Trial Outcomes & Findings for Cognitive Behavior Therapy for Work Success in Veterans With Mental Illness: A Pre-post Efficacy Study (NCT NCT01918774)

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

Competitive employment is standard in studies of employment in persons with mental illness and will include change in the total number of weeks worked in competitive jobs between baseline and the 6 month follow-up point.

Steady competitive work attainment, defined as working at least half the follow up period, will be assessed at the 6 month follow up.

The Work and Health Interview (Stewart et al., 2003) 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?". Higher scores indicate more work effectiveness. The Work and Health Interview has been used widely in patients with chronic conditions, demonstrating good psychometric properties.

The Positive and Negative Syndrome Scale (PANSS) has been used extensively in studies of psychiatric rehabilitation and CBT. The PANSS (Kay et al., 1987) 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). Higher scores indicate more severe symptoms. The PANSS has adequate reliability and validity in adults with severe mental illness (Kay et al., 1987).

Change in levels of depression will be assessed using the Beck Depression Inventory, Second Edition (BDI-II; Beck, Steer, \& Brown, 1996). 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). Total scores range from 0 to 63, with higher scores indicating more severe depressive symptoms. 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 (e.g., Yin \& Fan, 2000).

Symptoms of anxiety will be assessed using the Beck Anxiety Inventory (Beck \& Steer, 1993). 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. Total scores range from 0 to 63 with higher scores indicating more severe anxiety symptoms. The BAI has been widely used to assess anxiety in adults with mental illness and has been demonstrated to have strong psychometric properties (e.g., Fydrich, Dowdall, \& Chambless, 1992).

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 (Waghorn et al., 2005). The 37-item self-report scale yields a total score on a 0 to 100 point scale, in which higher scores indicate stronger self efficacy related to work. Studies suggest that the scale has adequate to good reliability and validity in adults with mental illness living in the community (Harris et al., 2010).

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; Lehman, 1988), 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 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 (Lehman, 1988; Lehman et al., 1993). This study focused on the health quality of life domain, comprised of 6 items scores on a 1 to 7 likert scale. Scores range from 6 to 42 with higher scores indicating higher quality of life.

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; 2). integrated regulation motivation; 3) identified regulation motivation; 4) introjected regulation; 5) external regulation ; 6) amotivation . The WEIMS is scored on a 1 to 7 Likert scale ('Does not correspond at all' to 'Corresponds exactly'). Mean WEIMS scores range from 1 to 7 with higher scores indicating higher levels of motivation. The WEIMS has been shown to have strong predictive validity, correlating highly with work behaviors (e.g., Tremblay et al., 2009).

The Rosenberg self esteem scale, a 10-item Likert scale (1-strongly agree; 2-agree; 3-disagree; 4-strongly disagree) will examine self esteem (Rosenberg, 1965); 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 (e.g. Link et al., 2014). Scores range from 10 to 40, with lower scores indicate higher self esteem.

Global perceived recovery will be assessed by the Recovery Assessment Scale (Corrigan et al., 1999), 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." Total scores range from 41 to 205, with higher scores indicating stronger perceptions of personal recovery. The RAS has shown good test retest reliability, internal consistency, and criterion-related validity (Corrigan et al., 1999).

The Work and Health Interview (Stewart et al., 2003) will assess work productivity for participants who are currently working. Work productivity will be measured by 7 self-report items (e.g., "During the past 2 weeks, how often did you lose concentration at work?") scored on a Likert scale ranging from 0, "none of the time" to 4, "all the time" . Total scores are calculated using the mean of all items and then converted to quarter percentages, yielding a final work productivity score ranging from 0 to 100. Higher scores indicate more disruption and lower work productivity. Lower scores indicate less work disruption and higher work productivity. The Work and Health Interview has been used widely in patients with chronic conditions, demonstrating good psychometric properties.