Mental IllnessVEPNCT02784938
Vocational Empowerment Photovoice (VEP)
A study testing Vocational Empowerment Photovoice (VEP) in people with Mental Illness, run by Boston University Charles River Campus at 3 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mental Illness
- What is being tested?
- Vocational Empowerment Photovoice (VEP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 147 participants
- Where
- 3 sitesUnited States
- Study dates
- 11 Nov 2015to 12 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- are 18 or older
- have a DSM-IV diagnosis of serious mental illness, including dual diagnosis
- are not working currently due to their mental illness
- are not receiving or in a process of receiving employment services
- are interested in learning about ways to pursue work in the future
- are fluent in English.
Who cannot join
- co-existing physical or developmental disabilities resulting in cognitive limitations
- Inability to give full and knowing consent.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Pilgrim Psychiatric Center
Brentwood, New York, 11717
Thresholds Inc.
Chicago, Illinois, 60613
Baycove Human Services- Transitions of Boston
Dorchester, Massachusetts, 02122
About this study
Official title: Randomized Clinical Trial Evaluating the Efficacy of the Peer-run Vocational Empowerment Photovoice (VEP) to Increase the Capacity of Individuals With Psychiatric Disabilities to Pursue Employment
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.
Read the detailed 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.
- Conditions
- Mental Illness
- Being tested
- Vocational Empowerment Photovoice (VEP)
- Keywords
- Employment, Mental Illness, Photovoice
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vocational Empowerment Photovoice (VEP)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Vocational Empowerment Photovoice (VEP) | Experimental | The VEP program is a 10-week manualized, structured, peer-led intervention delivered in 2-hour group sessions. 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. Receives: Behavioral: Vocational Empowerment Photovoice (VEP) |
| Wait-list Control | No intervention | Services as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Engagement in employment and employment services
Measured by number of appointments with supported employment providers and days employed during each follow up period.
Measured: Baseline to 12 months
Work Hope
Measured by the Work Hope Scale
Measured: Baseline to 12 months
Vocational Identity
Measured by the Vocational Identity Scale
Measured: Baseline to 12 months
Work Motivation
Measured by the Work Motivation Scale
Measured: Baseline to 12 months
Secondary outcomes (3)
Belief in Work Capacity
Measured by a single item scale
Measured: Baseline to 12 months
Internalized Stigma
Measured by the Internalized Stigma of Mental Illness Scale
Measured: Baseline to 12 months
Empowerment
Measured by Making Decisions Empowerment Scale
Measured: Baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2016 (estimated)
- Study start11 Nov 2015
- Primary completion12 May 2020
- Study completion12 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University Charles River Campus
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Disability, Independent Living, and Rehabilitation Research, Thresholds Inc., Pilgrim Psychiatric Center
- Responsible party
- Principal investigator, Zlatka Russinova, Boston University Charles River Campus
- Investigators
- Zlatka Russinova, Study director, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02784938
- Sponsor's protocol ID
- 90RT5029-01-00 R3
- Acronym
- VEP
- Status last verified
- Sep 2020
- First submitted
- 20 May 2016
- Last updated
- 17 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial Evaluating the Efficacy of the Peer-run Vocational Empowerment Photovoice (VEP) to Increase the Capacity of Individuals With Psychiatric Disabilities to Pursue Employment
- ClinicalTrials.gov ID
- NCT02784938
- Acronym / sponsor ID
- VEP / 90RT5029-01-00 R3
- Conditions
- Mental Illness
- Keywords
- Employment, Mental Illness, Photovoice
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- Boston University Charles River CampusUniversity, hospital or other
- Collaborators
- National Institute on Disability, Independent Living, and Rehabilitation Research, Thresholds Inc., Pilgrim Psychiatric Center
- Study start
- 11 Nov 2015 (actual)
- Primary completion
- 12 May 2020 (actual)
- Study completion
- 12 May 2020 (actual)
- First posted
- 27 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vocational Empowerment Photovoice (VEP) | Experimental | 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 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. |
| Wait-list Control | No intervention | –Services as usual |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- are 18 or older
- have a DSM-IV diagnosis of serious mental illness, including dual diagnosis
- are not working currently due to their mental illness
- are not receiving or in a process of receiving employment services
- are interested in learning about ways to pursue work in the future
Key exclusion criteria (2 listed)
- co-existing physical or developmental disabilities resulting in cognitive limitations
- Inability to give full and knowing consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Vocational Empowerment Photovoice (VEP) |
Primary outcome
Engagement in employment and employment services
Time frame: Baseline to 12 months
Measured by number of appointments with supported employment providers and days employed during each follow up period.
Work Hope
Time frame: Baseline to 12 months
Measured by the Work Hope Scale
Vocational Identity
Time frame: Baseline to 12 months
Measured by the Vocational Identity Scale
Work Motivation
Time frame: Baseline to 12 months
Measured by the Work Motivation Scale
3 secondary outcomes
Belief in Work Capacity
Time frame: Baseline to 12 months
Internalized Stigma
Time frame: Baseline to 12 months
Empowerment
Time frame: Baseline to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zlatka Russinova study director
Boston University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vocational Empowerment Photovoice (VEP) in people with Mental Illness, run by Boston University Charles River Campus at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Engagement in employment and employment services (time frame: Baseline to 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2020.