NCT00895258

Brief Summary

This study will compare the efficacy of two types of supportive treatments for a program called Individual Placement and Support, which helps people with severe mental illnesses find and keep jobs.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
163

participants targeted

Target at P50-P75 for phase_2 schizophrenia

Timeline
Completed

Started Apr 2008

Longer than P75 for phase_2 schizophrenia

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

April 1, 2008

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

May 7, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 8, 2009

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

June 19, 2014

Status Verified

June 1, 2014

Enrollment Period

5.9 years

First QC Date

May 7, 2009

Last Update Submit

June 18, 2014

Conditions

Keywords

Schizoaffective DisorderMajor Depressive DisorderSupported EmploymentWorkRehabilitationSevere Mental IllnessCognitive TrainingCognitive RehabilitationCognitive Remediation

Outcome Measures

Primary Outcomes (1)

  • Weeks worked

    Measured weekly for 2 years

Secondary Outcomes (2)

  • Cognition, based on the extended Measurement And Treatment Research to Improve Cognition in Schizophrenia (MATRICS) battery

    Measured at baseline and after 3, 6, 12, 18, and 24 months

  • Functioning

    Measured at baseline and after 3, 6, 12, 18, and 24 months

Study Arms (2)

IPS-CT

EXPERIMENTAL

Participants will receive individual placement and support (IPS) plus cognitive training (CT).

Behavioral: Individual placement and support plus cognitive training (IPS-CT)

IPS-ES

ACTIVE COMPARATOR

Participants will receive individual placement and support (IPS) plus enhanced support (ES).

Behavioral: Individual placement and support plus enhanced support (IPS-ES)

Interventions

One IPS plus one CT session each week for 12 weeks

IPS-CT

One IPS plus one ES session each week for 12 weeks

IPS-ES

Eligibility Criteria

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

You may qualify if:

  • Receiving psychiatric care at UCSD Outpatient Psychiatric Services
  • DSM-IV diagnosis of a severe mental illness, including schizophrenia, schizoaffective disorder, bipolar disorder, or major depressive disorder
  • Unemployed in the past 30 days, but stating a goal of work
  • Fluency and literacy in English

You may not qualify if:

  • Presence of dementia
  • Presence of mental retardation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCSD Outpatient Psychiatric Services

San Diego, California, 92103, United States

Location

Related Publications (1)

  • Burton CZ, Vella L, Twamley EW. Prospective memory, level of disability, and return to work in severe mental illness. Clin Neuropsychol. 2019 Apr;33(3):594-605. doi: 10.1080/13854046.2018.1436725. Epub 2018 Feb 25.

MeSH Terms

Conditions

SchizophreniaBipolar DisorderDepressionPsychotic DisordersDepressive Disorder, MajorMental Disorders

Interventions

Palliative CareCognitive Training

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersBipolar and Related DisordersMood DisordersBehavioral SymptomsBehaviorDepressive Disorder

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and ServicesNeurological RehabilitationRehabilitationAftercareContinuity of Patient Care

Study Officials

  • Elizabeth W. Twamley, PhD

    University of California, San Diego

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Psychiatry, UCSD

Study Record Dates

First Submitted

May 7, 2009

First Posted

May 8, 2009

Study Start

April 1, 2008

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

June 19, 2014

Record last verified: 2014-06

Locations