Schizoaffective Disorder, Schizophrenia
Conditions
Keywords
clinical trial, employment, schizoaffective disorder, schizophrenia
Brief 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.
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.
Interventions
BEHAVIORALIE
Four sessions of manualized illness education about schizophrenia/schizoaffective disorder (tailored to the participant diagnosis) prior to each course of a job search
BEHAVIORALVOMI
Four sessions of manualized motivational interviewing oriented to employment goals and concerns prior to each course of a job search
BEHAVIORALIPS
Individual Placement and Support Evidence based supported employment
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Organic brain disease * Physical illnesses that would preclude working
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Obtained Employment | 18 months of study | Number of participants who obtained a competitive job |
| Average Number of Days Worked | 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 | 18 months of study | Average number of hours worked per week among participants who obtained a job |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Obtained a Second Job if Lost First Job and Still Had at Least 2 Months in the Program | 18 months of the study | 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 |
| Association Between Employment Status and Overall Adjustment as Rated on the Social Adjustment Scale II (Schooler) | 6, 12, and 18 months | 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. |
| Association Between Employment Status and Psychiatric Symptoms as Measured on the Brief Psychiatric Rating Scale | 6,12, 18 months | 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 |
| Association Between Employment Status and Self-reported Life Satisfaction Measured on the Quality of Life Scale (Lehman) | 6,12, 18 months | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| IPS+VOMI 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
Individual Placement and Support (IPS): Evidence based supported employment
Vocationally-Oriented Motivational Interviewing (VOMI): Four sessions of manualized motivational interviewing oriented to employment goals and concerns prior to each course of a job search | 17 |
| IPS+IE 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
Individual Placement and Support (IPS): Evidence based supported employment
Illness Education (IE): Four sessions of manualized illness education about schizophrenia/schizoaffective disorder (tailored to the participant diagnosis) prior to each course of a job search | 21 |
| Total | 38 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 2 |
| Overall Study | Withdrawal by Subject | 6 | 8 |
Baseline characteristics
| Characteristic | IPS+VOMI | IPS+IE | Total |
|---|---|---|---|
| Age, Continuous | 41.94 years STANDARD_DEVIATION 11.08 | 40.71 years STANDARD_DEVIATION 12.72 | 41.26 years STANDARD_DEVIATION 11.87 |
| Education 12 years or less | 5 participants | 9 participants | 14 participants |
| Education College Graduate | 3 participants | 2 participants | 5 participants |
| Education missing | 1 participants | 0 participants | 1 participants |
| Education Some College | 8 participants | 10 participants | 18 participants |
| Race/Ethnicity, Customized African American | 6 participants | 8 participants | 14 participants |
| Race/Ethnicity, Customized Asian | 1 participants | 3 participants | 4 participants |
| Race/Ethnicity, Customized Caucasian | 8 participants | 7 participants | 15 participants |
| Race/Ethnicity, Customized Hispanic | 2 participants | 2 participants | 4 participants |
| Race/Ethnicity, Customized Other | 0 participants | 1 participants | 1 participants |
| Sex: Female, Male Female | 6 Participants | 2 Participants | 8 Participants |
| Sex: Female, Male Male | 11 Participants | 19 Participants | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 17 | 6 / 21 |
| serious Total, serious adverse events | 6 / 17 | 5 / 21 |
Outcome results
Primary
Average Number of Days Worked
Average number of total days each participant worked in the study
Time frame: 18 months of study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IPS+VOMI | Average Number of Days Worked | 93.47 days | Standard Deviation 163.7 |
| IPS+IE | Average Number of Days Worked | 110 days | Standard Deviation 147.8 |
Comparison: intent to treat analysisp-value: 0.75t-test, 2 sided
Primary
Average Number of Hours Worked Per Week For Those Who Worked
Average number of hours worked per week among participants who obtained a job
Time frame: 18 months of study
Population: Only included hours worked for participants who obtained a job (n=19 in the entire study)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IPS+VOMI | Average Number of Hours Worked Per Week For Those Who Worked | 18.24 hours/worked per week | Standard Deviation 13.77 |
| IPS+IE | Average Number of Hours Worked Per Week For Those Who Worked | 13.10 hours/worked per week | Standard Deviation 12.24 |
p-value: 0.41t-test, 2 sided
Primary
Obtained Employment
Number of participants who obtained a competitive job
Time frame: 18 months of study
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IPS+VOMI | Obtained Employment | Obtained at least one job | 7 participants |
| IPS+VOMI | Obtained Employment | Never worked | 10 participants |
| IPS+IE | Obtained Employment | Obtained at least one job | 12 participants |
| IPS+IE | Obtained Employment | Never worked | 9 participants |
Comparison: Intent to treat analysisp-value: 0.33Chi-squared
Secondary
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.
Time frame: 6, 12, and 18 months
Population: Number of individuals working within one month of assessment point varies by follow up point; total n=38 at baseline; total n=25 analyzed at 6 months; total n= 16 analyzed at 12 months; total n = 17 analyzed at 18 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IPS+VOMI | Association Between Employment Status and Overall Adjustment as Rated on the Social Adjustment Scale II (Schooler) | 6 month | 3.63 units on a scale | Standard Deviation 0.52 |
| IPS+VOMI | Association Between Employment Status and Overall Adjustment as Rated on the Social Adjustment Scale II (Schooler) | 12 months | 3.75 units on a scale | Standard Deviation 0.5 |
| IPS+VOMI | Association Between Employment Status and Overall Adjustment as Rated on the Social Adjustment Scale II (Schooler) | 18 months | 3.13 units on a scale | Standard Deviation 0.35 |
| IPS+IE | Association Between Employment Status and Overall Adjustment as Rated on the Social Adjustment Scale II (Schooler) | 6 month | 4.29 units on a scale | Standard Deviation 0.77 |
| IPS+IE | Association Between Employment Status and Overall Adjustment as Rated on the Social Adjustment Scale II (Schooler) | 12 months | 4.17 units on a scale | Standard Deviation 0.72 |
| IPS+IE | Association Between Employment Status and Overall Adjustment as Rated on the Social Adjustment Scale II (Schooler) | 18 months | 4.0 units on a scale | Standard Deviation 1 |
Comparison: Intent to treat analysisp-value: 0.19Mixed Models Analysis
p-value: 0.09Mixed Models Analysis
p-value: 0.39Mixed Models Analysis
Secondary
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
Time frame: 6,12, 18 months
Population: Number of individuals working within one month of assessment point varies by follow up point; total n=38 at baseline; total n=23 analyzed at 6 months; total n= 19 analyzed at 12 months; total n = 16 analyzed at 18 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IPS+VOMI | Association Between Employment Status and Psychiatric Symptoms as Measured on the Brief Psychiatric Rating Scale | 18 months | 39.63 units on a scale | Standard Deviation 5.83 |
| IPS+VOMI | Association Between Employment Status and Psychiatric Symptoms as Measured on the Brief Psychiatric Rating Scale | 6 month | 39.88 units on a scale | Standard Deviation 7.4 |
| IPS+VOMI | Association Between Employment Status and Psychiatric Symptoms as Measured on the Brief Psychiatric Rating Scale | 12 months | 41.17 units on a scale | Standard Deviation 5.49 |
| IPS+IE | Association Between Employment Status and Psychiatric Symptoms as Measured on the Brief Psychiatric Rating Scale | 12 months | 41.92 units on a scale | Standard Deviation 8.69 |
| IPS+IE | Association Between Employment Status and Psychiatric Symptoms as Measured on the Brief Psychiatric Rating Scale | 18 months | 37.75 units on a scale | Standard Deviation 3.54 |
| IPS+IE | Association Between Employment Status and Psychiatric Symptoms as Measured on the Brief Psychiatric Rating Scale | 6 month | 42.20 units on a scale | Standard Deviation 7.77 |
Comparison: Intent to treat analysisp-value: 0.37Mixed Models Analysis
p-value: 0.16Mixed Models Analysis
p-value: 0.63Mixed Models Analysis
Secondary
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).
Time frame: 6,12, 18 months
Population: Number of individuals working within one month of assessment point varies by follow up point; total n=38 at baseline; total n=26 analyzed at 6 months; total n= 19 analyzed at 12 months; total n = 17 analyzed at 18 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IPS+VOMI | Association Between Employment Status and Self-reported Life Satisfaction Measured on the Quality of Life Scale (Lehman) | 6 month | 5.00 units on a scale | Standard Deviation 1.07 |
| IPS+VOMI | Association Between Employment Status and Self-reported Life Satisfaction Measured on the Quality of Life Scale (Lehman) | 12 months | 5.50 units on a scale | Standard Deviation 1.05 |
| IPS+VOMI | Association Between Employment Status and Self-reported Life Satisfaction Measured on the Quality of Life Scale (Lehman) | 18 months | 5.0 units on a scale | Standard Deviation 0.93 |
| IPS+IE | Association Between Employment Status and Self-reported Life Satisfaction Measured on the Quality of Life Scale (Lehman) | 6 month | 5.11 units on a scale | Standard Deviation 1.08 |
| IPS+IE | Association Between Employment Status and Self-reported Life Satisfaction Measured on the Quality of Life Scale (Lehman) | 12 months | 4.69 units on a scale | Standard Deviation 1.44 |
| IPS+IE | Association Between Employment Status and Self-reported Life Satisfaction Measured on the Quality of Life Scale (Lehman) | 18 months | 5.44 units on a scale | Standard Deviation 0.53 |
Comparison: intent to treat analysisp-value: 0.62Mixed Models Analysis
p-value: 0.65Mixed Models Analysis
p-value: 0.81Mixed Models Analysis
Secondary
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
Time frame: 18 months of the study
Population: Includes only participants who obtained at least one job and had at least 2 months left if they lost/left that job; 2 individuals in each condition held the same job for almost the whole program and thus could not contribute data here
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IPS+VOMI | Obtained a Second Job if Lost First Job and Still Had at Least 2 Months in the Program | Held one job | 3 participants |
| IPS+VOMI | Obtained a Second Job if Lost First Job and Still Had at Least 2 Months in the Program | Held more than one job | 2 participants |
| IPS+IE | Obtained a Second Job if Lost First Job and Still Had at Least 2 Months in the Program | Held one job | 8 participants |
| IPS+IE | Obtained a Second Job if Lost First Job and Still Had at Least 2 Months in the Program | Held more than one job | 2 participants |
Comparison: intent to treat --all participants who obtained at least one jobp-value: >0.05Fisher Exact
p-value: >0.05Fisher Exact