Posttraumatic Stress Disorders
Conditions
Keywords
Rehabilitation, Vocational
Brief 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.
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.
Interventions
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.
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.
Sponsors
Study design
Masking description
Research personnel conducting outcomes assessments will be blinded to condition assignment
Intervention 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
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Weeks Worked in Competitive Jobs | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Short Employment Hope Scale (EHS-14) | baseline to 9 months | 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. |
| Recovery Assessment Scale (RAS) | baseline to 9 months | 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. |
| Scale for Suicidal Ideation Change | baseline to 9 months | 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. |
| Cognitive Behavioral Therapy for Work Success (CBTw) Fidelity | 12 weeks (during the CBTw intervention period) | 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. |
Countries
United States
Contacts
Richard L. Roudebush VA Medical Center, Indianapolis, IN
Baseline characteristics
| Characteristic | — |
|---|---|
| Age at First Hospitalization | 32.587209302325 Age in Years STANDARD_DEVIATION 12.82579907807 |
| Age, Continuous | 47.455882352941 years STANDARD_DEVIATION 12.50828919057 |
| Average Hourly Wage | 18.902083333333 US Dollars STANDARD_DEVIATION 10.121010853092 |
| Average Hours Worked per Week | 35.166666666666 Hours STANDARD_DEVIATION 7.6137833545286 |
| Combat Experience | 0 Participants |
| Cross-cutting Symptom Measure - Anger | 1.7867647058823 units on a scale STANDARD_DEVIATION 1.2317292164859 |
| Cross-cutting Symptom Measure - Anxiety | 1.8529411764705 units on a scale STANDARD_DEVIATION 1.1651769719394 |
| Cross-cutting Symptom Measure - Depression | 2.0367647058823 units on a scale STANDARD_DEVIATION 1.1541107735221 |
| Cross-cutting Symptom Measure - Dissociation | 1.0955882352941 units on a scale STANDARD_DEVIATION 1.2464983633902 |
| Cross-cutting Symptom Measure - Mania | 1.0110294117647 units on a scale STANDARD_DEVIATION 0.9840711201427 |
| Cross-cutting Symptom Measure - Memory | 1.32 units on a scale STANDARD_DEVIATION 1.3233445794321 |
| Cross-cutting Symptom Measure - Personality Functioning | 1.5927272727272 units on a scale STANDARD_DEVIATION 1.1882721531786 |
| Cross-cutting Symptom Measure - Psychosis | 0.3690909090909 units on a scale STANDARD_DEVIATION 0.8245486992281 |
| Cross-cutting Symptom Measure - Repetitive Thoughts and Behaviors | 1.2389705882352 units on a scale STANDARD_DEVIATION 1.1352384506654 |
| Cross-cutting Symptom Measure - Sleep Problems | 2.2352941176470 units on a scale STANDARD_DEVIATION 1.4668449089553 |
| Cross-cutting Symptom Measure - Somatic Symptoms | 1.4926470588235 units on a scale STANDARD_DEVIATION 1.2678142376454 |
| Cross-cutting Symptom Measure - Substance Use | 0.7254901960784 units on a scale STANDARD_DEVIATION 0.8538292857977 |
| Cross-cutting Symptom Measure - Suicidal Ideation | 0.2647058823529 units on a scale STANDARD_DEVIATION 0.5992006294518 |
| Diagnosis Bipolar Disorders | 19 Participants |
| Diagnosis Depression | 114 Participants |
| Diagnosis PTSD | 53 Participants |
| Diagnosis Schizophrenia Spectrum Disorder | 7 Participants |
| Education Associates Degree | 18 Participants |
| Education Bachelors Degree | 24 Participants |
| Education High School/GED | 62 Participants |
| Education Masters and Above | 15 Participants |
| Education Some College | 40 Participants |
| Education Technical School or Certification | 8 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 127 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Housing History Group Setting | 19 Participants |
| Housing History Homeless (in Shelter) | 5 Participants |
| Housing History Live Alone | 53 Participants |
| Housing History Live with a Friend | 16 Participants |
| Housing History Live with Family | 31 Participants |
| Housing History Live with Partner/Spouse | 16 Participants |
| Housing History Other | 0 Participants |
| Housing History Supported Housing | 8 Participants |
| Length of Employment | 63.34375 Weeks STANDARD_DEVIATION 94.852554295873 |
| Lifetime Psychiatric Hospitalizations | 2.3659420289855 Psychiatric Hospitalizations STANDARD_DEVIATION 3.7533208835388 |
| Longest Held Civilian Job | 99.301470588235 Months STANDARD_DEVIATION 103.40186400303 |
| Martial Status Married | 23 Participants |
| Martial Status Not Married | 93 Participants |
| Martial Status Separated | 32 Participants |
| Martial Status Widowed/Widower | 4 Participants |
| Military Branch Air Force | 36 Participants |
| Military Branch Army | 66 Participants |
| Military Branch Marines | 25 Participants |
| Military Branch Navy | 26 Participants |
| Military Branch other (not identified) | 1 Participants |
| Months of Military Service | 66.911764705882 Months STANDARD_DEVIATION 55.299249286744 |
| Months Since Last Psychiatric Hospitalization | 95.620481927710 Months Since Last Hospitalization STANDARD_DEVIATION 242.61233996275 |
| Number of Alcoholic Drinks per Week | 2.0735294117647 Alcoholic Drinks per Week STANDARD_DEVIATION 7.504697149308 |
| Number of Felony Convictions | 0.4779411764705 Number of Felony Convictions STANDARD_DEVIATION 1.3822521170295 |
| Number of Misdemeanors | 1.6376811594202 Number of Misdemeanors STANDARD_DEVIATION 4.1348928164373 |
| Race (NIH/OMB) American Indian or Alaska Native | 5 Participants |
| Race (NIH/OMB) Asian | 4 Participants |
| Race (NIH/OMB) Black or African American | 49 Participants |
| Race (NIH/OMB) More than one race | 9 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 72 Participants |
| Recovery Assessment Scale | 161.99264705882 units on a scale STANDARD_DEVIATION 20.346442522258 |
| Recovery Assessment Scale - Confidence and Hope | 3.8504901960784 score on a scale STANDARD_DEVIATION 0.6439729616953 |
| Recovery Assessment Scale - Goal and Success Orientation | 4.25 Score on a scale STANDARD_DEVIATION 0.6047175104601 |
| Recovery Assessment Scale - Mean | 3.9361549497847 Score on a scale STANDARD_DEVIATION 0.4541901172413 |
| Recovery Assessment Scale - No Domination by Symptoms | 3.0661764705882 Score on a scale STANDARD_DEVIATION 1.0342448014702 |
| Recovery Assessment Scale - Reliance on Others | 3.9338235294117 Score on a scale STANDARD_DEVIATION 0.6953784568543 |
| Recovery Assessment Scale - Willingness to Ask for Help | 3.9166666666666 Score on a scale STANDARD_DEVIATION 0.8391157407279 |
| Scale for Suicidal Ideation (SSI-21) | 0.2290909090909 units on a scale STANDARD_DEVIATION 0.8251681375386 |
| Sex: Female, Male Female | 25 Participants |
| Sex: Female, Male Male | 213 Participants |
| Short Employment Hope - Goal Oriented Pathways subscale | 7.4503676470588 units on a scale STANDARD_DEVIATION 1.685331556824 |
| Short Employment Hope Scale - Psychological Empowerment subscale | 7.9093137254902 units on a scale STANDARD_DEVIATION 1.7336974507224 |
| SSI and/or SSDI Receipt | 31 Participants |
| Substance Use History | 0 Use Illicit Drugs |
| Time Since Military Separation | 1268.0955882352 Weeks STANDARD_DEVIATION 689.89916470588 |
| Total Convictions | 2.1691176470588 Total Felony and Misdemeanor Convictions STANDARD_DEVIATION 4.1643196003915 |
| VA Service Connected Disability | 33.823529411764 Percentage STANDARD_DEVIATION 38.778742239443 |
| Veterans RAND 12 item Health Survey - Mental Component Summary | 38.46572 units on a scale STANDARD_DEVIATION 12.922004636528 |
| Veterans RAND 12 item Health Survey - Physical Component Summary | 44.286843391234 units on a scale STANDARD_DEVIATION 12.204819816004 |
| Weeks Enrolled in Vocational Services at Baseline | 26.375 Weeks STANDARD_DEVIATION 57.580981621056 |
| Weeks Worked 6 Months Prior to Baseline | 4.4926470588235 Weeks STANDARD_DEVIATION 9.1594891686199 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 136 | 0 / 136 |
| other Total, other adverse events | 2 / 136 | 1 / 136 |
| serious Total, serious adverse events | 0 / 136 | 0 / 136 |