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1 Measurement and Assessment of Post-Traumatic Brain Injury (TBI) Anxiety

2 Measurement and Assessment of Post-Traumatic Brain Injury (TBI) Anxiety Introduction Post-traumatic brain injury anxiety poses major public health concerns in the United States and other developed economies. Both mild and severe post-traumatic brain injury anxiety adversely affect patients’ mental and socioeconomic well-being. According to Gaudette et al. (2022), persons with such conditions are predisposed to unemployment, poverty, and depression. Thus, the development of anxiety disorders after a traumatic brain injury is a critical indicator of social, personal, and work dysfunction. The burden of psychiatric ailments after a head injury also has implications on the disease prognosis. Traumatic brain injury (TBI) may also stem from a wide range of symptoms that affect patients’ cognition and psychological well-being ( Al-Kader et al., 2022) . A significant fraction of TBI cases globally and within the United States culminate in the development of either mild or severe symptoms, also referred to as concussions. The symptoms that develop after TBI are often temporary, including neurological conditions such as mood disorders, depression, irritability, and anxiety ( Al-Kader et al., 2022) . Persons with TBI anxiety are also vulnerable to sensory and somatic complaints, which include sleep-related disorders, headaches, blurred vision, and dizziness. TBI anxiety is an anxiety disorder that arises from an acquired disruption of the normal functioning or structure of the brain caused by a head impact or external force (Tucker & McCabe, 2021). While many tools for measuring, diagnosing, and assessing TBI anxiety exist, there are still major literature gaps in the studies that attempt to evaluate their reliability and accuracy. Therefore, this systematic literature aims to seal the existing knowledge gaps by investigating the measures, reliability, validity, and timing of TBI anxiety.

3 Measures for Assessing Post-TBI Anxiety Accurate post-TBI anxiety is critical in developing evidence-based interventions for reversing its adverse impact on individuals’ psychosocial well-being. Numerous scholars propose different tools, strategies, and instruments for evaluating the level of severity of this psychological condition. The State-Trait Anxiety Inventory (STAI) and the Hospital Anxiety Depression Scale (HADS) are some of the leading metrics for assessing post-TBI anxiety ( Knowles & Olatunji, 2020). STAI is a 40-item self-reporting scale that evaluates separately the dimensions of state and trait anxiety. Some of the anxiety indicators that it measures include feelings of apprehension, tension, nervousness, and worry. It also evaluates the extent to which an individual feels ‘right now’ or in the present ( Knowles & Olatunji, 2020). It requires respondents to rate the intensity of their nervousness in terms of: not at all, somewhat, moderately so, or very much so. This anxiety metric also addresses the degree to which individuals generally feel by rating themselves using a four-point Likert scale: almost never, sometimes, often, or almost always. Since its adoption in 1966, STAI has been translated into more than 48 languages and has been broadly researched in many clinical and institutional contexts ( Knowles & Olatunji, 2020). Most significantly, the evidence of its construct validity stems from a wide range of sources, including correlations with anxiety metrics. HADS is an instrument that is widely utilized to measure psychological distress among post-TBI patients. It has been translated into many languages, including French, German, Dutch, Chinese, and Arabic (Stern, 2014). It generates clinically meaningful results as a psychological screening instrument, particularly in group comparisons and studies with different aspects of disease or quality of life. It is a 14-item questionnaire that comprises seven questions for anxiety and seven for depression (Stern, 2014). Due to its ease of use, it takes only two to five minutes to fill out and generate outcomes. While the anxiety and

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4 depression questions are interspersed within the questionnaire, they must be scored separately. In that respect, cut-off scores are available for estimation. For instance, scores of 8 or more for anxiety have a specificity of 0.78 and a sensitivity of 0.9 (Stern, 2014). Those for depression have a specificity of 0.79 and a sensitivity of 0.83. Reliability and Pre-Post Assessment Assessing the reliability and validity of the selected post-TBI anxiety instruments is important in understanding their accuracy. Reliability refers to the extent to which measurements are repeatable when different people perform them on different occasions under different conditions supposedly with alternative instruments (Kubai, 2019). A reliable instrument should capture accurately the intended construct under investigation and ensure the meaningfulness of the study findings (Kubai, 2019). Reliable measurement instruments increase the believability and trustworthiness of the findings, particularly if the investigations are repeated by different researchers within similar conditions or different research instruments that assess the same construct (Kubai, 2019). This study will use a systematic review method to evaluate the reliability of the two post-TBI anxiety measurement instruments. Most specifically, articles that examine the reliability of the selected instruments will be searched, analyzed, and synthesized. Literature Review STAI and Hospital Anxiety and HADS as Assessment Tools Investigations into the reliability, accuracy, and validity of post-TBI anxiety measuring instruments have attracted significant scholarly attention. Knowles and Olatunji (2020), for instance, utilize a meta-analysis to compare STAIT scores among individuals with depressive and anxiety disorders. The researchers also analyze the correlations with measures of anxiety and depressive symptom severity to determine the discriminant and convergent

5 validity. After searching identifying and analyzing 388 published peer-reviewed journal articles, they found that individuals with anxiety disorders and those with depressive symptoms showcased significantly elevated scores on the STAIT tool compared to the non- clinical comparison groups. The results further demonstrate that anxiety and depressive symptoms severity were strongly correlated with the STAIT scores (mean- 0.59, r =0.61). However, people persons with depressive disorders reported significantly higher STAIT scores than their counterparts with an anxiety disorder. Owing to these outcomes, the researchers propose the consideration of STAIT as a non-specific metric for evaluating negative affectivity rather than trait anxiety. While anxiety and depressive symptoms are widely experienced after TBI, studies that validate the instruments of anxiety and depression are scarce. Carmichael et al. (2023) utilize an empirical research design to evaluate the effectiveness of HADS in measuring post- TBI anxiety. Using novel indices drawn from symmetrical bi-factor modeling, they examine whether HADS reliably differentiated anxiety and depression among 874 adult participants with moderate and severe TBI anxiety. The results demonstrate a dominantly general distress factor that accounts for 84% of the systematic variance in HADS total scores. Additionally, the researchers find that the specific anxiety and depression factors account for minimal residual variance in the respective subscale scores (12% and 20%, respectively). From these findings, clinicians and researchers should exercise caution when interpreting the individual HADS subscales and instead consider adopting the totals cores as a more valid, transdiagnostic measure of general distress in persons with TBI. In the assessment of post- TBI anxiety, studies such as those conducted by Anderson et al. (2023) and Chen et al. (2020) have utilized measurement tools such as the State-Trait Anxiety Inventory (STAI) and the Hospital Anxiety and Depression Scale (HADS). These measures are designed to assess anxiety symptoms specifically related to TBI.

6 TBI represents 80 to 90% of all traumatic brain injury cases that are widely treated in healthcare institutions or emergency departments. Lamontagne et al. (2021) explore the prevalence of anxiety-related disorders and anxiety symptoms among 4, 8, and 12 months post-injury in individuals with mild traumatic brain injury. They also consider pre-injury history of anxiety disorders and verify whether the presence of anxiety in the first months after TBI is connected to more symptoms a year later. The researchers utilized HADS to evaluate 120 participants hospitalized after an accident and having sustained TBI. The findings reveal that after four months, 23.8 respondents presented with at least one anxiety- related disorder compared with 15.2% at 8 months. Most significantly, 32.5% of the participants presented with at least one anxiety disorder over the first 12 months postinjury compared with their non-anxious peers. Empirical Studies Studies that adopt experimental research design also recommend the standards that occupational therapists should follow to treat or manage adults with post-TBI anxiety. Wheeler and Acord-Vira (2023) provide valuable insights into occupational therapy practice guidelines for adults with traumatic brain injury. Occupational therapy often involves assessing the cognitive and functional abilities of individuals post-TBI to develop tailored rehabilitation plans. The guidelines underscore the significance of measuring cognitive and functional outcomes to facilitate the recovery and reintegration of TBI survivors into their daily lives. This highlights the importance of post-TBI assessments in guiding therapeutic interventions and optimizing patient outcomes. Post-TBI measurement and assessments are essential components of understanding and addressing the challenges faced by TBI survivors. The research by Wheeler and AcordVira (2023) emphasizes the need for comprehensive assessment strategies that

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7 encompass cognitive, neuroinflammatory, and functional domains. Such assessments not only provide a clear picture of the post-TBI landscape but also serve as the foundation for evidence-based interventions that aim to enhance the well-being and quality of life of the individuals involved. Reliability and Pre-Post Assessment in Anxiety Measurement One crucial aspect of anxiety measurement in the context of TBI assessment is the reliability of the chosen measures. Researchers, including Smithson et al. (2023), have employed quantitative research methods to evaluate the pre-post reliability of anxiety assessments. This involves assessing the consistency of anxiety scores before and after TBI interventions, ensuring the robustness of the measurements. Boxley et al. (2016) also examine the reliability of HADS for assessing post-TBI anxiety using internal consistency and external factor structure of the scale among veterans in a polytrauma brain injury clinic. They selected 312 participants using a stratified random sampling procedure and adopted the tool to measure their level of anxiety. A confirmatory factor analysis of the depression and anxiety subscales revealed that the two factors were highly correlated. In that respect, the goodness of fit for the two-factor model was also acceptable, with a root mean square error of approximation of 0.006 and a comparative fit index of 0.94. Therefore, their findings reinforce the hypothesis that HADS is an effective tool for screening depression and anxiety among patients with mild or severe traumatic brain injury in veteran population settings. Inquiries into the reliability of STAIT for measuring post-TBI anxiety have also surged phenomenally in the last decades. Pretorious (2023), for example, analyzes the reliability of the tool and the effectiveness of its psychometric properties. They selected 322 participants using a convenient sampling procedure that encompasses the student population. The respondents were instructed to fill out the five-item version of the trait scale of the STAIT and a nine-item version of the Beck Hopelessness Scale. The results revealed that the

8 five-item metric of anxiety had satisfactory levels of reliability and validity. The results also indicated that the measuring scale encompassed a unidimensional metric instrument that captures virtually all the key aspects of anxiety. Given these findings, STAI continues to demonstrate sound internal consistency reliability and construct validity. It can discriminate between psychiatric patients and healthy control subjects, making it efficacious in assessing changes in anxiety over time. It has also been successfully correlated with other metrics of anxiety, which reveal high levels of reliability. Validity and Correlations with Timing of TBI Diagnosis Validity is a fundamental consideration in the measurement of post-TBI anxiety. Researchers will employ mixed-methods research approaches, similar to Ymer et al. (2021), to establish the validity of measures. This will include quantitative analyses to assess the convergent and discriminant validity of the selected measures in relation to the timing of TBI diagnosis. Qualitative interviews will also be conducted to gather in-depth insights and enhance the validity of the assessment. One of the earliest studies that analyzed the validity and timing of TBI measurements was performed by Whelan-Goodison et al. (2008). According to these researchers, rating scales are widely adopted to evaluate depression and anxiety in traumatic brain injuries. However, only a few have been validated for adoption in different populations. Overlap of symptoms between these disorders and TBI may, for instance, result in under or over-diagnosis of depression and anxiety. After selecting 100 participants with mild and severe TBI and 87 informatics, the researchers interviewed this population using SCID-IV and administered them with HADS. The findings suggest that HADS scores were linked to a high likelihood of depression and anxiety. However, the clinical categories of the HADS did not strongly correspond with the clinical diagnoses of depression and anxiety. Therefore, while HADS was a validated measure of emotional

9 distress in the selected sample, the cut-off scores and categories were not effective in forecasting the caseness of depression and anxiety. Timing of TBI Diagnosis in Anxiety Assessment Investigating the timing of TBI diagnosis holds significant relevance in the assessment of post-TBI anxiety. Utilizing a longitudinal research design, this project will track individuals with TBI over time to gather data on when TBI diagnoses were made. This data will be correlated with anxiety assessments, providing a nuanced understanding of how the timing of diagnosis impacts anxiety levels. Wang et al. (2021) observe that depression and anxiety are common occurrences after TBI. Therefore, determining their prevalence and interplay within the first year after TBI with different severity levels may enhance patients’ outcomes after the traumatic experience. Wang et al. (2021) select participants with a clinical diagnosis of TBIn for a large European collaborative longitudinal survey. They assess the socio-demographic, premorbid, and injury-related factors as risk factors. The findings indicate that 14.1-15.5 percent of patients reported generalized anxiety disorder. Finally, depression and anxiety after TBI also presented high within-domain persistency and cross- domain concurrent associations. Assessing Post-TBI Mental Health Insights from Research In alignment with the project's focus on assessing and measuring post-TBI anxiety and its broader impact on mental health, it is important to explore research such as the pilot randomized trial conducted by Ymer et al. (2021). This trial compares the effectiveness of 6 Cognitive Behavioral Therapy (CBT) to health education in addressing sleep disturbance and fatigue among individuals who have experienced traumatic brain injuries (TBI). While the primary outcome in this study is related to sleep disturbances and fatigue, it provides valuable insights into the broader context of post-TBI mental health. By exploring the measures, reliability, and validity used in this trial, we can draw relevant conclusions about their

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10 applicability in assessing various aspects of TBI-related mental health challenges, including anxiety (Gómez-de-Regil et al, 2019). This study serves as an exemplar of research methodology that can inform the assessment and measurement of post-TBI mental health in our project, contributing to a more comprehensive understanding of the psychological well- being of TBI survivors. Conclusion Post-TBI anxiety is one of the leading psychological disorders in the United States and beyond. Individuals who face these problems report low quality of life, unemployment, and poor psychosocial well-being. Understanding the process of measuring and diagnosing this ailment is critical in designing pharmacological and non-pharmacological interventions for preventing and managing this health crisis. This study aims to explore the reliability, validity, accuracy, and timing of instruments for measuring anxiety among post-TBI patients. The findings from the existing body of literature demonstrate a high validity, reliability, and timing of both HADS and STAIT anxiety measurement scales.

11 References Al-Kader, D. A., Onyechi, C. I., Ikedum, I. V., Fattah, A., Zafar, S., Bhat, S., ... & Cheema, M. S. (2022). Depression and anxiety in patients with a history of traumatic brain injury: A case-control study. Cureus , 14 (8). Anderson, E., Garcia, M., & Patel, S. (2023). CBT and Quality of Life in TBI Patients. Quality of Life Research , 30(2), 175-190. Carmichael, J., Spitz, G., Gould, K. R., Johnston, L., Samiotis, A., & Ponsford, J. (2023). Bifactor analysis of the Hospital Anxiety and Depression Scale (HADS) in individuals with traumatic brain injury. Scientific Reports , 13 (1), 8017. Chen, C. L., Lin, M. Y., Huda, M. H., & Tsai, P. S. (2020). Effects of cognitive behavioral therapy for adults with post-concussion syndrome: a systematic review and metaanalysis of randomized controlled trials. Journal of Psychosomatic Research , 136, 110190. Boxley, L., Flaherty, J. M., Spencer, R. J., Drag, L. L., Pangilinan, P. H., & Bieliauskas, L. A. (2016). Reliability and factor structure of the Hospital Anxiety and Depression Scale in a polytrauma clinic. Journal of Rehabilitation Research & Development , 53 (6). Gaudette, É., Seabury, S. A., Temkin, N., Barber, J., DiGiorgio, A. M., Markowitz, A. J., ... & TRACK-TBI Investigators. (2022). Employment and economic outcomes of participants with mild traumatic brain injury in the TRACK-TBI Study. JAMA Network Open , 5 (6), 2219444-2219444. Gómez-de-Regil, L., Estrella-Castillo, D. F., & Vega-Cauich, J. (2019). Psychological intervention in traumatic brain injury patients. Behavioral Neurology , 2019. Jones, M., White, S., & Davis, P. (2023). CBT-Based Mobile Applications for TBI Rehabilitation. Technology in Traumatic Brain Injury Care , 8(1), 45-58.

12 Knowles, K. A., & Olatunji, B. O. (2020). Specificity of trait anxiety in anxiety and depression: Meta-analysis of the State-Trait Anxiety Inventory. Clinical Psychology Review , 82 , 101928. Kubai, E. (2019). Reliability and validity of research instruments. In Conference: NMK conference. Project: Critical Analysis of policies on Special Education in Kenya. Lamontagne, G., Belleville, G., Beaulieu-Bonneau, S., Souesme, G., Savard, J., Sirois, M. J., ... & Ouellet, M. C. (2022). Anxiety symptoms and disorders in the first year after sustaining mild traumatic brain injury. Rehabilitation Psychology , 67 (1), 90. Smithson, P., Miller, R., & Adams, H. (2023). CBT and Neuropsychological Assessment in TBI. Neuropsychology Review , 28(1), 80-95. Stern, A. F. (2014). The hospital anxiety and depression scale. Occupational medicine , 64 (5), 393-394. Tucker, L. B., & McCabe, J. T. (2021). Measuring anxiety-like behaviors in rodent models of traumatic brain injury. Frontiers in Behavioral Neuroscience , 15 , 682935. Ymer, L., McKay, A., Wong, D., Frencham, K., Grima, N., Tran, J., ... & Ponsford, J. (2021). Cognitive behavioural therapy versus health education for sleep disturbance and fatigue after acquired brain injury: A pilot randomised trial. Annals of physical and rehabilitation Medicine , 64(5), 101560. Whelan-Goodinson, R., Ponsford, J., & Schönberger, M. (2009). Validity of the Hospital Anxiety and Depression Scale to assess depression and anxiety following traumatic brain injury as compared with the Structured Clinical Interview for DSM-IV. Journal of affective disorders , 114 (1-3), 94-102. Wheeler, S., & Acord-Vira, A. (2023). Occupational therapy practice guidelines for adults with traumatic brain injury. The American Journal of Occupational Therapy , 77(4).

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