NCT00261716

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2005

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 1, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 5, 2005

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
6.5 years until next milestone

Results Posted

Study results publicly available

August 3, 2016

Completed
Last Updated

August 3, 2016

Status Verified

June 1, 2016

Enrollment Period

3.7 years

First QC Date

December 1, 2005

Results QC Date

March 17, 2016

Last Update Submit

June 17, 2016

Conditions

Schizoaffective DisorderSchizophrenia

Keywords

clinical trialemploymentschizoaffective disorderschizophrenia

Outcome Measures

Primary Outcomes (3)

  • Obtained Employment

    Number of participants who obtained a competitive job

    18 months of study

  • Average Number of Days Worked

    Average number of total days each participant worked in the study

    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

    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

    18 months of the study

  • Association Between Employment Status and Psychiatric Symptoms as Measured on the Brief Psychiatric Rating Scale

    6,12, 18 months

  • Association Between Employment Status and Self-reported Life Satisfaction Measured on the Quality of Life Scale (Lehman)

    6,12, 18 months

  • Association Between Employment Status and Overall Adjustment as Rated on the Social Adjustment Scale II (Schooler)

    6, 12, and 18 months

Study Arms (2)

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

Behavioral: IPSBehavioral: 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

Behavioral: IPSBehavioral: IE

Interventions

IPSBEHAVIORAL

Individual Placement and Support Evidence based supported employment

IPS and IEIPS and VOMI
IEBEHAVIORAL

Four sessions of manualized illness education about schizophrenia/schizoaffective disorder (tailored to the participant diagnosis) prior to each course of a job search

IPS and IE
VOMIBEHAVIORAL

Four sessions of manualized motivational interviewing oriented to employment goals and concerns prior to each course of a job search

IPS and VOMI

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Organic brain disease
  • Physical illnesses that would preclude working

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Greater Los Angeles Healthcare System, West LA

West Los Angeles, California, 90073, United States

Location

MeSH Terms

Conditions

Psychotic DisordersSchizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Limitations and Caveats

Small sample size reflecting recruitment challenges

Results Point of Contact

Title
Shirley M. Glynn. Ph.D.
Organization
VAGLAHS at West Los Angeles
sglynn@ucla.edu
310-268-3939

Study Officials

  • Shirley M. Glynn, PhD

    VA Greater Los Angeles Healthcare System, West LA

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 1, 2005

First Posted

December 5, 2005

Study Start

January 1, 2005

Primary Completion

September 1, 2008

Study Completion

February 1, 2010

Last Updated

August 3, 2016

Results First Posted

August 3, 2016

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will share

Contact PI for access to data

Locations

US(1)