Cognitive Behavioral Therapy to Improve Work and Wellness in Veterans With Mental Illness (WORKWELL)

  • STATUS
    Recruiting
  • End date
    Sep 30, 2024
  • participants needed
    278
  • sponsor
    VA Office of Research and Development
Updated on 25 March 2022
depression
behavior therapy
schizophrenia

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. 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.

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 9-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). 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.

Details
Condition Posttraumatic Stress Disorders
Treatment Psychoeducation, Cognitive Behavioral Therapy For Work Success (CBTw)
Clinical Study IdentifierNCT04504903
SponsorVA Office of Research and Development
Last Modified on25 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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
schizoaffective disorder
posttraumatic stress disorder (PTSD)
Currently enrolled in and receiving VA vocational rehabilitation services

Exclusion Criteria

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note