Schizoaffective DisorderPhase 3NCT00261716
Motivational Interviewing to Improve Work Outcomes in Schizophrenia
A Phase 3 study testing IPS, IE and VOMI in people with Schizoaffective Disorder and Schizophrenia, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Many persons with schizophrenia have difficulty getting and keeping a job. This study is designed to compare the benefits of four sessions of motivational interviewing or illness education in increasing employment rates accruing from participation in supported employment. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizoaffective Disorder, Schizophrenia
- What is being tested?
- IPS, IE and VOMI
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2005to Feb 2010
- Phase
- Phase 3
- 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
- Patient must have schizophrenia or schizoaffective disease
- Currently unemployed but want to get at least a part time job
- Be on a stable medication regimen and compliant with treatment
- Live within one hour of the hospital
- Be willing to have care transferred to the Schizophrenia Outpatient Clinic at VA Greater Los Angeles Healthcare System
Who cannot join
- Organic brain disease
- Physical illnesses that would preclude working
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Greater Los Angeles Healthcare System, West LA
West Los Angeles, California, 90073
About this study
Many persons with schizophrenia have difficulty getting and keeping a job. This study is designed to compare the benefits of four sessions of motivational interviewing or illness education in increasing employment rates accruing from participation in supported employment.
Read the detailed description
Many individuals with serious psychiatric illnesses wish to work, and yet employment rates for this population are lower than the general population (Cook \& Razanno, 2000). IPS is a type of supported employment intervention designed to assist individuals with serious psychiatric illnesses return to work. Over 20 randomized trials demonstrate that, in comparison to control conditions such as group therapy or referrals to traditional vocational rehabilitation services, IPS participants are three more times more likely to obtain a job during the study, and at least twice as likely to be competitively employed at any point in the study. Just as with the general population, the rewards of work for individuals with serious mental illness include considerably more than the financial remuneration. For example, employment appears to confer higher self-esteem, greater life satisfaction, and perhaps even better treatment compliance, symptom improvement, and insight in persons with psychiatric illnesses (Bell et al, 1996; Lysacker et al, 1995; Mueser et al, 1997; Bond et al, 1997; Kashner et al, 2002). Despite its demonstrated effectiveness, these IPS results could be improved. Most IPS participants are not competitively employed at any point in time, it takes an average of about four months to obtain a first job, a typical job lasts only approximately 20-25 weeks, and employment rates across the sample asymptote at about month 8 or 9 of participation in the trials. Furthermore, obtaining a first job seems to be an almost insurmountable impediment for approximately 35-40% of individuals in the trials, and these findings may be worse in individuals iwth schizophrenia (Twamely et al, 2003) . Motivational deficits may play a prominent role in explaining the limited benefits accruing from IPS in persons with serious and persisting psychiatric illnesses, especially in those with schizophrenia. Building a successful work life requires sustained effort over months and years (Palmer, 1989). After a period of unemployment, individuals must obtain their first reemployment position, and then transition to others as circumstances arise. Many persons with schizophrenia experience high degrees of negative symptoms, demoralization, and ambivalence, which likely all interfere with the persistent efforts required to initiate and maintain a successful vocational adjustment. Enhancing already validated vocational rehabilitation programs, such as IPS, with specific techniques to address motivational deficits may be essential to increasing employment rates among persons with schizophrenia. In this study, we tested a novel strategy designed to improve motivation for positive behavior change, motivational interviewing, adapted for work-related problems, in persons with schizophrenia. With the objective of improving work outcomes, we assigned 38 outpatients with schizophrenia or schizoaffective disorder to one of two 18 month psychosocial treatment groups, traditional Individual Placement and Support (IPS) with the addition of illness education (IE) about schizophrenia/schizoaffective disorder, as appropriate, or with the addition of Vocationally-oriented Motivational Interviewing (VOMI). We hypothesized that: 1) clients with schizophrenia who participated in IPS+VOMI would better vocational outcomes than IPS+IE clients. 2) If they are separated from their first job, clients with schizophrenia who participate in IPS+VOMI would be more likely to obtain a second job than clients who receive IPS+IE; and 3) Regardless of their treatment condition, working clients with schizophrenia would have greater social adjustment, symptoms, and life satisfaction than those who are not working.
- Conditions
- Schizoaffective Disorder, Schizophrenia
- Being tested
- IPS, IE, VOMI
- Keywords
- clinical trial, employment, schizoaffective disorder, schizophrenia
- Medical subject headings
- Psychotic Disorders, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPSBehavioural
Individual Placement and Support Evidence based supported employment
IEBehavioural
Four sessions of manualized illness education about schizophrenia/schizoaffective disorder (tailored to the participant diagnosis) prior to each course of a job search
VOMIBehavioural
Four sessions of manualized motivational interviewing oriented to employment goals and concerns prior to each course of a job search
| Study group | Role | What they receive |
|---|---|---|
| IPS and VOMI | Experimental | Individual Placement and Support (IPS), a form of evidence-based supported employment with 4 sessions of manualized vocationally-oriented motivational interviewing (VOMI) prior to each course of job searching Receives: Behavioral: IPS; Behavioral: VOMI |
| IPS and IE | Active comparator | Individual placement and support (IPS), a form of evidence-based supported employment with 4 sessions of education about schizophrenia/schizoaffective disorder (IE), as appropriate, prior to each course of job searching Receives: Behavioral: IPS; Behavioral: IE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Obtained Employment
Number of participants who obtained a competitive job
Measured: 18 months of study
Average Number of Days Worked
Average number of total days each participant worked in the study
Measured: 18 months of study
Average Number of Hours Worked Per Week For Those Who Worked
Average number of hours worked per week among participants who obtained a job
Measured: 18 months of study
Secondary outcomes (4)
Obtained a Second Job if Lost First Job and Still Had at Least 2 Months in the Program
Number of participants who obtained a second or third job if lost his/her first job but still had at least 2 months in the study
Measured: 18 months of the study
Association Between Employment Status and Psychiatric Symptoms as Measured on the Brief Psychiatric Rating Scale
Employment status at each major follow-up assessment period and psychiatric symptomatology as reflected in the Total Brief Psychiatric Rating Scale Score (Ventura J, et al., Training and quality assurance with the Structured Clinical Interview for DSM-IV (SCID-I/P). Psychiatry Research, 1998. 79(2): p. 163-173) with scale range from 24 to 168, with higher scores indicating greater symptomatology
Measured: 6,12, 18 months
Association Between Employment Status and Self-reported Life Satisfaction Measured on the Quality of Life Scale (Lehman)
Employment status at each major follow-up assessment period and self-reported Life Satisfaction (range from 1 (terrible) to 7 (delighted)) on the Quality of Life Scale (Lehman A, Kernan E, and Postrado L, Toolkit for Evaluating Quality of Life for Persons with Severe Mental Illness. 1995, Baltimore, MD: The Evaluation Center at HSRI).
Measured: 6,12, 18 months
Association Between Employment Status and Overall Adjustment as Rated on the Social Adjustment Scale II (Schooler)
Employment status at each major follow-up assessment period and overall adjustment as rated on the Social Adjustment Scale II (Schooler, N., G. Hogarty, and M. Weissman, Social Adjustment Scale II (SAS-II), in Resource Materials for Community Mental Health Program Evaluations, W.A. Hargreaves, C.C. Atkisson, and J.E. Sorenson, Editors. 1979, NIMH: Rockville, MD. p. 290-303), on a 1 (excellent adjustment ) to 7 (severe maladjustment) scale.
Measured: 6, 12, and 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2005 (estimated)
- Study startJan 2005
- Primary completionSep 2008
- Study completionFeb 2010
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.
- Other trials for Schizoaffective DisorderStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Shirley M. Glynn, PhD, Principal investigator, VA Greater Los Angeles Healthcare System, West LA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00261716
- Sponsor's protocol ID
- O3176-R
- Status last verified
- Jun 2016
- First submitted
- 1 Dec 2005
- Last updated
- 3 Aug 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: Contact PI for access to data
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motivational Interviewing to Improve Work Outcomes in Schizophrenia
- ClinicalTrials.gov ID
- NCT00261716
- Acronym / sponsor ID
- O3176-R
- Conditions
- Schizoaffective Disorder, Schizophrenia
- Keywords
- clinical trial, employment, schizoaffective disorder, schizophrenia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- Jan 2005
- Primary completion
- Sep 2008 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 5 Dec 2005 (estimated)
- Results
- Posted 3 Aug 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Many persons with schizophrenia have difficulty getting and keeping a job. This study is designed to compare the benefits of four sessions of motivational interviewing or illness education in increasing employment rates accruing from participation in supported employment.
Detailed description
Many individuals with serious psychiatric illnesses wish to work, and yet employment rates for this population are lower than the general population (Cook \& Razanno, 2000). IPS is a type of supported employment intervention designed to assist individuals with serious psychiatric illnesses return to work. Over 20 randomized trials demonstrate that, in comparison to control conditions such as group therapy or referrals to traditional vocational rehabilitation services, IPS participants are three more times more likely to obtain a job during the study, and at least twice as likely to be competitively employed at any point in the study. Just as with the general population, the rewards of work for individuals with serious mental illness include considerably more than the financial remuneration. For example, employment appears to confer higher self-esteem, greater life satisfaction, and perhaps even better treatment compliance, symptom improvement, and insight in persons with psychiatric illnesses (Bell et al, 1996; Lysacker et al, 1995; Mueser et al, 1997; Bond et al, 1997; Kashner et al, 2002). Despite its demonstrated effectiveness, these IPS results could be improved. Most IPS participants are not competitively employed at any point in time, it takes an average of about four months to obtain a first job, a typical job lasts only approximately 20-25 weeks, and employment rates across the sample asymptote at about month 8 or 9 of participation in the trials. Furthermore, obtaining a first job seems to be an almost insurmountable impediment for approximately 35-40% of individuals in the trials, and these findings may be worse in individuals iwth schizophrenia (Twamely et al, 2003) . Motivational deficits may play a prominent role in explaining the limited benefits accruing from IPS in persons with serious and persisting psychiatric illnesses, especially in those with schizophrenia. Building a successful work life requires sustained effort over months and years (Palmer, 1989). After a period of unemployment, individuals must obtain their first reemployment position, and then transition to others as circumstances arise. Many persons with schizophrenia experience high degrees of negative symptoms, demoralization, and ambivalence, which likely all interfere with the persistent efforts required to initiate and maintain a successful vocational adjustment. Enhancing already validated vocational rehabilitation programs, such as IPS, with specific techniques to address motivational deficits may be essential to increasing employment rates among persons with schizophrenia. In this study, we tested a novel strategy designed to improve motivation for positive behavior change, motivational interviewing, adapted for work-related problems, in persons with schizophrenia. With the objective of improving work outcomes, we assigned 38 outpatients with schizophrenia or schizoaffective disorder to one of two 18 month psychosocial treatment groups, traditional Individual Placement and Support (IPS) with the addition of illness education (IE) about schizophrenia/schizoaffective disorder, as appropriate, or with the addition of Vocationally-oriented Motivational Interviewing (VOMI). We hypothesized that: 1) clients with schizophrenia who participated in IPS+VOMI would better vocational outcomes than IPS+IE clients. 2) If they are separated from their first job, clients with schizophrenia who participate in IPS+VOMI would be more likely to obtain a second job than clients who receive IPS+IE; and 3) Regardless of their treatment condition, working clients with schizophrenia would have greater social adjustment, symptoms, and life satisfaction than those who are not working.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IPS and VOMI | Experimental | Behavioral: IPS, Behavioral: VOMIIndividual Placement and Support (IPS), a form of evidence-based supported employment with 4 sessions of manualized vocationally-oriented motivational interviewing (VOMI) prior to each course of job searching |
| IPS and IE | Active comparator | Behavioral: IPS, Behavioral: IEIndividual placement and support (IPS), a form of evidence-based supported employment with 4 sessions of education about schizophrenia/schizoaffective disorder (IE), as appropriate, prior to each course of job searching |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient must have schizophrenia or schizoaffective disease
- Currently unemployed but want to get at least a part time job
- Be on a stable medication regimen and compliant with treatment
- Live within one hour of the hospital
- Be willing to have care transferred to the Schizophrenia Outpatient Clinic at VA Greater Los Angeles Healthcare System
Key exclusion criteria (2 listed)
- Organic brain disease
- Physical illnesses that would preclude working
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 |
|---|---|---|
| IPSIndividual Placement and Support Evidence based supported employment | Behavioural | IPS and IE, IPS and VOMI |
| IEFour sessions of manualized illness education about schizophrenia/schizoaffective disorder (tailored to the participant diagnosis) prior to each course of a job search | Behavioural | IPS and IE |
| VOMIFour sessions of manualized motivational interviewing oriented to employment goals and concerns prior to each course of a job search | Behavioural | IPS and VOMI |
Primary outcome
Obtained Employment
Time frame: 18 months of study
Number of participants who obtained a competitive job
Average Number of Days Worked
Time frame: 18 months of study
Average number of total days each participant worked in the study
Average Number of Hours Worked Per Week For Those Who Worked
Time frame: 18 months of study
Average number of hours worked per week among participants who obtained a job
4 secondary outcomes
Obtained a Second Job if Lost First Job and Still Had at Least 2 Months in the Program
Time frame: 18 months of the study
Association Between Employment Status and Psychiatric Symptoms as Measured on the Brief Psychiatric Rating Scale
Time frame: 6,12, 18 months
Association Between Employment Status and Self-reported Life Satisfaction Measured on the Quality of Life Scale (Lehman)
Time frame: 6,12, 18 months
Association Between Employment Status and Overall Adjustment as Rated on the Social Adjustment Scale II (Schooler)
Time frame: 6, 12, and 18 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Contact PI for access to data
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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.
Shirley M. Glynn, PhD principal investigator
VA Greater Los Angeles Healthcare System, West LA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing IPS, IE and VOMI in people with Schizoaffective Disorder and Schizophrenia, run by VA Office of Research and Development 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 5 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 3 Aug 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 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Aug 2016). 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?
Obtained Employment (time frame: 18 months of study). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Aug 2016.