Supported Employment: Motivational Enhancement for Entry and Outcome

Bipolar Disorder Clinical Trial

Official title:

Supported Employment: Motivational Enhancement for Entry and Outcome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01041976
• Other study ID #: D7306-R
• Status: Completed
• Phase: Phase 2
• First received: December 31, 2009
• Last updated: February 8, 2016
• Start date: January 2011
• Est. completion date: September 2015

Study information

• Verified date: February 2016
• 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

The purpose of this study is to compare 6 monthly counseling sessions to 6 monthly information sessions on Veterans' decisions to (a) participate in vocational rehabilitation services and (b) become employed.

Description:

Approximately 85-90% of those with serious mental illness are unemployed (9, 10). This level of unemployment exists despite the finding that, among people who have a psychiatric disability and are unemployed, 55-61% desire employment, with the total reaching 75% when concern about losing benefits was taken into account (1, 2). The rewards of employment for adults with SMI are greater than simply an increase in financial resources. Studies have found that people with serious mental illness who worked competitively scored higher on measures of self-esteem, satisfaction with finances, leisure, and overall life satisfaction compared to those worked little or not at all (11). Supported employment (SE) has been more effective than any other vocational rehabilitation approach for this population (3, 4) and the VA has mandated that SE be integrated into all current VHA Compensated Work Therapy (CWT) programs (VHA Directive 2007-005). Two areas of concern include (a) national utilization of SE services is low (13), and (b) the percentage of SE participants who obtain at least one job during the studies averages 56% even though everyone who enters the program expressed an interest in working (13).

Motivational interviewing (MI) is an evidence-based practice that has been effective in enhancing a range of clinical services (6), but has just recently been applied to employment and vocational services by Drebing et al. (7) and Glynn et al (8).

The proposed project is a randomized trial of Adapted Motivational Interviewing for Supported Employment (AMI-SE) provided to Veterans and their significant others (family members or key friends) in order to address the internal and external barriers to the Veteran enrolling in supported employment and returning to work.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 168
• Est. completion date: September 2015
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Eligible to receive VA services

• Diagnosis of serious mental illness: schizophrenia, schizoaffective, psychosis NOS, bipolar disorder, or depression with psychotic features

• Currently unemployed

• Not currently enrolled in Supported Employment services

• Expects to stay within 100 miles of Bedford, MA for the next 18 months

• Has a significant other (friend or family member) who is also willing to participate (a criterion required only from March 2011 to March 2012 of the recruitment period)

Exclusion Criteria:

• Currently in prison

• Not able to provide informed consent

• Not able to speak and understand English

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Disorder
• Disease
• Mental Disorders
• Psychotic Disorders
• Unemployment

Intervention

Behavioral:
• Adapted Motivational Interviewing (AMI)
Veterans assigned to the AMI condition will be scheduled for up to 6 sessions over 6 months. Up to 3 of these 6 sessions will be joint sessions with the Veteran's significant other (if available). Sessions will utilize a variety of motivational enhancement strategies including evocative questions, importance and confidence scales, collaborative problem solving, and planning.
• Support and Education for Recovery (SER)
Veterans assigned to the control condition will be seen for 6 sessions over 6 months of basic support and education about VA and non-VA psychiatric rehabilitation and recovery services. Up to 3 of these 6 sessions will be joint sessions with the Veteran's significant other (if available). The session topics include information about Bedford VA and Boston VA recovery services, as well as those offered by local non-profits.

Locations

Country	Name	City	State
United States	Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA	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	Participation in Vocational Rehabilitation Services	Yes/No: Did veteran complete an intake for a VA Supported Employment program at any time from randomization to 18 month follow-up.; Outcome: Number of participants who completed an intake for VA Supported Employment program at any time from randomization to 18 month follow-up.	18 months	No
Secondary	Employment	Yes/No: Did veteran work at least one day in a competitive job at any time from randomization to 18 month follow-up.; Outcome: Number of participants who worked at least one day in a competitive job at any time from randomization to 18 month follow-up.	18 months	No