Cognitive Behavior Therapy for Work Success in Veterans With Mental Illness: A Pre-post Efficacy Study

Background and Significance In 2010, 11.5% of all Gulf War-II Veterans were unemployed; that
figure rose to 15.2% in January 2011 and continues to grow as the number of Veterans from
recent wars increases. The prevalence of mental illness among Veterans is also notable;
estimates range from 31% to nearly 37% for any psychiatric disorder, and over half of these
Veterans are diagnosed with more than one psychiatric condition. In addition, empirical
evidence suggests that some mental disorders are more prevalent in Veterans than in the
general population. Linking unemployment and mental illness, a recent study found that 65% of
Veterans using VA healthcare were unemployed, and compared to employed Veterans, the
unemployed were more likely to have depression, bipolar disorder, post traumatic stress
disorder (PTSD), schizophrenia, or substance use disorders. Vocational dysfunction was
reported most often in disabled Veterans with schizophrenia, PTSD, and substance use
disorders. Not surprisingly, this study also found that unemployed Veterans had significantly
lower income than employed persons. Similarly, a large study focusing specifically on
Veterans with PTSD concluded that vocational dysfunction is a notable problem among this
group, as they were significantly less likely to be employed after participating in VA work
programs compared with participants without the disorder. Because most individuals with
mental illness desire to work in regular competitive employment, the nationwide problem of
unemployment among Veterans with mental illness is particularly troubling.

The VA is addressing this need by implementing supported employment (SE), a psychiatric
rehabilitation approach that provides individual vocational assistance to Veterans with
mental illness. While the SE model is empirically validated and SE programs have been shown
to achieve partial success in improving employment outcomes, a sizable proportion of
individuals, 40% or more, remain unemployed. A further challenge is job retention; Veterans
with mental illness who obtain jobs frequently struggle to maintain them long-term. Even in
the context of high quality, evidence-based vocational services, most studies show only
modest job retention of a few months, and consequently, frequent job losses and inconsistent
vocational functioning remain a substantial and unsolved problem. In response to this
problem, it has been suggested that interventions focusing on patient-level barriers augment
existing vocational services.

Rationale Cognitive behavioral therapy (CBT) effectively reduces symptoms across a range of
psychiatric conditions; however, its benefit to functioning remains less well understood.
Some studies have evidenced a positive influence of CBT on functional outcomes, whereas
others have not. One possible explanation for these inconsistencies across studies is that
CBT interventions are most often focused on symptoms rather than community functioning. The
few CBT interventions that have been specifically designed to address functioning have shown
promising results. One functional area of critical importance is work-a central goal of most
Veterans with (and without) mental illness. However, work functioning has received little
empirical attention in the CBT domain. Despite research evidence suggesting that maladaptive
thoughts about oneself and expectations about the ability to work interfere with work
success, no CBT programs have been developed specifically targeting vocational themes with
the goal of improving competitive work outcomes. Further, a recent paper outlined needed
avenues of future study in the supported employment domain; Drake and Bond (2011) state that
cognitive strategies may be a fruitful area to develop to help "nonresponder" consumers with
mental illness who struggle with vocational dysfunction despite high quality vocational
assistance. The goal of the current project is to address this gap and the serious problem of
unemployment in Veterans with mental illness by testing a CBT program designed to enhance
competitive work functioning in this population.

Aim 1: Test the preliminary efficacy of the CBTw program on key Veteran employment and
psychosocial outcomes utilizing a pre/post design.

Aim 2: Further assess the feasibility of the program, including recruitment, retention rates,
and program participation rates.

Aim 3: Gauge effect sizes in preparation for a larger randomized controlled trial examining
the effectiveness of the CBT program in routine practice settings

Research Design and Methods This study will pilot test a cognitive behavior therapy (CBT)
intervention for persons with mental illness to target improved competitive employment
outcomes, termed the "CBT for Work Success (CBTw) program"; this CBT intervention will serve
as a compliment to existing supported employment services in the VA. Fifty participants will
take part in the 12 week group-based CBTw program. All participants will receive standard SE
services during the study. The longitudinal design will consist of assessments of competitive
employment outcomes, important psychosocial outcomes, and background and demographic
variables at baseline and at two follow-up periods-immediately following the conclusion of
the CBTw program and six months after the conclusion of the program.

Measures Unless otherwise specified, study measures will be collected at three time points:
baseline, post intervention, 3 month follow up.

Background Characteristics. Collected at baseline only, participant background
characteristics will include sex, age, ethnicity, educational attainment, mental health
diagnosis, marital status, residential status, current work status (employed/unemployed),
work history (i.e., weeks worked during the six months preceding the study; legal history.
The investigators will collect this data through a combination of SE records, patient medical
records (i.e., CPRS), and participant self-report.

Competitive Employment Outcomes. Competitive employment outcomes will be assessed at the two
follow-up time points (after the intervention and 6 month follow-up) through participant
self-report and supported employment records when available. These outcomes are standard in
studies of employment in persons with mental illness and will include employment status
(working/not working), job acquisition rate, total number of job losses, the total and mean
number of weeks worked over the follow-up period, job tenure defined as achievement of steady
competitive work--working at least half the follow up period (6 month follow up only), and
total and mean wages earned across the study and follow-up periods.

Work-related self-efficacy. Work related self-efficacy is defined as one's perceived ability
and confidence to perform work activities. Given that the adapted CBT program will seek to
improve these perceptions, the investigators will measure this construct using the
Work-Related Self-efficacy Scale. The 37-item self-report scale yields a total score and
measures four sub-domains of self-efficacy: general work skills, career planning, job
securing skills, and work-related social skills. Studies suggest that the scale has adequate
to good reliability and validity in adults with mental illness living in the community.

Motivation to work: Motivation to work will be measured by the Work Extrinsic and Intrinsic
Motivation Scale (WEIMS) based on self determination theory; the 18-item WEIMS measures six
empirically grounded domains of motivation, including 1). intrinsic motivation (e.g., "I want
to work for the satisfaction I experience from taking on interesting challenges"); 2).
integrated regulation motivation (e.g., I want to work because it is a fundamental part of
who I am."); 3) identified regulation motivation (e.g., "I want to work to attain a certain
lifestyle"; 4) introjected regulation (e.g., "I want to work because I want to be a winner in
life."); 5) external regulation (e.g., I want to work because it provides me with
security."); 6) amotivation (e.g., "I don't know why I want to work."). The WEIMS is scored
on a 1 to 7 Likert scale ('Does not correspond at all' to 'Corresponds exactly') with higher
scores indicating higher levels of each domain of motivation. The WEIMS has been shown to
have strong predictive validity, correlating highly with work behaviors.

Global motivation to work will be measured with one item: "How motivated are you to work?"
measured on a 1 to 10 Likert scale, 1-'Not at all motivated'; 10-'Extremely motivated'.

Work effectiveness & Work Productivity. The Work and Health Interview will assess work
effectiveness and work productivity for participants who are currently working (unemployed
participants will not complete these measures). Work effectiveness will be measured by one
self-report item-" On days that you worked during the past 4 weeks, how effective were you in
your job on average? Please tell me, on a scale of 0 to 100, where 0% means that you were not
at all effective, and 100% means that you were completely effective, how effective would you
say you have been on your job during the past 4 weeks?" Work productivity will be measured by
7 self-report items scored on a Likert scale ranging from 0, "none of the time" to 4, "all
the time" (item example: "Work more slowly than usual?"). Participants will report on work
productivity over the last two weeks. The Work and Health Interview has been used widely in
patients with chronic conditions, demonstrating good psychometric properties.

Self-esteem: The Rosenberg self esteem scale (RSES), a 10-item Likert scale (1-strongly
agree; 2-agree; 3-disagree; 4-strongly disagree) will examine self esteem; higher scores on
the RSES indicate higher levels of a unidimensional self-esteem construct. The RSES has been
used extensively in samples of persons with and without mental illness and across various
ethnic and cultural groups, demonstrating good reliability and validity.

Quality of Life. Prior studies in the mental health domain have demonstrated that quality of
life improves in response to CBT treatment, therefore, as discussed above with regard to
symptoms, quality of life may be enhanced in response to CBT treatment, regardless of the
impact on work outcomes. The Quality of Life Interview (QOLI), developed specifically for a
psychiatric population, will measure Veteran quality of life. The investigators will use the
17 items that assess subjective quality of life, including global life satisfaction and the
following sub-domains: living situation, daily activities and functioning, family relations,
social relations, legal and safety issues, and health. The QOLI has been shown to have very
good reliability and validity in adult outpatients.

Subjective Recovery: Global perceived recovery will be assessed by the Recovery Assessment
Scale (RAS), a 41 item scale designed to assess perceptions of recovery held by persons with
mental illness. Because perceptions of recovery may be amenable to CBT and have been
associated with key functional outcomes, including employment, it is appropriate to examine
in this study. The self-report RAS is scored on a 1 to 5 Likert scale from 'strongly
disagree' to 'strongly agree' (e.g., "I have a desire to succeed."). The RAS has five factors
including "confidence and hope," "willingness to ask for help", "goal and success
orientation", "reliance on others", and "no domination by symptoms." Higher scores indicate
stronger held perceptions of personal recovery. The RAS has shown good test retest
reliability, internal consistency, and criterion-related validity.

Symptoms. Symptoms are essential to assess in this study, as they are often the primary
beneficiary of CBT intervention, demonstrating moderate to large effect sizes in randomized
trials across numerous psychiatric conditions. Thus, it is possible that symptoms may improve
in response to CBT treatment, regardless of change in employment status.

Psychiatric symptoms often present in schizophrenia-spectrum disorders will be assessed by
the Positive and Negative Syndrome Scale (PANSS), which has been used extensively in studies
of psychiatric rehabilitation and CBT. The PANSS is comprised of 30 items scored on a 1 to 7
Likert scale, in which the total score is obtained by adding up scores on all 30 items (total
scores range from 30 to 240). The PANSS has five subscales identified via factor analytic
studies including the Positive syndrome (6 items), Negative syndrome (8 items), Emotional
discomfort (4 items), Hostility (4 items), and Cognitive (7 items). The PANSS has adequate
reliability and validity.

In addition, the investigators will assess depression and anxiety, two commonly occurring
psychiatric conditions in Veterans; depression and anxiety are linked with vocational
dysfunction and have been demonstrated to respond well to CBT. Current levels of depression
will be assessed using the Beck Depression Inventory, Second Edition. The BDI-II contains 21
items that assess the various mood and bodily symptoms of depression; participants are asked
to respond based on symptoms during the past two weeks. There are four response options for
each item reflecting increasing severity of depression; the total score is obtained by
summing up the scores on each item (0-3). The BDI-II is the gold standard tool to assess
depression in both non-clinical and psychiatric populations and has been shown to have
excellent reliability and validity across several prior studies.

Thirdly, symptoms of anxiety will be assessed using the Beck Anxiety Inventory. The BAI has
21 items, each describing a psychological or physiological symptom of anxiety (e.g.,
"Nervous") that respondents rate on a 0 to 3 Likert Scale ("not at all" to "severely") based
on how much they have been bothered by the symptom within the past week. The BAI has been
widely used to assess anxiety in adults with mental illness and has been demonstrated to have
strong psychometric properties.

Current substance use will be assessed at baseline; this in consideration of the
investigators' previous work demonstrating a link between active substance use and
difficulties obtaining work for Veteran with mental illness receiving SE services. In
addition, substance abuse may hinder participants from benefiting from the CBTw intervention.
The investigators will use the recent substance use section of the Addiction Severity Index
(ASI), which assesses use of a variety of substances in the previous 30 days.

Feasibility Assessment: Feasibility of the CBTw program will be assessed by evaluating the
following recruitment, retention, and participation outcomes during the CBTw pilot and at the
follow-up periods: (1) number of participants who are enrolled in the study, (2) number who
attend 50% or more of group sessions, indicating adequate "exposure" to the program, (4) mean
number of sessions attended; (5) number of participants who complete post-treatment follow-up
assessments, and (6) number of participants who complete 6-month follow-up assessments; 7)
number of participants who dropout of the CBTw program.

Fidelity to cognitive behavioral therapy: Adherence to the CBT model will be assessed by an
adapted form of the Revised Cognitive Therapy Scale (CTS-R). The group therapy version is
comprised of seven items rated on a 0-6 likert scale, with rating of "3" or greater on each
item indicating fully-competent practice compared to the average skilled clinician. Prior
studies using the group therapy version of the CTS-R has found good to excellent interrater
reliability. Furthermore, fidelity will be assessed using audio recordings of three random
sessions per CBTw group and will be conducted by a blinded member of the study team trained
in CBT fidelity by Dr. Kukla.

Analysis Data will be analyzed using the Statistical Package for the Social Sciences (SPSS),
version 20. First, frequency distributions and histograms will be generated to determine the
normality of the sampling distribution and inspect for outliers. If the distribution is
skewed, data transformations and the use of nonparametric tests in primary analyses will be
considered. Secondly, descriptive statistics will be generated to characterize the
demographic and background composition of the sample and levels of outcome variables at
baseline, post-treatment, and three months post-treatment. This mean and standard deviation
information obtained will be used for sample size calculation for a future expanded
randomized trial.

Next, study outcomes will be compared between baseline and the two follow up time points
using a series of dependent groups T-tests. Significance values for t-tests will be set at
p<.025 to account for the effect of inflated alpha due to multiple comparisons. Next, mixed
effects regression models will be conducted including a random effect to account for the
nested nature of the data, (i.e. three measurement points nested within participant). These
models will identify of trajectories of change in outcomes over time and will allow for the
inclusion of important covariates (e.g., employment history assessed at baseline). P values
will be set at .05.

Clinical Significance Information from this study will help guide the activities in future
planned studies. Specifically, this will lead to a future larger VA merit study testing the
intervention using a randomized controlled design that is scalable to routine service
settings.

Inclusion Criteria:

- Participants include Veterans who are receiving individualized vocational services at
an urban Midwestern VA medical center.

- Inclusion criteria are a diagnosis of a mental disorder as confirmed through medical
record review, current enrollment in vocational services, and an active goal of
working in the community

- participants may be currently working in the community or unemployed and
searching for work

Exclusion Criteria:

- Exclusion criteria is a major cognitive deficit or severe medical condition that would
prevent participation in the intervention and/or competitive community work.