Brief Summary

The purpose of this study is to determine whether offering an evidence-based package of employment supports integrated with mental health services has a positive impact on employment and clinical recovery, and delays or diminishes the need for disability benefits.

Trial Health

On Track

Trial Health Score

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

Enrollment

3,000

participants targeted

Target at P75+ for not_applicable

Timeline

Completed

Started Dec 2017

Longer than P75 for not_applicable

Geographic Reach

1 country

52 active sites

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

4.3 years study duration

Study Start

First participant enrolled

December 2, 2017

Completed

10 months until next milestone

First Submitted

Initial submission to the registry

September 19, 2018

Completed

5 days until next milestone

First Posted

Study publicly available on registry

September 24, 2018

Completed

3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2022

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2022

Completed

Last Updated

April 14, 2022

Status Verified

April 1, 2022

Enrollment Period

4.3 years

First QC Date

September 19, 2018

Last Update Submit

April 13, 2022

Conditions

Mental Impairment

Outcome Measures

Primary Outcomes (1)

Employment
Whether participant is employed in a paying job at any time during the 36 month study period. Assessed via quarterly computer-assisted telephone interviews.
36 months

Secondary Outcomes (9)

Employment (Competitive)
36 months
Total Hours Worked
36 months
Days to First Job
36 months
Months Employed
36 months
Job Tenure
36 months
+4 more secondary outcomes

Study Arms (3)

Full Service Treatment

EXPERIMENTAL

The Full Service Arm receives the Individual Placement and Support (IPS) model of employment services integrated with behavioral health services and care management services, as well as Medication Management Support (MMS) from a Nurse Care Coordinator (NCC).

Behavioral: Full Service

Basic Service Treatment

EXPERIMENTAL

The Basic Service Arm receives the Individual Placement and Support (IPS) model of employment services integrated with behavioral health services and care management services.

Behavioral: Basic Service

Usual Services

NO INTERVENTION

Members of the Usual Service group seek services as they normally would (or would not) in their community. At the time of randomization, each Usual Services group member receives a comprehensive manual describing mental health and employment services in their local community, as well as state and national resources.

Interventions

Full ServiceBEHAVIORAL

Receive Individual Placement and Support (IPS) model of employment services, behavioral health services, care management services, and Medication Management Support provided by a Nurse Care Coordinator (NCC).

Full Service Treatment

Basic ServiceBEHAVIORAL

Receive Individual Placement and Support (IPS) model of employment services, behavioral health services, and care management services.

Basic Service Treatment

Eligibility Criteria

Age18 Years - 49 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64)

You may qualify if:

Individuals denied Social Security disability benefits (SSDI or SSI)
Individuals alleging a mental impairment
Live in Community Mental Health Agency (CMHA) catchment area
Legally competent
Express desire to improve work situation

You may not qualify if:

Intellectual disability
Reside in a nursing home or custodial institution
Already receiving supported employment services from CMHA site

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Westatlead
United States Social Security Administrationcollaborator

Study Sites (52)

Penny Lane Centers

Lancaster, California, 93535, United States

Location

Mental Health Center of Denver

Denver, Colorado, 80204, United States

Location

Boley Centers

St. Petersburg, Florida, 33713, United States

Location

Trilogy

Chicago, Illinois, 60623, United States

Location

Trilogy

Chicago, Illinois, 60626, United States

Location

Bridgeway

Galesburg, Illinois, 61401, United States

Location

Bridgeway

Kewanee, Illinois, 61443, United States

Location

Bridgeway

Loves Park, Illinois, 61111, United States

Location

Bridgeway

Macomb, Illinois, 61455, United States

Location

Bridgeway

Normal, Illinois, 61761, United States

Location

Bridgeway

Pekin, Illinois, 61554, United States

Location

Mental Health Association of South Central Kansas

Wichita, Kansas, 67208, United States

Location

Communicare

Bardstown, Kentucky, 40004, United States

Location

Communicare

Brandenburg, Kentucky, 40108, United States

Location

Communicare

Elizabethtown, Kentucky, 42701, United States

Location

Communicare

Hardinsburg, Kentucky, 40143, United States

Location

Communicare

Hodgenville, Kentucky, 42748, United States

Location

Communicare

Lebanon, Kentucky, 40033, United States

Location

Communicare

Leitchfield, Kentucky, 42754, United States

Location

Communicare

Radcliff, Kentucky, 40160, United States

Location

Cornerstone Montgomery

Bethesda, Maryland, 20814, United States

Location

Pathways

Hollywood, Maryland, 20636, United States

Location

Cornerstone Montgomery

Rockville, Maryland, 20850, United States

Location

Cornerstone Montgomery

Silver Spring, Maryland, 20902, United States

Location

Pathways

Upper Marlboro, Maryland, 20775, United States

Location

Pathways

Waldorf, Maryland, 20601, United States

Location

Vinfen

Boston, Massachusetts, 02118, United States

Location

RISE

Minneapolis, Minnesota, 55418, United States

Location