(Include design, methodology, data collection, techniques, dataanalysis to be employed, evaluation and interpretation methodology for research component)
| Background: Individuals with psychiatric disabilities experience a high rate of exposure to trauma, and the prevalence of Post Traumatic Stress Disorder (PTSD) is estimated to be 28-43%. Nonetheless, PTSD is clearly underdiagnosed and undertreated in this population. In addition, the rehabilitation literature has consistently demonstrated that persons with PTSD have higher rates of unemployment and lower success rates in supported employment programs.
Target population, planned goals & objectives: The high prevalence of PTSD among persons with psychiatric disabilities and its association with poor employment outcomes suggests a clear need to use existing evidence based treatment for PTSD to help persons seeking employment in this population. The purpose of this present study is to evaluate the feasibility and effectiveness of integrated Cognitive Behavioral Treatment for PTSD (I-CBT), a CBT intervention aimed at enhancing employment among the target population of individuals with psychiatric disabilities and comorbid PTSD who are receiving supported employment services.
Innovative strategies utilized: We adapted an evidence based CBT intervention previously proven to be effective for persons with psychiatric disabilities in reducing PTSD symptoms, and integrated it into supported employment. This randomized trial enrolled 130 participants with psychiatric disabilities and comorbid PTSD receiving employment services. Half of them received CBT while the other half received treatment as usual. This is a randomized controlled trial, pre-test/post-test design with repeated measures at baseline, post-treatment and at 12-months post-treatment. We randomized 130 clients with psychiatric disabilities and PTSD. Clients were randomly assigned to Treatment Condition (I-CBT + SE) or Control Condition (SE as usual). Assessment was conducted at baseline, post-treatment, and 12-month follow-ups. Assessments included client interviews, self-reports, and monthly interviews. The following variables were assessed: work-related self-efficacy, alliance with SE job coach, and SE service utilization, employment outcomes, quality of life, PTSD and other psychiatric symptoms, trauma related beliefs about self and the world.
Data Analysis: Careful examination of descriptive statistics and the distributional form of all variables will precede statistical analysis. When necessary, mathematical transformations will be used to normalize continuous data or variables will be recoded to an ordinal or dichotomous scale. The analysis of the results of this study will require many statistical tests of group difference on primary hypotheses and a variety of exploratory analyses.
We expect the sites will differ in some demographic (e.g., more ethnic/racial minorities in the Newark site) and possibly some diagnostic characteristics (e.g., more schizophrenia in some SE programs), but not in the primary outcome measures (e.g., CAPS, employment). If analyses indicate significant site difference in these measures, tests of the primary hypotheses will include site as a covariate.
a. Group Equivalence at Baseline. We will evaluate whether the two groups differ on baseline measures of demographic and background factors, key outcome variables, and important covariates using 2 tests, t-tests.
b. Primary Outcome Analyses. Three hypotheses are identified as primary.
Primary Hypothesis #1: Clients participating in I-CBT and SE services will have greater rates of employment, hours worked and wages earned than those participating in SE services alone.
For the criterion measure for employment outcome which is a dichotomous variable of whether or not employed in either a part-time or full-time competitive job during the six month and twelve month intervals, the statistical procedures for the analysis of longitudinal categorical data (e.g., PROC GLIMMIX in SAS) will be used for PTSD diagnosis (a dichotomous outcome). With the continuous variables such as wages earned during the six month and twelve month intervals and , hours worked during the six month and twelve month intervals, t-tests and ANCOVAs will be used to examine the simple treatment effects at each post-treatment assessment point.
Primary Hypothesis #2: Clients participating in I-CBT and SE will have greater engagement in SE services than those participating in SE services alone. The number of no shows within the past 6 months for appointments will be considered as engagement in SE services. t-tests and ANCOVAs will be used to examine the simple treatment effects at each post-treatment assessment point.
Primary Hypothesis #3: Clients participating in I-CBT and SE will report greater self-efficacy toward employment than those participating in SE services alone. t-tests and ANCOVAs will be used to examine the simple treatment effects at each post-treatment assessment point.
Exploratory Hypothesis #1: Clients in the I-CBT and SE services will be more effective in correcting trauma-related beliefs about self and the world than those receiving SE services alone. To test this hypothesis, we will use the summary score from the PTCI Total score. For the PTCI we expect the equivalent groups at baseline to diverge over time and to be statistically different at the post-treatment assessment points. Following endpoint, t-tests and ANCOVAs will be used to examine the simple treatment effects at each post-treatment assessment point,
Exploratory Hypothesis #2: Clients in the I-CBT and SE services will experience decreasing PTSD symptoms from before treatment to the post-treatment and follow-up assessments compared to those receiving SE services alone. Two variables from the CAPS will be used, overall severity of PTSD symptoms and the presence/absence of PTSD diagnosis. Similar procedures will be used as for Exploratory Hypothesis #1, except that statistical procedures for the analysis of longitudinal categorical data (e.g., PROC GLIMMIX in SAS) will be used for PTSD diagnosis (a dichotomous outcome).
Project outcomes: Persons with psychiatric disabilities and PTSD are an underserved and vulnerable population. PTSD in this population is often undiagnosed and treated. This study will provide preliminary data on the effectiveness of the integrated program of CBT and supported employment in addressing PTSD as a hidden barrier to employment for these individuals.