The impact of restrictions on psychological outcomes in patients with inflammatory bowel disease on biological treatment during the coronavirus pandemic in Norway.

PURPOSE: The coronavirus (COVID-19) pandemic restrictions have led to changes in the follow-up routine of patients in outpatient clinics at hospitals in Norway. The purpose of this study was to assess possible associations between psychological health and concerns regarding COVID-19 societal and hospital restrictions in patients with inflammatory bowel disease on biological therapy. METHODS: Patients with IBD (≥ 18 years) undergoing biological treatment (TNF-alpha inhibitor, ustekinumab, vedolizumab) for IBD were recruited from an IBD outpatient clinic in Norway. Data were collected through self-report, including questions covering concerns regarding their disease, medical therapy, and follow-up during the pandemic, Patient Health Questionnaire-9 (PHQ-9) and Generalized Anxiety Disorder-7 questionnaire (GAD-7). Multiple logistic regression with backward conditional selection was fitted to examine associations between patients' depression and anxiety levels and their concerns about COVID-19 restrictions, controlled for sociodemographic and disease-related factors. RESULTS: Five-hundred and six patients were included in this study. General condition, self-isolation, employment status, fear of visiting the hospital, and changes to patients' appointments made by the hospital were independently associated with higher levels of depression. Female gender, experiencing symptoms of COVID-19, self-isolation, experiencing an increased risk of COVID-19 because of IBD, being afraid to visit the hospital because of COVID-19 restrictions, and having their appointment cancelled due to COVID-19 were independently associated with higher anxiety levels. CONCLUSION: Concerns about physical health and societal and hospital restrictions were associated with anxiety and depression in patients with IBD undergoing biological treatment. The findings will help facilitate healthcare services for patients with IBD in outpatient clinics and develop guidelines for follow-up.

Post-traumatic stress symptoms six months after ICU admission with COVID-19: Prospective observational study.

AIMS AND OBJECTIVES: The aim of this study was to investigate the prevalence of post-traumatic stress symptoms, and to identify possible predictive factors in Norwegian intensive care unit survivors, 6 months after admission to the intensive care unit with COVID-19. BACKGROUND: The SARS CoV-2 virus causing COVID-19 has spread worldwide since it was declared a pandemic in March 2020. The most severely ill patients have been treated in the intensive care due to acute respiratory failure and also acute respiratory distress syndrome. It is well documented that these severe conditions can lead to complex and long-lasting symptoms, such as psychological distress, and was, therefore, investigated for the specific COVID-19 population. DESIGN: Prospective observational study. METHODS: Clinical data and patient reported outcome measures were collected by the Norwegian Intensive Care and Pandemic Registry and by the study group 6 months after admission to an intensive care unit. RESULTS: Among 222 COVID-19 patients admitted to Norwegian intensive care units between 10 March and 6 July 2020, 175 survived. The study sample consisted of 131 patients who responded to at least one patient reported outcome measure at 6 months following admission. The primary outcome was self-reported post-traumatic stress symptoms, using the Impact of Event Scale-6 (n = 89). Of those, 22.5% reported post-traumatic stress symptoms 6 months after admission. Female gender, younger age and having a high respiratory rate at admission were statistically significant predictive factors for reporting post-traumatic stress symptoms. CONCLUSIONS: The result is in accordance with previously published research with comparable populations, suggesting that for many COVID-19 survivors psychological distress is a part of the post-acute sequelae. Results from the present study should be replicated in larger datasets. RELEVANCE TO CLINICAL PRACTICE: This project provides important insight to post-acute sequelae after COVID-19 that patients may experience after critical illness.

Cognitive rehabilitation in post-COVID-19 condition: A study protocol for a randomized controlled trial.

BACKGROUND: Post-COVID-19 condition is frequently comprised of persistent cognitive sequela, including deficits in attention and executive functions (EFs), which can act as a barrier for regaining pre-illness functional levels. Goal Management Training (GMT) is a cognitive rehabilitation (CR) intervention for improving attention and EFs that has received empirical support in studies of other patient groups. The present study aims to determine the efficacy of GMT for improving everyday attention and EFs in adults who experience persistent cognitive deficits after COVID-19. METHODS: This study protocol describes an open-label randomized controlled trial comparing the efficacy of GMT to a wait list control condition (WL), for improving persistent (> 2 months) cognitive sequela in post-COVID-19 condition. The study aims to recruit 240 participants aged 18 to 65 years with a history of SARS-CoV-2 infection and perceived attentional and EF difficulties in daily life. Participants will be block randomized (computer-algorithm) to either group-based GMT (n = 120) or WL (n = 120). GMT will be internet-delivered to groups of six participants in six two-hour sessions delivered once a week. The primary outcome will be the Metacognition Index of the Behavior Rating Inventory of Executive Function - Adult Version, a self-report measure assessing everyday EF difficulties, specifically metacognition, at six months post-treatment. Secondary outcomes include performance-based neurocognitive measures, and tertiary outcomes include rating scales of cognition, emotional health, quality of life, and fatigue. CONCLUSION: Study findings could contribute to providing an evidence-based treatment option for symptoms that are frequent and debilitating following a prevalent condition. TRIAL REGISTRATION NUMBER: NCT05494424.

Cognitive rehabilitation in post-COVID-19 condition: A study protocol for a randomized controlled trial

Background Post-COVID-19 condition is frequently comprised of persistent cognitive sequela, including deficits in attention and executive functions (EFs), which can act as a barrier for regaining pre-illness functional levels. Goal Management Training (GMT) is a cognitive rehabilitation (CR) intervention for improving attention and EFs that has received empirical support in studies of other patient groups. The present study aims to determine the efficacy of GMT for improving everyday attention and EFs in adults who experience persistent cognitive deficits after COVID-19. Methods This study protocol describes an open-label randomized controlled trial comparing the efficacy of GMT to a wait list control condition (WL), for improving persistent (> 2 months) cognitive sequela in post-COVID-19 condition. The study aims to recruit 240 participants aged 18 to 65 years with a history of SARS-CoV-2 infection and perceived attentional and EF difficulties in daily life. Participants will be block randomized (computer-algorithm) to either group-based GMT (n = 120) or WL (n = 120). GMT will be internet-delivered to groups of six participants in six two-hour sessions delivered once a week. The primary outcome will be the Metacognition Index of the Behavior Rating Inventory of Executive Function – Adult Version, a self-report measure assessing everyday EF difficulties, specifically metacognition, at six months post-treatment. Secondary outcomes include performance-based neurocognitive measures, and tertiary outcomes include rating scales of cognition, emotional health, quality of life, and fatigue. Conclusion Study findings could contribute to providing an evidence-based treatment option for symptoms that are frequent and debilitating following a prevalent condition. Trial registration number NCT05494424

Changes in health-related quality of life in adolescents and the impact of gender and selected variables: a two-year longitudinal study.

BACKGROUND: Increased knowledge about factors that can impact changes in adolescents' health-related quality of life (HRQOL) is needed. The present study aimed to investigate possible HRQOL changes in adolescents at 14 and 16 years, and assess the impact of sociodemographic factors, gender, pain, self-esteem, self-efficacy, loneliness, and stress on HRQOL changes over time. Further, to assess HRQOL stratified by gender. METHODS: A longitudinal study involving 211 adolescents was conducted. Sociodemographic variables, pain, self-esteem, self-efficacy, loneliness, and stress were all assessed with well-validated instruments. KIDSCREEN-27 was used to measure HRQOL. Data were analyzed using independent t-tests, paired samples t-tests, and linear mixed models for repeated measures. RESULTS: When all variables were added to the linear mixed models, stress, loneliness, and pain were significantly, independently associated with a reduction in HRQOL change scores for four of the five KIDSCREEN subscales. Time was significantly associated with a reduction in physical and psychological well-being. Self-efficacy and self-esteem were significantly associated with an increase in HRQOL change scores for four and two subscales, respectively. Male gender was significantly negatively associated with changes in social support and peers compared to female gender. CONCLUSION: Our results demonstrated a significant decline in adolescents' HRQOL regarding physical and psychological well-being for the age range 14-16 years. Furthermore, we found that stress, loneliness, and pain have a significant negative impact on HRQOL changes, whereas self-esteem and self-efficacy have a significant positive impact. Our results highlight the importance of increased understanding regarding factors associated with changes in adolescents' HRQOL to enable accurate and strategic interventions.

Health-related quality of life, health literacy and COVID-19-related worries of 16- to 17-year-old adolescents and parents one year into the pandemic: a cross-sectional study.

BACKGROUND: The uncertain and challenging situation caused by the COVID-19 pandemic affects adolescents and their parents in an exceptional way. More knowledge of health-related quality of life (HRQoL), health literacy (HL) and COVID-19-related worries in adolescents and parents 1 year into the pandemic is needed. The present study aimed to describe HRQoL, HL and COVID-19-related worries of 16- to 17-year-old adolescents and parents of adolescents. Further, to assess the strength of associations between gender, HL, COVID-19-related worries and HRQoL. METHODS: A cross-sectional study involving 215 adolescents and 320 parents was conducted, exploring HRQoL, HL, COVID-19-related worries and sociodemographic variables. KIDSCREEN-10 and RAND-36 were used to measure HRQoL. Data were analyzed using bivariate methods, multiple linear regression and robust regression. RESULTS: Adolescents' HRQoL was notably lower compared to previous Norwegian studies and European norms. Parents' HRQoL was comparable to Norwegian norms. Adolescents and parents reported moderate-to-high HL and high degrees of COVID-19-related worries. Females reported significantly lower HRQoL and more worries compared to males. In adolescents, higher HL was significantly associated with higher HRQoL. COVID-19-related worries were not significantly associated with HRQoL. In parents, higher HL in the "understand health information" domain was significantly associated with higher HRQoL for mental well-being (mental component sum scores [MCS]) and with lower HRQoL for physical well-being (physical component sum scores [PCS]). Being worried a lot about infecting others and about family/friends becoming sick was significantly associated with higher MCS and lower MCS, respectively. COVID-19-related worries were not significantly associated with PCS. CONCLUSIONS: Our results indicate that the pandemic has a major negative impact on adolescents' HRQoL. Parents' HRQoL remained unchanged and comparable to previous studies. Our study demonstrates that HL, gender and COVID-19-related worries are significantly associated with adolescents' and parents' HRQoL, indicating that efforts aimed at increasing their HL might indirectly affect their HRQoL as well and that gender-specific interventions or strategies could be beneficial.