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Motivational Interviewing to Improve Work Outcomes in Schizophrenia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT00261716
First received: December 1, 2005
Last updated: June 17, 2016
Last verified: June 2016
Results First Received: March 17, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Schizoaffective Disorder
Schizophrenia
Interventions: Behavioral: IPS
Behavioral: IE
Behavioral: VOMI

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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


Participant Flow:   Overall Study
    IPS+VOMI     IPS+IE  
STARTED     17     21  
COMPLETED     11     11  
NOT COMPLETED     6     10  
Withdrawal by Subject                 6                 8  
Lost to Follow-up                 0                 2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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

Total Total of all reporting groups

Baseline Measures
    IPS+VOMI     IPS+IE     Total  
Number of Participants  
[units: participants]
  17     21     38  
Age  
[units: years]
Mean (Standard Deviation)
  41.94  (11.08)     40.71  (12.72)     41.26  (11.87)  
Gender  
[units: participants]
     
Female     6     2     8  
Male     11     19     30  
Race/Ethnicity, Customized  
[units: participants]
     
Caucasian     8     7     15  
African American     6     8     14  
Asian     1     3     4  
Hispanic     2     2     4  
Other     0     1     1  
Education  
[units: participants]
     
12 years or less     5     9     14  
Some College     8     10     18  
College Graduate     3     2     5  
missing     1     0     1  



  Outcome Measures
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1.  Primary:   Obtained Employment   [ Time Frame: 18 months of study ]

2.  Primary:   Average Number of Days Worked   [ Time Frame: 18 months of study ]

3.  Primary:   Average Number of Hours Worked Per Week For Those Who Worked   [ Time Frame: 18 months of study ]

4.  Secondary:   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 ]

5.  Secondary:   Association Between Employment Status and Psychiatric Symptoms as Measured on the Brief Psychiatric Rating Scale   [ Time Frame: 6,12, 18 months ]

6.  Secondary:   Association Between Employment Status and Self-reported Life Satisfaction Measured on the Quality of Life Scale (Lehman)   [ Time Frame: 6,12, 18 months ]

7.  Secondary:   Association Between Employment Status and Overall Adjustment as Rated on the Social Adjustment Scale II (Schooler)   [ Time Frame: 6, 12, and 18 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Small sample size reflecting recruitment challenges


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Shirley M. Glynn. Ph.D.
Organization: VAGLAHS at West Los Angeles
phone: 310-268-3939
e-mail: sglynn@ucla.edu



Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00261716     History of Changes
Other Study ID Numbers: O3176-R
Study First Received: December 1, 2005
Results First Received: March 17, 2016
Last Updated: June 17, 2016
Health Authority: United States: Federal Government