Mental DisorderNCT02400736
Supported Employment in Patient Aligned Care Teams
A study testing Individual Placement and Support (IPS) and Treatment as Usual Vocational Rehabilitation/Transitional Work (TUA-VR) in people with Mental Disorder and Substance Use Disorders, run by VA Office of Research and Development at 1 site in United States.
Trial summary
In response to the Rehabilitation Research and Development (RR\&D) Deployment Health Research, this study addresses the delivery of an evidenced-based vocational rehabilitation, specifically Individual Placement and Support (IPS), for Veterans who are facing unemployment and mental illness as they try to recovery and… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Mental Disorder, Substance Use Disorders, Posttraumatic Stress Disorder
- What is being tested?
- Individual Placement and Support (IPS) and Treatment as Usual Vocational Rehabilitation/Transitional Work (TUA-VR)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Aug 2015to 30 Sep 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 19* (<19 years of age is the state of Alabama defined minor)
- Receiving primary care treatment in the Tuscaloosa VA Medical Center (TVAMC) PACT, called the Transition Center (i.e. served during the OEF/OIF/OND/other Southwest Asia conflicts) or other Primary Care PACT providing care for OEF/OIF/OND/other Southwest Asia Veteran
- Otherwise eligible for TVAMC vocational rehabilitation services, in the event that the Veteran is randomized to TW
- diagnosis that is disabling or potentially disabling (i.e. depressive, bipolar II, anxiety, obsessive-compulsive, trauma- and stressor-related, dissociative, impulse- control, and substance related/addictive (other than caffeine and nicotine) disorder classifications), other than those listed as exclusionary, within past 90 days according to Diagnostic and Statistical Manual 5th edition.
- Currently unemployed, defined as not working in a competitive job for a wage or under-employed, defined as (defined as: working less than 20 hours per week in a job that is low wage and is not in keeping with the Veteran's ability, aptitude, or skills)
- Expression of interest in competitive employment
- Willing and able to give informed consent.
- Note: Veterans with history of mild traumatic brain injury (TBI) may be included in the study.
Who cannot join
- Current diagnosis of (i) schizophrenia, (ii) schizoaffective, (iii) bipolar I disorder, or major depression with psychotic features, since these Veterans may receive IPS in mental health
- Diagnosis of dementia (evidenced in the medical record)
- Clinically significant unstable or severe medical condition, or terminal illness, that would contraindicate study participation or expose them to an undue risk of a significant adverse event
- Unlikely that participant can complete the study, e.g. expected deployment, incarceration, long-term hospitalization, or relocation from the vicinity of the TVAMC during the study period
- Active suicidal or homicidal ideation making it unsafe for Veteran to be included in study
- Current participation in another interventional trial.
Trial locations and contacts
1 site in 1 country.
United States1 site
Tuscaloosa VA Medical Center, Tuscaloosa, AL
Tuscaloosa, Alabama, 35404
About this study
Official title: Efficacy of Supported Employment Within the OIF/OEF Patient Aligned Care Team
In response to the Rehabilitation Research and Development (RR\&D) Deployment Health Research, this study addresses the delivery of an evidenced-based vocational rehabilitation, specifically Individual Placement and Support (IPS), for Veterans who are facing unemployment and mental illness as they try to recovery and re-establish civilian life. This study provides the requisite evidence needed to guide the Veterans Health Administration (VHA) as to whether to expand the target population for IPS to Veterans with any mental disorder, delivered directly within the primary care setting (i.e. Patient Aligned Care Team; PACT). Such modifications in VHA practice could substantially improve Veteran vocational rehabilitation access and outcomes, moving a significantly greater number of disabled Veterans back to full and productive lives in the community.
Read the detailed description
Background: Veterans returning from Iraq and Afghanistan wars often confront unemployment as they reintegrate into civilian life. Over the past two decades, studies of Individual Placement and Support (IPS) supported employment have yielded remarkably robust and consistent vocational rehabilitation outcomes. However, IPS has predominantly only been studied in mental health settings and in the seriously mentally ill populations. Access to a mental health setting for recently deployed Veterans is often delayed by months or years, and thus, result in substantial delay of referrals to vocational rehabilitation programs which leave many Veterans vulnerable to continued unemployment and a deteriorating trajectory.
Methods: This single site, prospective, randomized, controlled study evaluated the efficacy of IPS when delivered within primary care Patient Aligned Care Teams (PACT). Participants were U.S. military Veterans who served in the Operation Enduring Freedom, Operation Iraqi Freedom, and Operation New Dawn (OEF/OIF/OND) and/or any other Southwest Asia operations (i.e. since 1990) who were receiving care in a primary care PACT, currently unemployed and diagnosed with any mental disorder other than a serious mental illness. Eligible participants were randomized 1:1 to either IPS or VHA treatment as usual vocational rehabilitation (TAU-VR) which included prevocational counseling, community based supported employment, or most commonly Transitional Work assignment. Compared to TAU-VR (control condition), IPS delivered within a PACT was hypothesized to result in a higher rate of steady workers, as defined by working >/=50% of the weeks in the 12-month follow-up period in a competitive job (primary outcome), more weeks worked in a competitive job, and more income earned.
Significance: In an innovative approach, this study breaks from the diagnostic categorical approach and the mental health treatment setting and evaluates the efficacy of IPS when delivered in a primary care setting, specifically a PACT that serves Veterans who have returned from the Iraq, Afghanistan, and other Southwest Asia conflicts. Making a substantial paradigm shift, this study integrates IPS within a PACT for the first time ever. The research is directly linked to the RR\&D priority areas of improving vocational outcomes and promoting recovery in Veterans.
- Conditions
- Mental Disorder, Substance Use Disorders, Posttraumatic Stress Disorder, Major Depressive Disorder, Anxiety Disorder
- Being tested
- Individual Placement and Support (IPS), Treatment as Usual Vocational Rehabilitation/Transitional Work (TUA-VR)
- Keywords
- Veterans, Patient Aligned Care Team, Primary Care, Mental Disorders, Substance Use Disorders, Posttraumatic Stress disorder, Major Depression, Individual Placement and Support, Supported Employment, Vocational Rehabilitation, Transitional Work, Anxiety Disorders
- Medical subject headings
- Mental Disorders, Substance-Related Disorders, Stress Disorders, Post-Traumatic, Depressive Disorder, Major, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individual Placement and Support (IPS)Behavioural
Also called Supported Employment
Individual Placement and Support (IPS) is the evidenced based model of supported employment.
Treatment as Usual Vocational Rehabilitation/Transitional Work (TUA-VR)Other
Also called Treatment as Usual, Transitional Work
Vocational Rehabilitation Treatment as Usual includes pre-vocational counseling, Community Based Supported Employment, or most commonly Transitional Work assignments (TW).
| Study group | Role | What they receive |
|---|---|---|
| Individual Placement and Support (IPS) | Experimental | Individual Placement and Support (IPS) is supported employment and involves the following domains: 1) competitive employment: IPS assists participants to enter into competitive jobs; 2) eligibility based on client choice, i.e. "zero exclusion"; 3) integration of IPS and treatment team, i.e. the PACT; 4) patient-centered job match for competitive employment; 5) personalized benefits counseling: IPS specialists help Veterans obtain information about their VA, Social Security, Medicaid, and other government entitlements; 6) rapid job search: IPS specialists use a rapid job search, rather than providing lengthy pre-employment assessment, training, counseling; 7) job development: IPS specialists build an employer network based on Veterans' interests; 8) time-unlimited and individualized support: follow-along IPS supports are individualized and continue for as long as needed during the 12-month study. Receives: Behavioral: Individual Placement and Support (IPS) |
| Treatment as Usual Vocational Rehabilitation/Transitional Work (TAU-VR) | Active comparator | Treatment as Usual Vocational Rehabilitation includes pre-vocational counseling, Community Based Supported Employment, or most commonly Transitional Work assignments (TW) which involves 1) time-limited set-aside work experiences: short-term transitional work experiences in a brokered or set-aside work setting; 2) no strict entrance criteria other than general medical clearance; 3) limited integration of TW and clinical Services; 4) not patient-centered: TW jobs are pre-arranged, set-aside jobs are less likely to have a meaningful relationship to the Veterans' preferences; 5) personalized benefits counseling; 6) limited job search: TW specialists provide variable and limited guidance for competitive job search; 7) no job development: TW specialists do not engage in community based job development; 8) time limited: The TW specialist does not provide long-term follow-up after the first job is obtained. Receives: Other: Treatment as Usual Vocational Rehabilitation/Transitional Work (TUA-VR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Steady Worker
Participants were categorized as a steady worker if they held a competitive job for 50% or more of the 12-month follow-up (i.e. 26 or more weeks out of 52 weeks).
Measured: 12 months
Secondary outcomes (7)
Weeks Worked in a Competitive Job
Number of weeks out of 52 week follow-up in which the participant worked at least one hour in a competitive job.
Measured: 12 months
Time to First Competitive Job
The number of weeks from randomization until the participant worked in a competitive job.
Measured: 12 months
Income Earned From Competitive Jobs
For those participants, the income earned from any competitive jobs was added for the 52-week follow-up period.
Measured: 12 months
Symptom Checklist-90-Revised Change From Baseline to Month 12.
Symptom Checklist-90-Revised (SCL-90-R): 90-item self-report survey; assesses nine dimensions. Each item is self-rated for level of discomfort/distress on scale of 0 "not at all" to 4 "extremely" for somatization (range 0 to 48), obsessive-compulsive symptoms (range 0 to 40), interpersonal sensitivity (range 0 to 36), depression (range 0 to 52), anxiety (range 0 to 40), hostility (range 0 to 24), phobic-anxiety (range 0 to 28), paranoid ideation (range 0 to 24), and psychoticism (range 0 to 40). Total score for a dimension is the sum of items and the distress score for each dimension is the sum divided by number of items in that dimension (range = 0 to 4). Global Severity Index is a mean of all items, calculated by dividing the sum of scores by the number of items (range 0 to 4). Higher score indicates greater distress and increase in score over time indicates worse outcome.
Measured: Change from baseline to month 12 (value at 12 months minus value at baseline) is shown below. Additionally, all relevant time points used in the calculation timeframe from baseline to 12 months (baseline, months 4, 6, 8, and 12) included in analysis.
Income Earned From All Sources
All income earned from competitive, transitional work, and other sources over the 12-month follow-up.
Measured: 12 months
Rosenberg Self-Esteem Scale Change From Baseline to 12 Months.
Rosenberg Self-Esteem Scale (RSES) is a 10-item self-report Likert-type questionnaire that asks participants to indicate the degree of their agreement or disagreement with statements about their self-esteem and self-depreciation from 0 = "strongly agree" to 3 = "strongly disagree". The items are summed and the scoring ranges from 0 to 30, with higher scores indicating a higher degree of self-esteem; a positive change in score over time indicates improved self esteem. A score less than 15 may indicate low self esteem.
Measured: Change from baseline to month 12 (value at 12 months minus value at baseline) is shown below. Additionally, all relevant time points used in the calculation timeframe from baseline to 12 months (baseline, months 4, 6, 8, 12) were included in mixed model.
Income Earned From Competitive Jobs in Participants Who Held a Competitive Job
Income earned ($) from competitive jobs over 12 months was compared between groups for all randomized participants who held a competitive job at some point.
Measured: 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 Mar 2015 (estimated)
- Study start3 Aug 2015
- Primary completion30 Sep 2019
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mental DisorderStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Lori L Davis, MD, Principal investigator, Tuscaloosa VA Medical Center, Tuscaloosa, AL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02400736
- Sponsor's protocol ID
- D1489-I
- Status last verified
- Feb 2022
- First submitted
- 10 Mar 2015
- Last updated
- 9 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data will be shared.
Publications
Davis LL, Blansett CM, Mumba MN, MacVicar D, Toscano R, Pilkinton P, Gay W, Bartolucci A. The methods and baseline characteristics of a VA randomized controlled study evaluating supported employment provided in primary care patient aligned care teams. BMC Med Res Methodol. 2020 Feb 17;20(1):33. doi: 10.1186/s12874-020-0919-1.
PubMed 32066380Davis LL, Mumba MN, Toscano R, Pilkinton P, Blansett CM, McCall K, MacVicar D, Bartolucci A. A Randomized Controlled Trial Evaluating the Effectiveness of Supported Employment Integrated in Primary Care. Psychiatr Serv. 2022 Jun;73(6):620-627. doi: 10.1176/appi.ps.202000926. Epub 2021 Sep 15.
PubMed 34521208
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Supported Employment Within the OIF/OEF Patient Aligned Care Team
- ClinicalTrials.gov ID
- NCT02400736
- Acronym / sponsor ID
- D1489-I
- Conditions
- Mental Disorder, Substance Use Disorders, Posttraumatic Stress Disorder, Major Depressive Disorder, Anxiety Disorder
- Keywords
- Veterans, Patient Aligned Care Team, Primary Care, Mental Disorders, Substance Use Disorders, Posttraumatic Stress disorder, Major Depression, Individual Placement and Support
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 3 Aug 2015 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 27 Mar 2015 (estimated)
- Results
- Posted 30 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In response to the Rehabilitation Research and Development (RR\&D) Deployment Health Research, this study addresses the delivery of an evidenced-based vocational rehabilitation, specifically Individual Placement and Support (IPS), for Veterans who are facing unemployment and mental illness as they try to recovery and re-establish civilian life. This study provides the requisite evidence needed to guide the Veterans Health Administration (VHA) as to whether to expand the target population for IPS to Veterans with any mental disorder, delivered directly within the primary care setting (i.e. Patient Aligned Care Team; PACT). Such modifications in VHA practice could substantially improve Veteran vocational rehabilitation access and outcomes, moving a significantly greater number of disabled Veterans back to full and productive lives in the community.
Detailed description
Background: Veterans returning from Iraq and Afghanistan wars often confront unemployment as they reintegrate into civilian life. Over the past two decades, studies of Individual Placement and Support (IPS) supported employment have yielded remarkably robust and consistent vocational rehabilitation outcomes. However, IPS has predominantly only been studied in mental health settings and in the seriously mentally ill populations. Access to a mental health setting for recently deployed Veterans is often delayed by months or years, and thus, result in substantial delay of referrals to vocational rehabilitation programs which leave many Veterans vulnerable to continued unemployment and a deteriorating trajectory.
Methods: This single site, prospective, randomized, controlled study evaluated the efficacy of IPS when delivered within primary care Patient Aligned Care Teams (PACT). Participants were U.S. military Veterans who served in the Operation Enduring Freedom, Operation Iraqi Freedom, and Operation New Dawn (OEF/OIF/OND) and/or any other Southwest Asia operations (i.e. since 1990) who were receiving care in a primary care PACT, currently unemployed and diagnosed with any mental disorder other than a serious mental illness. Eligible participants were randomized 1:1 to either IPS or VHA treatment as usual vocational rehabilitation (TAU-VR) which included prevocational counseling, community based supported employment, or most commonly Transitional Work assignment. Compared to TAU-VR (control condition), IPS delivered within a PACT was hypothesized to result in a higher rate of steady workers, as defined by working >/=50% of the weeks in the 12-month follow-up period in a competitive job (primary outcome), more weeks worked in a competitive job, and more income earned.
Significance: In an innovative approach, this study breaks from the diagnostic categorical approach and the mental health treatment setting and evaluates the efficacy of IPS when delivered in a primary care setting, specifically a PACT that serves Veterans who have returned from the Iraq, Afghanistan, and other Southwest Asia conflicts. Making a substantial paradigm shift, this study integrates IPS within a PACT for the first time ever. The research is directly linked to the RR\&D priority areas of improving vocational outcomes and promoting recovery in Veterans.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individual Placement and Support (IPS) | Experimental | Behavioral: Individual Placement and Support (IPS)Individual Placement and Support (IPS) is supported employment and involves the following domains: 1) competitive employment: IPS assists participants to enter into competitive jobs; 2) eligibility based on client choice, i.e. "zero exclusion"; 3) integration of IPS and treatment team, i.e. the PACT; 4) patient-centered job match for competitive employment; 5) personalized benefits counseling: IPS specialists help Veterans obtain information about their VA, Social Security, Medicaid, and other government entitlements; 6) rapid job search: IPS specialists use a rapid job search, rather than providing lengthy pre-employment assessment, training, counseling; 7) job development: IPS specialists build an employer network based on Veterans' interests; 8) time-unlimited and individualized support: follow-along IPS supports are individualized and continue for as long as needed during the 12-month study. |
| Treatment as Usual Vocational Rehabilitation/Transitional Work (TAU-VR) | Active comparator | Other: Treatment as Usual Vocational Rehabilitation/Transitional Work (TUA-VR)Treatment as Usual Vocational Rehabilitation includes pre-vocational counseling, Community Based Supported Employment, or most commonly Transitional Work assignments (TW) which involves 1) time-limited set-aside work experiences: short-term transitional work experiences in a brokered or set-aside work setting; 2) no strict entrance criteria other than general medical clearance; 3) limited integration of TW and clinical Services; 4) not patient-centered: TW jobs are pre-arranged, set-aside jobs are less likely to have a meaningful relationship to the Veterans' preferences; 5) personalized benefits counseling; 6) limited job search: TW specialists provide variable and limited guidance for competitive job search; 7) no job development: TW specialists do not engage in community based job development; 8) time limited: The TW specialist does not provide long-term follow-up after the first job is obtained. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 19* (<19 years of age is the state of Alabama defined minor)
- Receiving primary care treatment in the Tuscaloosa VA Medical Center (TVAMC) PACT, called the Transition Center (i.e. served during the OEF/OIF/OND/other Southwest Asia conflicts) or other Primary Care PACT providing care for OEF/OIF/OND/other Southwest Asia Veteran
- Otherwise eligible for TVAMC vocational rehabilitation services, in the event that the Veteran is randomized to TW
- diagnosis that is disabling or potentially disabling (i.e. depressive, bipolar II, anxiety, obsessive-compulsive, trauma- and stressor-related, dissociative, impulse- control, and substance related/addictive (other than caffeine and nicotine) disorder classifications), other than those listed as exclusionary, within past 90 days according to Diagnostic and Statistical Manual 5th edition.
- Currently unemployed, defined as not working in a competitive job for a wage or under-employed, defined as (defined as: working less than 20 hours per week in a job that is low wage and is not in keeping with the Veteran's ability, aptitude, or skills)
Key exclusion criteria (6 listed)
- Current diagnosis of (i) schizophrenia, (ii) schizoaffective, (iii) bipolar I disorder, or major depression with psychotic features, since these Veterans may receive IPS in mental health
- Diagnosis of dementia (evidenced in the medical record)
- Clinically significant unstable or severe medical condition, or terminal illness, that would contraindicate study participation or expose them to an undue risk of a significant adverse event
- Unlikely that participant can complete the study, e.g. expected deployment, incarceration, long-term hospitalization, or relocation from the vicinity of the TVAMC during the study period
- Active suicidal or homicidal ideation making it unsafe for Veteran to be included in study
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 |
|---|---|---|
| Individual Placement and Support (IPS)Also: Supported EmploymentIndividual Placement and Support (IPS) is the evidenced based model of supported employment. | Behavioural | Individual Placement and Support (IPS) |
| Treatment as Usual Vocational Rehabilitation/Transitional Work (TUA-VR)Also: Treatment as Usual, Transitional WorkVocational Rehabilitation Treatment as Usual includes pre-vocational counseling, Community Based Supported Employment, or most commonly Transitional Work assignments (TW). | Other | Treatment as Usual Vocational Rehabilitation/Transitional Work (TAU-VR) |
Primary outcome
Steady Worker
Time frame: 12 months
Participants were categorized as a steady worker if they held a competitive job for 50% or more of the 12-month follow-up (i.e. 26 or more weeks out of 52 weeks).
7 secondary outcomes
Weeks Worked in a Competitive Job
Time frame: 12 months
Time to First Competitive Job
Time frame: 12 months
Income Earned From Competitive Jobs
Time frame: 12 months
Symptom Checklist-90-Revised Change From Baseline to Month 12.
Time frame: Change from baseline to month 12 (value at 12 months minus value at baseline) is shown below. Additionally, all relevant time points used in the calculation timeframe from baseline to 12 months (baseline, months 4, 6, 8, and 12) included in analysis.
Income Earned From All Sources
Time frame: 12 months
Rosenberg Self-Esteem Scale Change From Baseline to 12 Months.
Time frame: Change from baseline to month 12 (value at 12 months minus value at baseline) is shown below. Additionally, all relevant time points used in the calculation timeframe from baseline to 12 months (baseline, months 4, 6, 8, 12) were included in mixed model.
Income Earned From Competitive Jobs in Participants Who Held a Competitive Job
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 32066380Davis LL, Blansett CM, Mumba MN, MacVicar D, Toscano R, Pilkinton P, Gay W, Bartolucci A. The methods and baseline characteristics of a VA randomized controlled study evaluating supported employment provided in primary care patient aligned care teams. BMC Med Res Methodol. 2020 Feb 17;20(1):33. doi: 10.1186/s12874-020-0919-1.
- Derived from this study: PubMed 34521208Davis LL, Mumba MN, Toscano R, Pilkinton P, Blansett CM, McCall K, MacVicar D, Bartolucci A. A Randomized Controlled Trial Evaluating the Effectiveness of Supported Employment Integrated in Primary Care. Psychiatr Serv. 2022 Jun;73(6):620-627. doi: 10.1176/appi.ps.202000926. Epub 2021 Sep 15.
- Methods and Baseline paperLink provided by the sponsor.
- Individual participant dataSharing planned: No. No individual participant data will be shared.
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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.
Lori L Davis, MD principal investigator
Tuscaloosa VA Medical Center, Tuscaloosa, AL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individual Placement and Support (IPS) and Treatment as Usual Vocational Rehabilitation/Transitional Work (TUA-VR) in people with Mental Disorder and Substance Use Disorders, run by VA Office of Research and Development at 1 site 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 8 inclusion and 6 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 9 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 30 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Steady Worker (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02400736, which also lists 2 linked publications.
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 9 Mar 2022.