Last reviewed · How we verify
Cognitive Behavior Therapy for Work Success in Veterans With Mental Illness: A Pre-post Efficacy Study
NA trial testing Cognitive behavior therapy for work success (CBTw) in Mental Disorders in 57 participants. Completed in 30 September 2018.
| Lead sponsor | VA Office of Research and Development |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | health services research |
| Enrollment | 57 |
| Start date | 1 February 2016 |
| Primary completion | 31 July 2018 |
| Estimated completion | 30 September 2018 |
| Sites | 1 location across United States |
VA Office of Research and Development — full company profile →
18 and older, any sex, with Mental Disorders or Mental Health Services. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| Cognitive Behavioral Therapy for Work Success | 13.6 | ± 11.2 |
Steady competitive work attainment, defined as working at least half the follow up period, will be assessed at the 6 month follow up.
| Group | Value | 95% CI |
|---|---|---|
| Cognitive Behavioral Therapy for Work Success | 27 |
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 sco
| Group | Value | 95% CI |
|---|---|---|
| Cognitive Behavioral Therapy for Work Success | 46.9 | ± 47.3 |
| Group | Value | 95% CI |
|---|---|---|
| Cognitive Behavioral Therapy for Work Success | 88.7 | ± 13.2 |
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).
| Group | Value | 95% CI |
|---|---|---|
| Cognitive Behavioral Therapy for Work Success | 57.9 | ± 11.2 |
| Group | Value | 95% CI |
|---|---|---|
| Cognitive Behavioral Therapy for Work Success | 57.3 | ± 15.3 |
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 stand
| Group | Value | 95% CI |
|---|---|---|
| Cognitive Behavioral Therapy for Work Success | 16.6 | ± 10.3 |
| Group | Value | 95% CI |
|---|---|---|
| Cognitive Behavioral Therapy for Work Success | 12.5 | ± 9.7 |
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., Fyd
| Group | Value | 95% CI |
|---|---|---|
| Cognitive Behavioral Therapy for Work Success | 14.1 | ± 10.3 |
| Group | Value | 95% CI |
|---|---|---|
| Cognitive Behavioral Therapy for Work Success | 12.6 | ± 11.8 |
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).
| Group | Value | 95% CI |
|---|---|---|
| Cognitive Behavioral Therapy for Work Success | 78.7 | ± 13.6 |
| Group | Value | 95% CI |
|---|---|---|
| Cognitive Behavioral Therapy for Work Success | 81.0 | ± 13.3 |
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 functi
| Group | Value | 95% CI |
|---|---|---|
| Cognitive Behavioral Therapy for Work Success | 24.0 | ± 4.1 |
| Group | Value | 95% CI |
|---|---|---|
| Cognitive Behavioral Therapy for Work Success | 25.8 | ± 5.1 |
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 b
| Group | Value | 95% CI |
|---|---|---|
| Cognitive Behavioral Therapy for Work Success | 5.7 | ± 0.7 |
| Group | Value | 95% CI |
|---|---|---|
| Cognitive Behavioral Therapy for Work Success | 5.6 | ± 0.8 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Cognitive Behavioral Therapy for Work Success | 21.7 | ± 4.7 |
| Group | Value | 95% CI |
|---|---|---|
| Cognitive Behavioral Therapy for Work Success | 20.1 | ± 5.0 |
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",
| Group | Value | 95% CI |
|---|---|---|
| Cognitive Behavioral Therapy for Work Success | 128.4 | ± 12.0 |
| Group | Value | 95% CI |
|---|---|---|
| Cognitive Behavioral Therapy for Work Success | 133.3 | ± 15.0 |
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 indicat
| Group | Value | 95% CI |
|---|---|---|
| Cognitive Behavioral Therapy for Work Success | 19.6 | ± 12.1 |
| Group | Value | 95% CI |
|---|---|---|
| Cognitive Behavioral Therapy for Work Success | 12.2 | ± 9.7 |
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. Rationale: Cognitive behavioral therapy (CBT) effectively reduces symptoms across a range of psychiatric conditions; however, its benefit to functioning remains less well understood. 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 SE 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 pilot testing the CBT for work success program (CBTw) and assessing key employment outcomes before and after the intervention, and six months after conclusion of the intervention. Specific Aims: 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
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
Currently open trials in the same condition.
Trials by the same sponsor.
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01918774.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing