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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02784938
Other study ID # 90RT5029-01-00 R3
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 11, 2015
Est. completion date May 12, 2020

Study information

Verified date September 2020
Source Boston University Charles River Campus
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this project is to evaluate a promising peer-run psycho-educational group intervention titled "Vocational Empowerment Photovoice (VEP)" that aims to empower individuals with the most disabling psychiatric disabilities to engage in vocational services and pursue employment through the enhancement of their vocational hope, sense of vocational identity, work motivation, work-related self-efficacy, and capacity to deal with psychiatric stigma and discrimination.


Description:

The purpose of this project is to evaluate a promising peer-run psycho-educational group intervention titled "Vocational Empowerment Photovoice (VEP)" that aims to empower individuals with the most disabling psychiatric disabilities to engage in vocational services and pursue employment through the enhancement of their vocational hope, sense of vocational identity, work motivation, work-related self-efficacy, and capacity to deal with psychiatric stigma and discrimination. The VEP program was designed and pilot tested with a small randomized study (n=51) as part of a National Institute of Disability and Rehabilitation Research (NIDRR) funded research and training center (RTC) on Improving the Employment Outcomes (2009-2014). VEP is a 10-week peer-run program enhanced with 3 group booster sessions and the availability of weekly individual support provided by the VEP peer-leaders in keeping with each participant's formulated vocational goals. The researchers propose to evaluate the effectiveness of the VEP intervention using a large multi-site randomized controlled trial (RCT) with a total of 160 individuals who are not engaged in vocational services or working, but express such interests. The RCT will be carried out at 2 different mental health agencies (Thresholds in Chicago, IL and Pilgrim Psychiatric Center in Long Island, NY) both of which provide supported employment services. Eighty individuals will be recruited at each of these two study sites and will be assessed at baseline and 4 post baseline follow-up points. The efficacy of the VEP intervention will be tested in regards to two types of outcomes: a) extrinsic (for example, engagement in employment services, job-seeking activities, or employment), and b) intrinsic (for example, enhanced vocational hope, sense of vocational identity, work motivation, work-related self-efficacy). The researchers propose a small qualitative sub-study to inform future implementation and scaling up of VEP based on its effectiveness. Upon completion of each wave of the RCT the researchers will conduct an approximately 90-minutes focus group with participants in the VEP program and individual interviews with the VEP peer leaders. At the conclusion of the RCT at each collaborating site, the researchers will conduct individual interviews with the VEP supervisor(s), research staff and agency senior manager(s) familiar with the study.

The study is currently approved for the Thresholds site and recruitment is under way at this site.


Recruitment information / eligibility

Status Completed
Enrollment 147
Est. completion date May 12, 2020
Est. primary completion date May 12, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. are 18 or older

2. have a DSM-IV diagnosis of serious mental illness, including dual diagnosis

3. are not working currently due to their mental illness

4. are not receiving or in a process of receiving employment services

5. are interested in learning about ways to pursue work in the future

6. are fluent in English.

Exclusion Criteria:

1. co-existing physical or developmental disabilities resulting in cognitive limitations

2. Inability to give full and knowing consent.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Vocational Empowerment Photovoice (VEP)
The VEP program is a 10-week manualized, structured, peer-led intervention delivered in 2-hour group sessions. The VEP manual includes a Workbook for the clients and a corresponding Leader's Guide for the group peer-leaders. The VEP program integrates Photovoice methodology, Rehabilitation Readiness technology and elements of the Anti-Stigma Photovoice (ASP) curriculum previously developed and tested by the Boston University Center for Psychiatric Rehabilitation (BU CPR). VEP group sessions combine didactic information, Photovoice exercises, and group discussions to empower participants in pursuing employment services and opportunities, all refined with input from individuals with a lived experience.

Locations

Country Name City State
United States Pilgrim Psychiatric Center Brentwood New York
United States Thresholds Inc. Chicago Illinois
United States Baycove Human Services- Transitions of Boston Dorchester Massachusetts

Sponsors (4)

Lead Sponsor Collaborator
Boston University Charles River Campus National Institute on Disability, Independent Living, and Rehabilitation Research, Pilgrim Psychiatric Center, Thresholds Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Engagement in employment and employment services Measured by number of appointments with supported employment providers and days employed during each follow up period. Baseline to 12 months
Primary Work Hope Measured by the Work Hope Scale Baseline to 12 months
Primary Vocational Identity Measured by the Vocational Identity Scale Baseline to 12 months
Primary Work Motivation Measured by the Work Motivation Scale Baseline to 12 months
Secondary Belief in Work Capacity Measured by a single item scale Baseline to 12 months
Secondary Internalized Stigma Measured by the Internalized Stigma of Mental Illness Scale Baseline to 12 months
Secondary Empowerment Measured by Making Decisions Empowerment Scale Baseline to 12 months
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