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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00223834
Other study ID # E3436R
Secondary ID
Status Completed
Phase N/A
First received September 14, 2005
Last updated March 11, 2008
Start date March 2005
Est. completion date September 2007

Study information

Verified date March 2008
Source VA Office of Research and Development
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

This study will examine the barriers and supports for entering and receiving work-related services for veterans with a serious mental illness. It will also determine the effectiveness of a brief motivational interviewing intervention designed to help veterans receive these services.


Description:

Randomized clinical trials and naturalistic studies show that among patients meeting criteria for chronic mental illness, those participating in vocational rehabilitation (VR) have significantly reduced days of inpatient hospitalization. Unfortunately, the majority of eligible adults fail to enter VR and almost half of those who do, drop out or are involuntarily discharged. The reasons for nonparticipation and drop out and their impact on rehabilitation outcomes are poorly understood.

The study will provide needed naturalistic data documenting:

1. the way in which barriers function to reduce entry to services and contribute to the high rate of dropout,

2. the outcomes associated with different patterns of participation, and

3. relative rates of entry and retention in a non-VHA VR exemplar of the Intensive Placement and Support (IPS) model at the Manchester Mental Health Center in Manchester, New Hampshire.

While we need to know more about these "barriers" in order to develop the range of appropriate interventions, the enhancement of client motivation for work and rehabilitation is likely to have a positive impact both on entry and sustained compliance. We are proposing a random assignment single blind trial of a brief Motivational Interviewing (MI) intervention designed to address the low entry and retention rates of veterans with Serious Mental Illness (SMI) in Veterans Health Administration's (VHA) VR services.


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date September 2007
Est. primary completion date January 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria:

- Current diagnosis of serious mental illness, present for at least 2 years

- Is unemployed or underemployed

- Current episode of un/underemployment is at least 3 months

- Enrolled to receive services at study site

Exclusion Criteria:

- Over the age of 55

- Non-English speaker

- Mini-Mental score of less than 20

- Planning to move more than 30 miles from study site in the next 18 months

- Previously screened for this study

- Currently or previously involved in other research studies which may impact variables relevant to this study

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
single session of Motivational Interviewing


Locations

Country Name City State
United States Edith Nourse Rogers Memorial Veterans Hospital, Bedford Bedford Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Entry and Retention in Vocational Rehabilitation 18 months post intervention No
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