Mental Disorders Clinical Trial
Official title:
Cognitive Behavioral Therapy to Enhance Competitive Work Outcomes
Verified date | July 2019 |
Source | VA Office of Research and Development |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 57 |
Est. completion date | September 30, 2018 |
Est. primary completion date | July 31, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | Richard L. Roudebush VA Medical Center, Indianapolis, IN | Indianapolis | Indiana |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development |
United States,
Kukla M, McGuire AB, Salyers MP. Barriers and Facilitators Related to Work Success for Veterans in Supported Employment: A Nationwide Provider Survey. Psychiatr Serv. 2016 Apr 1;67(4):412-7. doi: 10.1176/appi.ps.201500108. Epub 2015 Dec 15. — View Citation
Kukla M, McGuire AB, Salyers MP. Rural and urban supported employment programs in the Veterans Health Administration: Comparison of barriers and facilitators to vocational achievement for veterans experiencing mental illnesses. Psychiatr Rehabil J. 2016 Jun;39(2):129-36. doi: 10.1037/prj0000184. Epub 2016 Apr 7. — View Citation
Kukla M, Salyers MP, Strasburger AM, Johnson-Kwochka A, Amador E, Lysaker PH. Work-focused cognitive behavioral therapy to complement vocational services for people with mental illness: Pilot study outcomes across a 6-month posttreatment follow-up. Psychi — View Citation
Kukla M, Strasburger AM, Lysaker PH. A CBT Intervention Targeting Competitive Work Outcomes for Persons With Mental Illness. Psychiatr Serv. 2016 Jun 1;67(6):697. doi: 10.1176/appi.ps.670504. — View Citation
Kukla M, Strasburger AM, Salyers MP, Rattray NA, Lysaker PH. Subjective Experiences of the Benefits and Key Elements of a Cognitive Behavioral Intervention Focused on Community Work Outcomes in Persons With Mental Illness. J Nerv Ment Dis. 2017 Jan;205(1) — View Citation
Kukla M, Strasburger AM, Salyers MP, Rollins AL, Lysaker PH. A Pilot Test of Group Based Cognitive Behavioral Therapy to Augment Vocational Services for Persons With Serious Mental Illness: Feasibility and Competitive Work Outcomes. J Nerv Ment Dis. 2018 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Competitive Employment | 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. | Change from baseline competitive employment to 6 month follow up competitive employment | |
Primary | Number of Participants With Steady Competitive Work Attainment | Steady competitive work attainment, defined as working at least half the follow up period, will be assessed at the 6 month follow up. | 6 month follow up | |
Secondary | Work Effectiveness | 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. | baseline and 12 week follow up scores | |
Secondary | Positive and Negative Syndrome Scale (PANSS) | 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). | baseline, 12 week follow up | |
Secondary | Beck Depression Inventory (BDI-II) | 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). | baseline, post intervention (12 weeks) | |
Secondary | Beck Anxiety Inventory (BAI) | 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). | baseline, 12 week follow up | |
Secondary | Work Related Self-efficacy Scale | 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). | baseline, 12 week follow up | |
Secondary | Quality of Life Interview | 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. | baseline, 12 week follow up | |
Secondary | Work Extrinsic and Intrinsic Motivation Scale | 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). | baseline, 12 week follow up | |
Secondary | Rosenberg Self Esteem Scale | 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. | baseline to 12 week follow up | |
Secondary | Recovery Assessment Scale | 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). | baseline to 12 week follow up | |
Secondary | Work Productivity | 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. | baseline to 12 week follow-up |
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