Posttraumatic Stress DisordersWORKWELLNCT04504903
Cognitive Behavioral Therapy to Improve Work and Wellness in Veterans With Mental Illness
A study testing Cognitive Behavioral Therapy For Work Success (CBTw) and Psychoeducation in people with Posttraumatic Stress Disorders, run by VA Office of Research and Development at 3 sites in United States.
Trial summary
Vocational instability in Veterans with serious mental illness (SMI) is pervasive, costly, and harmful. Over 75% of Veterans with SMI are unemployed, resulting in economic difficulties and trouble meeting basic needs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Posttraumatic Stress Disorders
- What is being tested?
- Cognitive Behavioral Therapy For Work Success (CBTw) and Psychoeducation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 294 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Jan 2021to 30 Sep 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unemployment, defined as no current participation in a competitive job
- A competitive work goal, which denotes a goal of a regular job in the community that pays at least minimum wage
- Presence of a serious mental illness including one or more of the following conditions:
- major depression
- bipolar disorders
- schizophrenia
Show all 9Show fewer
- schizoaffective disorder
- posttraumatic stress disorder (PTSD)
- Currently enrolled in and receiving VA vocational rehabilitation services
Who cannot join
- Previous participation in cognitive behavioral therapy intervention geared toward work
- Presence of a severe medical or cognitive impairment that will prevent participation in the study
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Edward Hines Jr. VA Hospital, Hines, IL
Hines, Illinois, 60141-5000
Richard L. Roudebush VA Medical Center, Indianapolis, IN
Indianapolis, Indiana, 46202-2884
St. Louis VA Medical Center John Cochran Division, St. Louis, MO
St Louis, Missouri, 63106
About this study
Official title: Work as a Determinant of Health: A Pragmatic Trial of Enhanced Cognitive Behavioral Therapy to Bolster Competitive Work and Wellness in Veterans With Serious Mental Illness (WORKWELL)
Vocational instability in Veterans with serious mental illness (SMI) is pervasive, costly, and harmful. Over 75% of Veterans with SMI are unemployed, resulting in economic difficulties and trouble meeting basic needs. Overall, among adults with depression, work dysfunction results in a 36 to 51 billion dollar loss annually. Unemployed Veterans with SMI also suffer major health consequences, including a more severe course of illness and poor recovery over time, leading to increased inpatient and emergency service use. The WORKWELL study will synergistically address these deficits in health, recovery, and work functioning by testing the Cognitive Behavioral Therapy for Work Success (CBTw) intervention. Using a pragmatic design, this project will address work as a major social determinant of health and close the health disparity gap among people with SMI. Further, through promotion of work and healthy thinking, CBTw holds promise to reduce risk of suicide among vulnerable veterans with SMI.
Read the detailed description
Project background: Work is a major social determinant of health. In people with serious mental illness (SMI), work is associated with better wellbeing, physical and mental health, quality of life, and may prevent the onset of disability. Among Veterans with SMI, work is a protective factor against suicide.
Most veterans with SMI are unemployed and suffer substantially worse health and recovery across key domains. Despite quality VHA vocational services, such as supported employment (SE), two-thirds or more of Veterans who receive these services experience work dysfunction. A probable explanation lies in unsolved cognitive and behavioral barriers, such as low work-related self-efficacy, ineffective coping skills, little hope that work is attainable, poor work motivation and sense of self.
The Cognitive Behavioral Therapy for Work Success (CBTw) intervention was designed to target these problems and augment VHA SE services to synergistically improve work, as well as health and recovery, in Veterans with SMI. In an open trial pilot, CBTw was associated with significant increases in hours worked and wages earned and the majority of CBTw participants became steady workers. Veterans also experienced improvements in symptoms, recovery, and quality of life.
Project goals: Using Hybrid 1 RCT design, this project will test the effects of CBTw on competitive work and health and recovery outcomes over a 12-month study period at 3 VA SE programs. Informed by the RE-AIM framework, an implementation evaluation will examine the success of using SE staff to deliver CBTw, barriers and facilitators to implementation, and strategies utilized.
Relevance to priorities: This project has high implementation potential and is responsive to the VHA priority regarding Health Equity, as it will address work functioning, an under studied social determinant of health. WORKWELL also holds promise to improve health and recovery outcomes among Veterans with SMI, another HSR\&D area of emphasis. Lastly, this study is consistent with the goal of finding novel strategies toward suicide prevention among vulnerable Veteran groups, including those with SMI.
Objectives: Aim 1: Test the effects of CBTw + SE compared to a control of psychoeducation + SE on work. Hypotheses: Participants in the CBTw+ SE arm will work significantly more total weeks in competitive jobs (primary study outcome) and will be more likely to become steady workers.
Aim 2: Test the effects of CBTw + SE on health and recovery. Hypotheses: Participants in the CBTw + SE arm will have greater improvements on subjective recovery and health-related quality of life, and decreases in symptoms, suicidal ideation, and inpatient service utilization.
Aim 3: Guided by the RE-AIM implementation science framework, conduct an evaluation of the implementation of CBTw, including examination of the feasibility of using SE staff to deliver CBTw, and related barriers and facilitators. The objective is to spur future wide scale CBTw implementation.
Project Methods: WORKWELL is a pragmatic, Hybrid 1 design RCT. CBTw will be tested at 3 SE sites-Roudebush VA Medical Center, the Edward J. Hines VA Medical Center, and the VA St. Louis Health Care System. 276 unemployed Veterans with SMI will be randomly assigned to receive CBTw plus SE or a control of psychoeducation plus SE. Outcomes including total weeks worked in competitive jobs (primary), achievement of steady work, symptoms, recovery, health related quality of life, suicidal ideation, and service utilization will be assessed at posttreatment (12 weeks), 6 months (primary endpoint), and 9 months (to examine sustained effects). Primary work outcomes will be collected monthly over a 12-month period. CBTw implementation planning, training, and consultation will be provided. CBTw implementation (fidelity), barriers and facilitators to implementation, and other RE-AIM elements will be examined using mixed methods.
- Conditions
- Posttraumatic Stress Disorders
- Being tested
- Cognitive Behavioral Therapy For Work Success (CBTw), Psychoeducation
- Keywords
- Rehabilitation, Vocational
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Therapy For Work Success (CBTw)Behavioural
Veterans will go to 12 weekly group sessions and will learn healthy thinking about work, positive behavioral coping related to work, and will form a work success plan based on their work goals.
PsychoeducationBehavioural
Veterans will go to 12 weekly group sessions and will learn more information about their mental health conditions. Psychoeducation modules are from the Illness Management and Recovery program.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behavioral Therapy For Work Success (CBTw) | Experimental | Veterans will participate in 12 weekly group sessions to discuss thoughts, feelings, and behaviors that promote work success in the community Receives: Behavioral: Cognitive Behavioral Therapy For Work Success (CBTw) |
| Psychoeducation | Active comparator | Veterans in the control group will participate in 12 weekly group sessions in which they will learn more about their mental health conditions. Receives: Behavioral: Psychoeducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Weeks Worked in Competitive Jobs
Mean number of weeks worked in competitive jobs. Competitive jobs are regular jobs open to all that pay at least minimum wage. More total weeks worked in competitive jobs is indicative of a positive outcome.
Measured: Baseline to 3 months
Total Weeks Worked in Competitive Jobs
Mean number of weeks worked in competitive jobs.
Measured: 3 to 6 Months
Total Weeks Worked in Competitive Jobs
Mean number of weeks worked in competitive jobs.
Measured: 6 to 9 months
Secondary outcomes (4)
Short Employment Hope Scale (EHS-14)
The Short Employment Hope Scale (EHS-14) measures employment hope, defined as the psychological construct characterized by possession of work-related empowerment and motivation for the future, envisionment of meaningful and satisfying employment, job-based goal orientation, and progress toward employment using skills and resources. The EHS-14 is comprised of two subscales-Psychological Empowerment and Goal-oriented pathways (7 items each). The EHS-14 is made up of a total of 14 items scored on a 0 (minimum) to 10 (maximum) scale with total scores comprised of a mean of all 14 items. Higher scores indicate better (increased) employment hope and lower scores indicate worse (decreased) employment hope.
Measured: baseline to 9 months
Recovery Assessment Scale (RAS)
The Recovery Assessment Scale (RAS) measures subjective mental health recovery. The RAS consists of 41 items and an overall score is calculated using a mean of all items, with scores ranging from 1 (maximum) to 5 (minimum). Higher RAS scores indicate better (increased) subjective recovery with lower RAS scores indicating worse (decreased) subjective recovery. This outcome was only examined for patient participants and not for provider participants arm.
Measured: baseline to 9 months
Scale for Suicidal Ideation Change
Outcome measure is a 21-item interviewer rated measure of a continuum of suicidal ideation, including thoughts, attitudes, plans, and behaviors. Total scores range from 0 to 42 with higher scores indicating more suicidal ideation.
Measured: baseline to 9 months
Cognitive Behavioral Therapy for Work Success (CBTw) Fidelity
Fidelity to the Cognitive Behavioral Therapy for Work Success (CBTw) model was measured using the Cognitive Therapy Scale-Revised. The Cognitive Therapy Scale-Revised is comprised of 8 items gauging core components of the CBTw intervention and overall fidelity is measured as a mean of the 8 items. Total fidelity scores range from 0 (minimum) to 6 (maximum) with higher scores indicating greater adherence and proficiency to the CBTw model. Scores of 3 or higher indicate adequate fidelity in which the CBTw intervention is considered delivered as intended. Fidelity was only measured for provider participants and was not measured for participants in the Cognitive Behavioral Therapy for Work Success and Psychoeducation arms.
Measured: 12 weeks (during the CBTw intervention period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2020
- Study start1 Jan 2021
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
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 Posttraumatic Stress DisordersStudies 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
- Model description
- Unemployed participants with serious mental illness will be randomized to receive group-based cognitive behavioral therapy geared toward improving competitive work outcomes or a time and format matched psychoeducation intervention
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 294 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Marina Elizabeth Kukla, PhD MS BS, Principal investigator, Richard L. Roudebush VA Medical Center, Indianapolis, IN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04504903
- Sponsor's protocol ID
- IIR 19-176
- Acronym
- WORKWELL
- Status last verified
- Mar 2026
- First submitted
- 4 Aug 2020
- Last updated
- 1 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon request, the Research Service will consider requests for the final data sets underlying the publications to be provided to the public. The limited dataset will include de-identified data relevant to the specific request. Independent research groups can view relevant data to evaluate the extent that data sources support conclusions made by authors in published studies as well as observe additional emergent themes and view supplemental details that might not be included in publications.
Publications
Kukla M, McGuire AB, Weber KC, Hatfield J, Henry N, Kulesza E, Rollins AL. An Investigation of Employment Hope as a Key Factor Influencing Perceptions of Subjective Recovery among Adults with Serious Mental Illness Seeking Community Work. Behav Sci (Basel). 2024 Mar 19;14(3):246. doi: 10.3390/bs14030246.
PubMed 38540549Kukla ME, Rollins AL, Weber K, Hatfield J, Wu W, Faith L. A., Carter J. L., Wiesepape C, Connors MJ, Wahle SS, Pashka NJ, McGuire AB. A Pragmatic Randomized Controlled Trial Investigating Work Enhanced Cognitive Behavioral Therapy for People with Serious Mental Illness (WORKWELL): Background, Design, and Baseline Outcomes. Journal of Vocational Rehabilitation. 2025 Nov 1; 63(3):299-311, DOI: 10.1177/10522263251376530
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Work as a Determinant of Health: A Pragmatic Trial of Enhanced Cognitive Behavioral Therapy to Bolster Competitive Work and Wellness in Veterans With Serious Mental Illness (WORKWELL)
- ClinicalTrials.gov ID
- NCT04504903
- Acronym / sponsor ID
- WORKWELL / IIR 19-176
- Conditions
- Posttraumatic Stress Disorders
- Keywords
- Rehabilitation, Vocational
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 294 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 7 Aug 2020 (actual)
- Results
- Posted 1 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Vocational instability in Veterans with serious mental illness (SMI) is pervasive, costly, and harmful. Over 75% of Veterans with SMI are unemployed, resulting in economic difficulties and trouble meeting basic needs. Overall, among adults with depression, work dysfunction results in a 36 to 51 billion dollar loss annually. Unemployed Veterans with SMI also suffer major health consequences, including a more severe course of illness and poor recovery over time, leading to increased inpatient and emergency service use. The WORKWELL study will synergistically address these deficits in health, recovery, and work functioning by testing the Cognitive Behavioral Therapy for Work Success (CBTw) intervention. Using a pragmatic design, this project will address work as a major social determinant of health and close the health disparity gap among people with SMI. Further, through promotion of work and healthy thinking, CBTw holds promise to reduce risk of suicide among vulnerable veterans with SMI.
Detailed description
Project background: Work is a major social determinant of health. In people with serious mental illness (SMI), work is associated with better wellbeing, physical and mental health, quality of life, and may prevent the onset of disability. Among Veterans with SMI, work is a protective factor against suicide.
Most veterans with SMI are unemployed and suffer substantially worse health and recovery across key domains. Despite quality VHA vocational services, such as supported employment (SE), two-thirds or more of Veterans who receive these services experience work dysfunction. A probable explanation lies in unsolved cognitive and behavioral barriers, such as low work-related self-efficacy, ineffective coping skills, little hope that work is attainable, poor work motivation and sense of self.
The Cognitive Behavioral Therapy for Work Success (CBTw) intervention was designed to target these problems and augment VHA SE services to synergistically improve work, as well as health and recovery, in Veterans with SMI. In an open trial pilot, CBTw was associated with significant increases in hours worked and wages earned and the majority of CBTw participants became steady workers. Veterans also experienced improvements in symptoms, recovery, and quality of life.
Project goals: Using Hybrid 1 RCT design, this project will test the effects of CBTw on competitive work and health and recovery outcomes over a 12-month study period at 3 VA SE programs. Informed by the RE-AIM framework, an implementation evaluation will examine the success of using SE staff to deliver CBTw, barriers and facilitators to implementation, and strategies utilized.
Relevance to priorities: This project has high implementation potential and is responsive to the VHA priority regarding Health Equity, as it will address work functioning, an under studied social determinant of health. WORKWELL also holds promise to improve health and recovery outcomes among Veterans with SMI, another HSR\&D area of emphasis. Lastly, this study is consistent with the goal of finding novel strategies toward suicide prevention among vulnerable Veteran groups, including those with SMI.
Objectives: Aim 1: Test the effects of CBTw + SE compared to a control of psychoeducation + SE on work. Hypotheses: Participants in the CBTw+ SE arm will work significantly more total weeks in competitive jobs (primary study outcome) and will be more likely to become steady workers.
Aim 2: Test the effects of CBTw + SE on health and recovery. Hypotheses: Participants in the CBTw + SE arm will have greater improvements on subjective recovery and health-related quality of life, and decreases in symptoms, suicidal ideation, and inpatient service utilization.
Aim 3: Guided by the RE-AIM implementation science framework, conduct an evaluation of the implementation of CBTw, including examination of the feasibility of using SE staff to deliver CBTw, and related barriers and facilitators. The objective is to spur future wide scale CBTw implementation.
Project Methods: WORKWELL is a pragmatic, Hybrid 1 design RCT. CBTw will be tested at 3 SE sites-Roudebush VA Medical Center, the Edward J. Hines VA Medical Center, and the VA St. Louis Health Care System. 276 unemployed Veterans with SMI will be randomly assigned to receive CBTw plus SE or a control of psychoeducation plus SE. Outcomes including total weeks worked in competitive jobs (primary), achievement of steady work, symptoms, recovery, health related quality of life, suicidal ideation, and service utilization will be assessed at posttreatment (12 weeks), 6 months (primary endpoint), and 9 months (to examine sustained effects). Primary work outcomes will be collected monthly over a 12-month period. CBTw implementation planning, training, and consultation will be provided. CBTw implementation (fidelity), barriers and facilitators to implementation, and other RE-AIM elements will be examined using mixed methods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Unemployed participants with serious mental illness will be randomized to receive group-based cognitive behavioral therapy geared toward improving competitive work outcomes or a time and format matched psychoeducation intervention
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioral Therapy For Work Success (CBTw) | Experimental | Behavioral: Cognitive Behavioral Therapy For Work Success (CBTw)Veterans will participate in 12 weekly group sessions to discuss thoughts, feelings, and behaviors that promote work success in the community |
| Psychoeducation | Active comparator | Behavioral: PsychoeducationVeterans in the control group will participate in 12 weekly group sessions in which they will learn more about their mental health conditions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Unemployment, defined as no current participation in a competitive job
- A competitive work goal, which denotes a goal of a regular job in the community that pays at least minimum wage
- Presence of a serious mental illness including one or more of the following conditions:
- Currently enrolled in and receiving VA vocational rehabilitation services
Key exclusion criteria (2 listed)
- Previous participation in cognitive behavioral therapy intervention geared toward work
- Presence of a severe medical or cognitive impairment that will prevent participation in the 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 |
|---|---|---|
| Cognitive Behavioral Therapy For Work Success (CBTw)Veterans will go to 12 weekly group sessions and will learn healthy thinking about work, positive behavioral coping related to work, and will form a work success plan based on their work goals. | Behavioural | Cognitive Behavioral Therapy For Work Success (CBTw) |
| PsychoeducationVeterans will go to 12 weekly group sessions and will learn more information about their mental health conditions. Psychoeducation modules are from the Illness Management and Recovery program. | Behavioural | Psychoeducation |
Primary outcome
Total Weeks Worked in Competitive Jobs
Time frame: Baseline to 3 months
Mean number of weeks worked in competitive jobs. Competitive jobs are regular jobs open to all that pay at least minimum wage. More total weeks worked in competitive jobs is indicative of a positive outcome.
Total Weeks Worked in Competitive Jobs
Time frame: 3 to 6 Months
Mean number of weeks worked in competitive jobs.
Total Weeks Worked in Competitive Jobs
Time frame: 6 to 9 months
Mean number of weeks worked in competitive jobs.
4 secondary outcomes
Short Employment Hope Scale (EHS-14)
Time frame: baseline to 9 months
Recovery Assessment Scale (RAS)
Time frame: baseline to 9 months
Scale for Suicidal Ideation Change
Time frame: baseline to 9 months
Cognitive Behavioral Therapy for Work Success (CBTw) Fidelity
Time frame: 12 weeks (during the CBTw intervention period)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 38540549Kukla M, McGuire AB, Weber KC, Hatfield J, Henry N, Kulesza E, Rollins AL. An Investigation of Employment Hope as a Key Factor Influencing Perceptions of Subjective Recovery among Adults with Serious Mental Illness Seeking Community Work. Behav Sci (Basel). 2024 Mar 19;14(3):246. doi: 10.3390/bs14030246.
- Results publicationKukla ME, Rollins AL, Weber K, Hatfield J, Wu W, Faith L. A., Carter J. L., Wiesepape C, Connors MJ, Wahle SS, Pashka NJ, McGuire AB. A Pragmatic Randomized Controlled Trial Investigating Work Enhanced Cognitive Behavioral Therapy for People with Serious Mental Illness (WORKWELL): Background, Design, and Baseline Outcomes. Journal of Vocational Rehabilitation. 2025 Nov 1; 63(3):299-311, DOI: 10.1177/10522263251376530
- Individual participant dataSharing planned: Yes. Upon request, the Research Service will consider requests for the final data sets underlying the publications to be provided to the public. The limited dataset will include de-identified data relevant to the specific request. Independent research groups can view relevant data to evaluate the extent that data sources support conclusions made by authors in published studies as well as observe additional emergent themes and view supplemental details that might not be included in publications.
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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.
Marina Elizabeth Kukla, PhD MS BS principal investigator
Richard L. Roudebush VA Medical Center, Indianapolis, IN
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy For Work Success (CBTw) and Psychoeducation in people with Posttraumatic Stress Disorders, run by VA Office of Research and Development 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 9 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 1 Apr 2026. 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?
Yes. Results are posted in the registry (first posted 1 Apr 2026). 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?
Total Weeks Worked in Competitive Jobs (time frame: Baseline to 3 months). The study lists 3 primary outcomes in all. 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 NCT04504903, 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 1 Apr 2026.