Healthcare workers in emergency departments (EDs) and intensive care units (ICUs) are highly vulnerable to stress and burnout. Resilience training may mitigate these effects, but most programs are resource intensive and untested. Heart Rate Variability Biofeedback (HRVB) is a brief intervention (30-min introduction and self-practice 10 min twice daily) that shows promise, yet randomized controlled trials are limited. We randomized patient-facing healthcare workers (n = 37) from EDs and ICUs at a large Southwestern medical center to 4 weeks of HRVB or a waitlist (WL) control. After posttreatment assessment, WL participants crossed over to receive HRVB, and both groups were reassessed 4 weeks later. Resilience, stress, depression, and burnout were measured at pretreatment, posttreatment, and follow-up. Consistent with prediction, resilience (CD-RISC-10) increased significantly in the HRVB group relative to WL from pre- to posttreatment (d = .79, p = .003), and gains were maintained at follow-up. Contrary to prediction, reductions in stress, depression, and burnout were not significantly greater in HRVB than WL. Reliable Change Index analysis showed 21% of HRVB participants improved reliably at posttreatment and 24% at follow-up. Findings support HRVB as a feasible, individually delivered intervention to enhance resilience among ED and ICU healthcare providers.
Background:Spinal cord injury (SCI) increases risk for posttraumatic stress disorder (PTSD). This condition often co-occurs with pain, depression, anxiety, and sleep disturbance, reducing quality of life. Despite the clinical impact of these symptoms, early evidence-based psychological interventions have rarely been evaluated during inpatient rehabilitation. Brief Prolonged Exposure (Brief PE) is a 3-session adaptation of Prolonged Exposure designed to prevent or reduce PTSD. Methods:Participants (n = 154, mean age = 50 years, range 18-87; 65% male) with traumatic or nontraumatic SCI were enrolled at a rehabilitation hospital; 148 were randomized to Brief PE (n = 75) or treatment as usual (TAU; n = 73). Brief PE participants received 3 60-minute sessions during their inpatient stay while TAU participants received standard psychosocial care. The primary outcome was PTSD symptom severity (PSSI-5) at baseline, 1, 3, and 6 months. Secondary outcomes included PTSD diagnosis/severity (PSSI-5/PDS-5), pain (NRS-11), depression (PHQ-9), anxiety (GAD-7), sleep disturbance (PROMIS-SD), resilience (CD-RISC-10), and quality of life (SCI-QOL). Results:PTSD symptoms declined significantly in both groups (P = .003), with no Group × Time effect (P = .33). History of premorbid depression predicted higher PTSD severity (IRR = 1.84, P = .002). At 6 months, PTSD prevalence was lower in Brief PE (5.9%) versus TAU (9.3%), though nonsignificant. Significant Group × Time effects for average and usual pain (P = .032; P = .036) favored Brief PE, with 27% and 33% reductions versus 0% and 5% for TAU. Among Brief PE participants, 96% completed all sessions, with high satisfaction. Conclusion:Brief PE was feasible, acceptable, and produced greater pain reduction than TAU. PTSD symptoms were also lower, though not significantly, suggesting promise for early psychological intervention after SCI.
Decades of research have demonstrated that recovery from serious neurological injury will require synergistic therapeutic approaches. Rewiring spared neural circuits after injury is a long-standing goal of neurorehabilitation1,2. We hypothesized that combining intensive, progressive, task-focused training with real-time closed-loop vagus nerve stimulation (CLV) to enhance synaptic plasticity3 could increase strength, expand range of motion and improve hand function in people with chronic, incomplete cervical spinal cord injury. Here we report the results from a prospective, double-blinded, sham-controlled, randomized study combining gamified physical therapy using force and motion sensors to deliver sham or active CLV (ClinicalTrials.gov identifier NCT04288245). After 12 weeks of therapy composed of a miniaturized implant selectively activating the vagus nerve on successful movements, 19 people exhibited a significant beneficial effect on arm and hand strength and the ability to perform activities of daily living. CLV represents a promising therapeutic avenue for people with chronic, incomplete cervical spinal cord injury.
Vagus nerve stimulation (VNS) is widely used to treat various neurological and psychiatric conditions, including epilepsy and treatment-resistant depression, as well as to enhance motor rehabilitation following stroke. Conventional VNS devices have demonstrated reliability over decades of use, though recent advancements in technology offer new opportunities to further enhance the device. Many emerging indications require only intermittent stimulation, allowing for the development of a miniature externally powered implantable stimulator (MEPS) that is approximately 50 times smaller than conventional devices, is implanted with a single incision, has no battery or leads, and enables paired stimulation. Our observations compiled from three clinical trials with the MEPS device tested the hypotheses that removing the implanted battery and reducing device size would (1) shorten the surgical procedure and (2) maintain or improve safety outcomes. Data were collected from individuals with stroke, spinal cord injury, or post-traumatic stress disorder. Operative time was significantly reduced, averaging 38 ± 1 min compared to 76 ± 3 min for conventional VNS, with no significant intraoperative complications and no revision surgeries. The MEPS device successfully delivered 481,995 stimulations during 2205 h of therapy. One participant underwent an MRI outside the study, indicating compatibility with standard imaging protocols. Device-related adverse events occurred at a low rate; all were mild and resolved before study end. Overall, the MEPS device demonstrated a favorable safety and performance profile in a select population, with fewer occurrences of certain adverse events, extending the strong safety record of conventional VNS systems.
BACKGROUND:Posttraumatic stress disorder (PTSD) is common and debilitating, and many individuals do not respond to existing therapies. We developed a fundamentally novel neuromodulation-based therapy for treatment-resistant PTSD. This approach is premised on coupling prolonged exposure therapy, a first-line evidence-based cognitive behavioral therapy that directs changes within fear networks, with concurrent delivery of short bursts of vagus nerve stimulation (VNS), which enhance synaptic plasticity. METHODS:We performed a first-in-human prospective open-label early feasibility study (EFS) using a next-generation miniaturized system to deliver VNS therapy in nine individuals with moderate to severe treatment-resistant PTSD. All individuals received a standard 12-session course of prolonged exposure therapy combined with VNS. Assessments were performed before, 1 week after, and 1, 3, and 6 months after the completion of therapy. CLINICALTRIALS:gov registration: NCT04064762. RESULTS:VNS therapy resulted in significant, clinically-meaningful improvements in multiple metrics of PTSD symptoms and severity compared to baseline (CAPS-5, PCL-5, and HADS all p < 0.001 after therapy). These benefits persisted at 6 months after the cessation of therapy, suggesting lasting improvements. All participants showed loss of PTSD diagnosis after completing treatment. No serious or unexpected device-related adverse events were observed. CONCLUSIONS:These findings provide a demonstration of the safety and feasibility of VNS therapy for PTSD and highlight the potential of this approach. Collectively, these support the validation of VNS therapy for PTSD in a rigorous randomized controlled trial.
Objective: Exposure to a traumatic event is a primary criterion (Criterion A) for meeting Posttraumatic Stress Disorder (PTSD). Using self-report to establish diagnostic criteria in research has become more common, especially with internet-based research. However, some individuals may construe events as traumatic when they do not meet Criterion A. There has yet to be a test of interrater reliability (IRR) from self-report of traumatic events. Method: Three graduate students in clinical psychology and three licensed psychologists rated Criterion A using the life events checklist (LEC), as well as the three modified LEC versions (specification of up to three index traumas; extension of part 2 of the LEC) aimed to increase IRR. One hundred participants completed each of the four versions of the LEC (N = 400). Bootstrapped permutation tests were used to estimate differences in IRR and to generate 95% confidence intervals (CIs). Results: Overall, findings indicated fair-moderate IRR (Fleiss's kappa) ? = 0.428, 95% CI [0.379, 0.477]. The other versions of the LEC (including additional clarifying questions in part 2 of the LEC and/or opportunities to describe up to three traumas) did not meaningfully increase IRR. Conclusions: Findings indicate that relying on self-report from the LEC alone and/or single-rater assessment of open-text trauma descriptions is not recommended for determining whether a traumatic event meets Criterion A. We conclude that it is critical when collecting self-reported PTSD symptoms to provide a clear description of how Criterion A was assessed, initial agreement between raters, and how disagreements were resolved.
Background/Objectives: This study examined the psychometric properties of the Fatigue and Altered Cognition Scale (FACs) among adult COVID-19 survivors and its unique ability to assess symptomology not accounted for by measures of depression and anxiety. Methods: COVID-19 survivors completed an online survey that included the FACs, a measure of brain fog and central fatigue with 20 items rated on a digital–analog scale. Useable data from 559 participants were analyzed to test the two-factor structure of the FACs, test for measurement invariance by sex and device was used to complete the survey (hand-held, computer), and item correlations with symptoms of depression and anxiety were examined. Results: The two-factor structure of the FACs replicated, supporting the separate assessments of brain fog and fatigue, χ2(164) = 1028.363, p < 0.001, CFI = 0.934, TLI = 0.923, RMSEA = 0.097, SRMR = 0.053. The FACs exhibited invariance at the scalar level, indicating item and factor integrity regardless of sex and device type. Using a correlation > 0.70 as a criterion (i.e., indicating more than 50% shared variance between two items), items on the FACs (assessing fatigue and lack of energy) were highly correlated with feeling tired or having little energy on the depression measure. No other items correlated with any anxiety symptom larger than 0.70. Conclusions: The FACs appears to be a psychometrically sound and efficient measure for use with COVID-19 survivors, assessing symptoms of brain fog and central fatigue that are not attributable to symptoms assessed by established measures of depression and anxiety.
Introduction:The COVID-19 pandemic has had a significant impact on mental health, and individuals with certain preexisting morbidities-such as obesity-may have disproportionately experienced pandemic-related stress. We aimed to examine whether being obese or overweight was associated with worse mood and trauma among those infected with COVID-19. Methods:Data were collected as part of a larger longitudinal survey study (n = 591) examining the psychological impact of COVID-19. Complete baseline data for those who reported testing positive from April 2020 through June 2021 were examined. Results and conclusions:Body mass index was correlated with depression (r = 0.13, P < .01) and generalized anxiety disorder (r = 0.10, P = .02), but not with posttraumatic stress disorder (r = 0.06, P = .16). Multivariable analyses revealed that body mass index was no longer a unique predictor, except for those with a body mass index >40 kg/m2, suggesting that other sociodemographic factors, not obesity, were driving mood symptoms for those infected with COVID-19.
Background: Individuals with chronic health conditions (CHCs) have a higher risk for severe SARS-CoV-2 (COVID-19) infection and reported high rates of distress during the pandemic. However, research suggests individual characteristics distinguish those who are more likely to experience clinical levels of distress than others. We examined predicted differences in distress over time between individuals with CHCs who had resilient and non-resilient personality profiles. Methods: A national sample responded to an online survey that included the study measures. Individuals with CHCs (N = 649) provided complete data to an initial survey and a second administered three months later. Cluster analysis of personality traits identified resilient and non-resilient personality profiles. A longitudinal structural equation model tested an a priori model that specified the relationship of a resilient personality prototype to self-reported resilience, coping, depression and anxiety at both measurement occasions. Results: The final model explained 50.2 % of the variance in distress at Time 1 and 76.2 % at Time 2. A resilient personality prototype significantly predicted less distress at Time 1, and at both time points it predicted and operated through self-reported resilience and less disengaged coping to effect lower distress. Limitations: Sampling biases may limit the generalizability of the study, as the study was limited to self-report data provided by those who completed the study measures at both assessments. Conclusions: Individuals with CHCs who are particularly vulnerable to distress may have characteristics that contribute to a lower sense of confidence and rely on ineffective, disengaged coping behaviors that exacerbate their stress.
Purpose/Objective: Individuals with a spinal cord injury (SCI) may experience posttraumatic stress disorder (PTSD) at a higher rate, which is associated with worse psychiatric comorbidity, decreased quality of life, and greater disability. Yet, effective PTSD interventions remain understudied for individuals with SCI. We conducted the first randomized controlled trial (RCT) of an evidence-based psychotherapy (prolonged exposure [PE]) with survivors of SCI during acute rehabilitation. We examined the efficacy, feasibility, and secondary outcomes. Research Method/Design: Participants (n = 29) were adults recruited from 2018 to 2021 1-month postinjury with PTSD randomized into either PE therapy or treatment as usual. The primary outcome was PTSD assessed at baseline, 6, 10, and 32 weeks postenrollment. Results: An overall group-by-time interaction was not statistically significant (p = .102), but effect sizes demonstrated moderate and large improvements in PTSD for the PE group at 6 (-19.4 vs. -9.7) and 10 (-25.8 vs. -5.7), respectively. Similarly, moderate to large effect sizes were observed for depression, maladaptive posttraumatic cognitions, disruptive nocturnal behaviors, SCI-related quality of life, and risky alcohol consumption. Low rates of enrollment (50%) and treatment completion (25%) suggest feasibility challenges; however, treatment completers did report high satisfaction (100%). Conclusions/Implications: Results suggest that individuals who received PE had a quicker and clinically meaningful reduction in PTSD symptoms, but delivery during acute rehabilitation is not feasible for many individuals. Future research should examine abbreviated versions of PE for PTSD to enhance the feasibility of treatment in this setting.
Background:Caregivers to intensive care unit survivors are vulnerable to caregiver burden, which has been demonstrated to have consequences to patients' and caregivers' mental and physical health. Potentially modifiable factors should be explored so that interventions may be developed. Methods:Ninety-one anticipated caregivers were prospectively assessed both at a southwestern trauma intensive care unit during their patient's admission and at home via remote interview 3 months after intensive care unit admission. Caregiver depression, posttraumatic stress symptoms, experiences, and perceived burden were assessed. Results:At follow up, there was a significant negative correlation between caregiver burden and understanding of their patient's condition (P < 0.001) and intensive care unit events (P = 0.008). Caregivers with lower understanding of their patient's injury/illness had significantly greater depressive symptoms (P = 0.04). Conclusions:Education and knowledge of intensive care unit events regarding their patient may influence perceived burden among caregivers. Interventions to orient caregivers to intensive care unit events are suggested to reduce caregiver and healthcare system burden.
Anxiety sensitivity is a fear of symptoms associated with anxiety (eg, rapid respiration and heart rate, perspiration), also known as "fear of fear." This fear is a misinterpretation of nonthreatening symptoms as threatening across 3 domains: physical ("When my heart rate increases, I'm afraid I may have a heart attack"), social ("If people see me perspire, I fear they will negatively evaluate me"), and cognitive ("When I feel these symptoms, I fear it means I'm going crazy or will lose control and do something dangerous like disconnect my IV"). These thoughts stimulate the sympathetic nervous system, resulting in stronger sensations and further catastrophic misinterpretations, which may spiral into a panic attack. Strategies to address anxiety sensitivity include pharmacologic and nonpharmacologic interventions. In intensive care unit settings, anxiety sensitivity may be related to common monitoring and interventional procedures (eg, oxygen therapy, repositioning, use of urine collection systems). Anxiety sensitivity can be a barrier to weaning from mechanical ventilation when patients are uncomfortable following instructions to perform awakening or breathing trials. Fortunately, anxiety sensitivity is a malleable trait with evidence-based intervention options. However, few health care providers are aware of this psychological construct and available treatment. This article describes the nature of anxiety sensitivity, its potential impact on intensive care, how to assess and interpret scores from validated instruments such as the Anxiety Sensitivity Index, and treatment approaches across the critical care trajectory, including long-term recovery. Implications for critical care practice and future directions are also addressed.
BackgroundChronic pain represents a substantial health burden and source of disability following traumatic injury. This study investigates factors associated with racial and ethnic disparities in chronic pain.MethodsProspective, longitudinal, panel study. Seriously injured patients were recruited from two trauma centres in the Northeastern and Southwestern USA. Data from medical records and individual surveys were collected in-hospital, and at 3-month and 12-month postinjury from a balanced cohort of non-Hispanic black, non-Hispanic white and Hispanic patients. We used linear regression to estimate the associations between race and ethnicity and 3-month and 12-month pain severity outcomes. We grouped all available cohort data on factors that theoretically influence the emergence of chronic pain after injury into five temporally ordered clusters and entered each cluster sequentially into regression models. These included: participant race and ethnicity, other demographic characteristics, preinjury health characteristics, acute injury characteristics and postinjury treatment.Results650 participants enrolled (Hispanic 25.6%; white 38.1%; black 33.4%). Black participants reported highest relative chronic pain severity. Injury-related factors at the time of acute hospitalisation (injury severity, mechanism, baseline pain and length of stay) were most strongly associated with racial and ethnic disparities in chronic pain outcomes. After controlling for all available explanatory factors, a substantial proportion of the racial and ethnic disparities in chronic pain outcomes remained.ConclusionRacial and ethnic disparities in chronic pain outcomes may be most influenced by differences in the characteristics of acute injuries, when compared with demographic characteristics and postacute treatment in the year after hospitalisation.
This chapter reviews cross-sectional, longitudinal, and randomized studies that highlight the interplay between physical activity (PA) and anxiety and its disorders. It summarizes what is known about the PA-anxiety relation with the intent to guide future directions for research in this area. Stress has been implicated in the development and maintenance of anxiety disorders. Research on the effects of acute bouts of PA on anxiety indicates differential effects for aerobic compared to anaerobic (i.e., resistance training) activity. In contrast to findings for acute PA, aerobic and anaerobic training programs appear to yield comparable patterns of anxiety reduction immediately following intervention. Research examining physical inactivity and anxiety sensitivity (AS) has expanded to determine whether other factors, such as body mass index, may play a role in this relationship. In addition to AS, social physique anxiety, described as an individual's anxiety regarding others' evaluation of physical appearance, may influence the relationship between PA and anxiety.
BACKGROUND:As uterus transplantation transitions to a clinical procedure for women with absolute uterine-factor infertility, transplant centers performing uterus transplantation need information about the experience of living donors. This study examined the psychosocial impact on 17 nondirected uterus donors in the Dallas UtErus Transplant Study 1 y following donation.METHODS:A prospective longitudinal study was conducted to measure psychosocial outcomes of depression, anxiety, posttraumatic stress, quality of life, and resilience [measured using the Hospital Anxiety and Depression Scale or Patient Health Questionnaire 9-Item, Generalized Anxiety Disorder 7-Item, Posttraumatic Stress Disorder Checklist for the DSM-5, health-related quality of life Short Form-36, and Connor-Davidson Resilience Scale 10-Item, respectively) assessed at baseline, at 6-mo and 1-y follow-up. Differences among baseline, 6-mo, and 1-y postdonation were analyzed.RESULTS:The median age was 38.0 y, 16 were married, 15 were of non-Hispanic/Latino ethnicity. Most donors did not report psychosocial distress; however, 1 donor reported decline on the role limitations because of Emotional Problems Scale and also showed an increase in depression symptoms at the 6 mo, but at 1 y was below the clinical cutoff for depression. A second donor showed modest decline in emotional well-being. Improvements were seen in other donors on the Physical Functioning Scale and posttraumatic stress symptoms.CONCLUSIONS:Although most nondirected donors appeared to remain stable, both positive and negative changes were observed over the first year. Larger studies are needed to determine psychosocial risks and benefit and what additional resources might be needed to ensure optimal psychosocial outcomes.
COVID-19 vaccine uptake in the United States has proved challenging. A deeper characterization extending beyond demographics and political ideologies of those hesitating or resisting is needed to guide ongoing conversations. This study examined associations between US adults' vaccination intentions and mental health history, experience of the COVID-19 pandemic, and mental health outcomes. An online population-based cross-sectional survey was administered nationwide during January 4-7, 2021. Participants were questioned about past and current mental health, and completed the Patient Health Questionnaire 8 (PHQ-8), Generalized Anxiety Disorder 7-item (GAD-7), and Posttraumatic Diagnostic Scale (PDS)-5 (to capture symptoms of depression, anxiety, and traumatic stress, respectively). Experience of the pandemic included cumulative county-level COVID case and death rates, self-reported COVID-19 testing/exposure/diagnosis, and self-reported impact on routines, resources, and relationships. Of 936 respondents, 66% intended to be vaccinated, 14.7% responded "maybe," and 19.6% "no." Past diagnosis of obsessive compulsive disorder, less impact on routines or social supports, not having been screened or tested for COVID-19, not knowing someone who tested positive, and not self-isolating were associated with less intention to vaccinate. After controlling for demographic and pandemic experience factors, symptoms of traumatic stress, but not other mental health outcomes, were associated with less intention to vaccinate. The apparent contradiction between less negative impact of the pandemic and symptoms of traumatic stress being associated with less intention to be vaccinated indicates the complex nature of barriers to vaccine uptake. Results from this study contribute to the evidence base needed to improve ongoing and future communications about, and strategies to increase uptake of, vaccination.
Objectives: Information regarding vaccination and the association with individuals' characteristics, experiences, and information sources is important for crafting public health campaigns to maximize uptake. Our objective was to investigate factors associated with intentions for COVID-19 vaccination among a sample of U.S. adults using a population-based cross-sectional survey. Method: Data were collected via an online questionnaire administered nationwide from January 4, to January 7, 2021 following the emergency use authorization for two SARS-CoV-2 mRNA-based vaccines. Results: Of 936 U.S. adult respondents, 66% stated an intention to be vaccinated once a COVID-19 vaccine was available to them; 14.7% responded "maybe" and 19.6% "no." Unadjusted and multivariate associations revealed "no/maybe" vaccination intentions were associated with younger age, female, Black race, lower income, history of not receiving the influenza vaccine, lower fear of COVID-19, suffering moderate to severe reduction in access to food/nutrition, and lower trust in health care authorities, personal health care providers, and/or traditional news media as sources of COVID-19 information. Of respondents "maybe" intending to be vaccinated, 65% reported "a lot" of trust in personal health care providers as sources of COVID-19 information. Respondents stating "no" intention to be vaccinated were skeptical of all COVID-19 information sources considered. Conclusions: Our findings confirm observations predating COVID-19 vaccine availability regarding sociodemographic characteristics associated with vaccine hesitancy in the United States. We further identify personal health care providers as the most trusted information source among people who "maybe" intend to get vaccinated and demonstrate the challenge in reaching people not intending to be vaccinated.
Background: Scant research has focused on posttraumatic stress disorder (PTSD) in the SCI population, despite high prevalence estimates. Fortunately, prolonged exposure therapy (PE) is a well-researched and highly effective treatment for PTSD. Our recent clinical trial showed that standard 12-session PE was effective for PTSD treatment among inpatients with SCI. Early intervention with brief PE (3-sessions) delivered in the emergency department has also been effective for PTSD prevention, but has not been tested among people post-SCI. Thus, we aim to conduct the first test of the Brief PE intervention to prevent PTSD among patients with SCI. Methods: Adults who have experienced a SCI (N = 200) will be randomly assigned during inpatient rehabilitation to either: (a) 3 60-min sessions of Brief PE (intervention group) or (b) treatment as usual (control group). Results: The primary outcome measure (PTSD symptoms measured by the PSSI-5) and secondary outcome measures (depression, anxiety, pain, quality of life, sleep disturbance, and resilience) will be assessed at baseline, 1-month, 3-months, and 6-months. Hierarchical linear modeling (HLM) will be used to evaluate the effectiveness of the PE intervention on PTSD and secondary outcomes. Descriptive statistics will examine feasibility and will include the number of participants enrolled, the number of sessions completed, fidelity of Brief PE delivery, and average scores for difficulty and helpfulness of the intervention scales for those randomized to intervention. Conclusions: Successful completion of this study will provide an evidence-based program to alleviate posttraumatic distress post spinal cord injury and prevent long-term development of PTSD.