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

Posttraumatic Stress Disorders Clinical Trial

— WORKWELL  

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04504903
• Other study ID #: IIR 19-176
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: September 30, 2024

Study information

• Verified date: October 2023
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 276
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mental Disorders
• Posttraumatic Stress Disorders
• Stress Disorders, Post-Traumatic

Intervention

Behavioral:
• 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.
• Psychoeducation
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.

Locations

Country	Name	City	State
United States	Edward Hines Jr. VA Hospital, Hines, IL	Hines	Illinois
United States	Richard L. Roudebush VA Medical Center, Indianapolis, IN	Indianapolis	Indiana
United States	St. Louis VA Medical Center John Cochran Division, St. Louis, MO	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total weeks worked in competitive jobs change	Outcome measure will be mean number of weeks worked in competitive jobs. The primary endpoint is 6 months (primary comparison will be baseline to 6 months). 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.	baseline to 12 months
Secondary	Achievement of steady competitive work change	Outcome measure of steady competitive work is defined as working at least 50% of the study period as assessed at the 12 month follow up period. Achievement of steady competitive work is a positive outcome.	baseline to 12 months
Secondary	Cross-Cutting Symptom Measure (CCSM) change	Outcome measure is a 23-item, Likert response (scored on a 0 to 4 scale), self-rated instrument that assesses 13 domains of psychiatric symptoms(e.g., depression, anxiety, psychosis, mania, sleep problems, self-harm, substance use, etc.) with higher scores indicating more severe total symptoms. Total scores range from 0 to 92.	baseline to 9 months
Secondary	12-item Short Form Survey (SF-12) change	The SF-12 outcome measure will assess health-related quality of life and is comprised of the Physical Component Summary (PCS) and Mental Component Summary (MCS). Total scores range from 0 to 100 with higher scores indicating higher health-related quality of life.	baseline to 9 months
Secondary	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.	baseline to 9 months
Secondary	Recovery Assessment Scale change	Outcome measure is a 41 item self report survey that will assess subjective recovery attitudes. Total scores range from 41 to 164 with higher scores indicating higher levels of subjective recovery.	baseline to 9 months