognitive remediation intervention entitled the "Thinking Skills for Work Program" by comparing it to enhanced supported employment services in clients with severe mental illness (SMI) who are participants in high fidelity supported employment programs at the Greater Mental health Center of Manchester and Thresholds, Inc., Chicago, Il, but who have had difficulty getting or keeping jobs. Participants are randomized to either the Thinking Skills for Work (cognitive remediation +supported employment; CT+SE) or enhanced supported employment (E-SE), with cognitive, symptom, and quality of life assessments performed at baseline, 3 months (following the completion of the computerized cognitive training component of the Thinking Skills for Work program), 12 months, and 24 months, and employment data gathered over the full 2-year period. For the E-SE condition, supported employment services are enhanced by training provided to the employment specialists regarding to recognize cognitive problems related to work performance, and how employment specialists can teach clients coping strategies for managing these problems. Primary analyses will focus on testing the hypotheses that the Thinking Skills for Work Program (CT+SE) leads to better cognitive functioning and better competitive work outcomes over the 2-year follow-up period compared to the E-SE program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supported Employment Only | Active comparator | Behavioral: Supported EmploymentSupported employment is an evidence based practice designed to help people with serious mental illness obtain competitive work. This vocational model adheres to the principles of zero inclusion, rapid job search, no prevocational training, attention to client preferences and integration with clinical services. |
| Thinking Skills for Work | Experimental | Behavioral: Thinking Skills for Work ProgramThe Thinking Skills for Work Program includes 5 components delivered by a Cognitive Specialist who works collaboratively with the consumer's Employment Specialist: a) assessing the consumer's strengths and weaknesses in cognitive functioning, and analysis of the contribution of cognitive impairments and other factors to job losses and difficulties obtaining a job; b) teaching coping strategies for dealing with cognitive challenges associated with job search or maintaining a job; c) computer cognitive training involving cognitive exercises with a commercially available software program, which is designed to improve the broad range of cognitive skills through a combination of practice and strategy coaching by the Cognitive Specialist; d) job search planning; and e) job support consultation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Chronic mental disorder
- Minimum age 18
- Unemployed
- Wants employment
- Must be a recipient of services at one of two participating agencies
Key exclusion criteria (1 listed)
- History of neurological conditions that impair 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 |
|---|---|---|
| Thinking Skills for Work ProgramThe Thinking Skills for Work includes assessment of cognitive strengths and weaknesses and their relationship with work history, computerized cognitive practice, compensatory strategy training, and integration of cognitive and supported employment services. | Behavioural | Thinking Skills for Work |
| Supported EmploymentSupported Employment is an evidence based vocational rehabilitation program | Behavioural | Supported Employment Only |
Primary outcome
AMOUNT OF EMPLOYMENT
Time frame: 24 months
TOTAL HOURS OF COMPETITIVE EMPLOYMENT FROM BASELINE TO 24 MONTHS. TOTAL WEEKS OF EMPLOYMENT FROM BASELINE TO 24 MONTHS. TOTAL NUMBER OF JOBS HELD FROM BASELINE TO 24 MONTHS.
1 secondary outcome
EXECUTIVE FUNCTIONING AND MEMORY
Time frame: BASELINE, 6, 12, 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 21 Aug 2013.
- Derived from this study: 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.
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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.
Susan R McGurk, Ph.D. principal investigator
Dartmouth-Hitchcock Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thinking Skills for Work Program and Supported Employment in people with Schizophrenia and Schizoaffective Disorder, run by Dartmouth-Hitchcock Medical Center at 2 sites 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 7 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 21 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
AMOUNT OF EMPLOYMENT (time frame: 24 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 NCT01926613, 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 21 Aug 2013.