Trial Outcomes & Findings for Motivational Interviewing to Improve Work Outcomes in Schizophrenia (NCT NCT00261716)
NCT ID: NCT00261716
Last Updated: 2016-08-03
Results Overview
Number of participants who obtained a competitive job
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
38 participants
Primary outcome timeframe
18 months of study
Results posted on
2016-08-03
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
21
|
|
Overall Study
COMPLETED
|
11
|
11
|
|
Overall Study
NOT COMPLETED
|
6
|
10
|
Reasons for withdrawal
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
6
|
8
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
Baseline Characteristics
Motivational Interviewing to Improve Work Outcomes in Schizophrenia
Baseline characteristics by cohort
| Measure |
IPS+VOMI
n=17 Participants
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
|
IPS+IE
n=21 Participants
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
|
Total
n=38 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41.94 years
STANDARD_DEVIATION 11.08 • n=5 Participants
|
40.71 years
STANDARD_DEVIATION 12.72 • n=7 Participants
|
41.26 years
STANDARD_DEVIATION 11.87 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
8 participants
n=5 Participants
|
7 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
6 participants
n=5 Participants
|
8 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=5 Participants
|
3 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Education
12 years or less
|
5 participants
n=5 Participants
|
9 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Education
Some College
|
8 participants
n=5 Participants
|
10 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
Education
College Graduate
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Education
missing
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 18 months of studyNumber of participants who obtained a competitive job
Outcome measures
| Measure |
IPS+VOMI
n=17 Participants
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
|
IPS+IE
n=21 Participants
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
|
|---|---|---|
|
Obtained Employment
Never worked
|
10 participants
|
9 participants
|
|
Obtained Employment
Obtained at least one job
|
7 participants
|
12 participants
|
PRIMARY outcome
Timeframe: 18 months of studyAverage number of total days each participant worked in the study
Outcome measures
| Measure |
IPS+VOMI
n=17 Participants
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
|
IPS+IE
n=21 Participants
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
|
|---|---|---|
|
Average Number of Days Worked
|
93.47 days
Standard Deviation 163.7
|
110 days
Standard Deviation 147.8
|
PRIMARY outcome
Timeframe: 18 months of studyPopulation: Only included hours worked for participants who obtained a job (n=19 in the entire study)
Average number of hours worked per week among participants who obtained a job
Outcome measures
| Measure |
IPS+VOMI
n=7 Participants
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
|
IPS+IE
n=12 Participants
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
|
|---|---|---|
|
Average Number of Hours Worked Per Week For Those Who Worked
|
18.24 hours/worked per week
Standard Deviation 13.77
|
13.10 hours/worked per week
Standard Deviation 12.24
|
SECONDARY outcome
Timeframe: 18 months of the studyPopulation: 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
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
Outcome measures
| Measure |
IPS+VOMI
n=5 Participants
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
|
IPS+IE
n=10 Participants
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
|
|---|---|---|
|
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
|
2 participants
|
|
Obtained a Second Job if Lost First Job and Still Had at Least 2 Months in the Program
Held one job
|
3 participants
|
8 participants
|
SECONDARY outcome
Timeframe: 6,12, 18 monthsPopulation: 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
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
Outcome measures
| Measure |
IPS+VOMI
n=19 Participants
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
|
IPS+IE
n=19 Participants
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
|
|---|---|---|
|
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 7.40
|
42.20 units on a scale
Standard Deviation 7.77
|
|
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
|
41.92 units on a scale
Standard Deviation 8.69
|
|
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
|
37.75 units on a scale
Standard Deviation 3.54
|
SECONDARY outcome
Timeframe: 6,12, 18 monthsPopulation: 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
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).
Outcome measures
| Measure |
IPS+VOMI
n=19 Participants
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
|
IPS+IE
n=19 Participants
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
|
|---|---|---|
|
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
|
5.11 units on a scale
Standard Deviation 1.08
|
|
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
|
4.69 units on a scale
Standard Deviation 1.44
|
|
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 .93
|
5.44 units on a scale
Standard Deviation .53
|
SECONDARY outcome
Timeframe: 6, 12, and 18 monthsPopulation: 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
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.
Outcome measures
| Measure |
IPS+VOMI
n=19 Participants
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
|
IPS+IE
n=19 Participants
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
|
|---|---|---|
|
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 .52
|
4.29 units on a scale
Standard Deviation .77
|
|
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 .50
|
4.17 units on a scale
Standard Deviation .72
|
|
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 .35
|
4.0 units on a scale
Standard Deviation 1.0
|
Adverse Events
IPS+VOMI
Serious events: 6 serious events
Other events: 1 other events
Deaths: 0 deaths
IPS+IE
Serious events: 5 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
IPS+VOMI
n=17 participants at risk
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
|
IPS+IE
n=21 participants at risk
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
|
|---|---|---|
|
Psychiatric disorders
Hospitalization or ER visit
|
35.3%
6/17 • Number of events 7 • Length of Study--18 months
Information obtained from routine medical chart review and every 6 month interviews with participants
|
23.8%
5/21 • Number of events 5 • Length of Study--18 months
Information obtained from routine medical chart review and every 6 month interviews with participants
|
Other adverse events
| Measure |
IPS+VOMI
n=17 participants at risk
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
|
IPS+IE
n=21 participants at risk
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
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Torn tendon in finger
|
0.00%
0/17 • Length of Study--18 months
Information obtained from routine medical chart review and every 6 month interviews with participants
|
4.8%
1/21 • Number of events 1 • Length of Study--18 months
Information obtained from routine medical chart review and every 6 month interviews with participants
|
|
Psychiatric disorders
Increased psychiatric symptoms
|
0.00%
0/17 • Length of Study--18 months
Information obtained from routine medical chart review and every 6 month interviews with participants
|
14.3%
3/21 • Number of events 3 • Length of Study--18 months
Information obtained from routine medical chart review and every 6 month interviews with participants
|
|
Cardiac disorders
Elevated blood pressure
|
0.00%
0/17 • Length of Study--18 months
Information obtained from routine medical chart review and every 6 month interviews with participants
|
4.8%
1/21 • Number of events 1 • Length of Study--18 months
Information obtained from routine medical chart review and every 6 month interviews with participants
|
|
Gastrointestinal disorders
Rectal bleeding
|
0.00%
0/17 • Length of Study--18 months
Information obtained from routine medical chart review and every 6 month interviews with participants
|
4.8%
1/21 • Number of events 1 • Length of Study--18 months
Information obtained from routine medical chart review and every 6 month interviews with participants
|
|
Infections and infestations
Leg infection
|
5.9%
1/17 • Number of events 1 • Length of Study--18 months
Information obtained from routine medical chart review and every 6 month interviews with participants
|
0.00%
0/21 • Length of Study--18 months
Information obtained from routine medical chart review and every 6 month interviews with participants
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place