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

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)

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04504903
Acronym
WORKWELL
Enrollment
294
Registered
2020-08-07
Start date
2021-01-01
Completion date
2024-09-30
Last updated
2026-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Posttraumatic Stress Disorders

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

BEHAVIORALCognitive 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.

BEHAVIORALPsychoeducation

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

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

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

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

MeasureTime frameDescription
Total Weeks Worked in Competitive JobsBaseline to 3 monthsMean 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

MeasureTime frameDescription
Short Employment Hope Scale (EHS-14)baseline to 9 monthsThe 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 monthsThe 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 Changebaseline to 9 monthsOutcome 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) Fidelity12 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

PRINCIPAL_INVESTIGATORMarina Elizabeth Kukla, PhD MS BS

Richard L. Roudebush VA Medical Center, Indianapolis, IN

Baseline characteristics

Characteristic
Age at First Hospitalization32.587209302325 Age in Years
STANDARD_DEVIATION 12.82579907807
Age, Continuous47.455882352941 years
STANDARD_DEVIATION 12.50828919057
Average Hourly Wage18.902083333333 US Dollars
STANDARD_DEVIATION 10.121010853092
Average Hours Worked per Week35.166666666666 Hours
STANDARD_DEVIATION 7.6137833545286
Combat Experience0 Participants
Cross-cutting Symptom Measure - Anger1.7867647058823 units on a scale
STANDARD_DEVIATION 1.2317292164859
Cross-cutting Symptom Measure - Anxiety1.8529411764705 units on a scale
STANDARD_DEVIATION 1.1651769719394
Cross-cutting Symptom Measure - Depression2.0367647058823 units on a scale
STANDARD_DEVIATION 1.1541107735221
Cross-cutting Symptom Measure - Dissociation1.0955882352941 units on a scale
STANDARD_DEVIATION 1.2464983633902
Cross-cutting Symptom Measure - Mania1.0110294117647 units on a scale
STANDARD_DEVIATION 0.9840711201427
Cross-cutting Symptom Measure - Memory1.32 units on a scale
STANDARD_DEVIATION 1.3233445794321
Cross-cutting Symptom Measure - Personality Functioning1.5927272727272 units on a scale
STANDARD_DEVIATION 1.1882721531786
Cross-cutting Symptom Measure - Psychosis0.3690909090909 units on a scale
STANDARD_DEVIATION 0.8245486992281
Cross-cutting Symptom Measure - Repetitive Thoughts and Behaviors1.2389705882352 units on a scale
STANDARD_DEVIATION 1.1352384506654
Cross-cutting Symptom Measure - Sleep Problems2.2352941176470 units on a scale
STANDARD_DEVIATION 1.4668449089553
Cross-cutting Symptom Measure - Somatic Symptoms1.4926470588235 units on a scale
STANDARD_DEVIATION 1.2678142376454
Cross-cutting Symptom Measure - Substance Use0.7254901960784 units on a scale
STANDARD_DEVIATION 0.8538292857977
Cross-cutting Symptom Measure - Suicidal Ideation0.2647058823529 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 Employment63.34375 Weeks
STANDARD_DEVIATION 94.852554295873
Lifetime Psychiatric Hospitalizations2.3659420289855 Psychiatric Hospitalizations
STANDARD_DEVIATION 3.7533208835388
Longest Held Civilian Job99.301470588235 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 Service66.911764705882 Months
STANDARD_DEVIATION 55.299249286744
Months Since Last Psychiatric Hospitalization95.620481927710 Months Since Last Hospitalization
STANDARD_DEVIATION 242.61233996275
Number of Alcoholic Drinks per Week2.0735294117647 Alcoholic Drinks per Week
STANDARD_DEVIATION 7.504697149308
Number of Felony Convictions0.4779411764705 Number of Felony Convictions
STANDARD_DEVIATION 1.3822521170295
Number of Misdemeanors1.6376811594202 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 Scale161.99264705882 units on a scale
STANDARD_DEVIATION 20.346442522258
Recovery Assessment Scale - Confidence and Hope3.8504901960784 score on a scale
STANDARD_DEVIATION 0.6439729616953
Recovery Assessment Scale - Goal and Success Orientation4.25 Score on a scale
STANDARD_DEVIATION 0.6047175104601
Recovery Assessment Scale - Mean3.9361549497847 Score on a scale
STANDARD_DEVIATION 0.4541901172413
Recovery Assessment Scale - No Domination by Symptoms3.0661764705882 Score on a scale
STANDARD_DEVIATION 1.0342448014702
Recovery Assessment Scale - Reliance on Others3.9338235294117 Score on a scale
STANDARD_DEVIATION 0.6953784568543
Recovery Assessment Scale - Willingness to Ask for Help3.9166666666666 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 subscale7.4503676470588 units on a scale
STANDARD_DEVIATION 1.685331556824
Short Employment Hope Scale - Psychological Empowerment subscale7.9093137254902 units on a scale
STANDARD_DEVIATION 1.7336974507224
SSI and/or SSDI Receipt31 Participants
Substance Use History0 Use Illicit Drugs
Time Since Military Separation1268.0955882352 Weeks
STANDARD_DEVIATION 689.89916470588
Total Convictions2.1691176470588 Total Felony and Misdemeanor Convictions
STANDARD_DEVIATION 4.1643196003915
VA Service Connected Disability33.823529411764 Percentage
STANDARD_DEVIATION 38.778742239443
Veterans RAND 12 item Health Survey - Mental Component Summary38.46572 units on a scale
STANDARD_DEVIATION 12.922004636528
Veterans RAND 12 item Health Survey - Physical Component Summary44.286843391234 units on a scale
STANDARD_DEVIATION 12.204819816004
Weeks Enrolled in Vocational Services at Baseline26.375 Weeks
STANDARD_DEVIATION 57.580981621056
Weeks Worked 6 Months Prior to Baseline4.4926470588235 Weeks
STANDARD_DEVIATION 9.1594891686199

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 1360 / 136
other
Total, other adverse events
2 / 1361 / 136
serious
Total, serious adverse events
0 / 1360 / 136

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 2, 2026